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Veliparib With or Without Radiation Therapy, Carboplatin, and Paclitaxel in Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

Primary Purpose

Lung Adenocarcinoma, Lung Adenocarcinoma, Mixed Subtype, Lung Large Cell Carcinoma

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
3-Dimensional Conformal Radiation Therapy
Carboplatin
Laboratory Biomarker Analysis
Paclitaxel
Placebo Administration
Veliparib
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have histologically or cytologically-proven new diagnosis of unresectable stage IIIA/IIIB*, non-small cell lung cancer (adenocarcinoma, bronchioloalveolar cell carcinoma, large cell carcinoma, squamous cell carcinoma, or mixed)

    • Per the American Joint Committee on Cancer (AJCC) 7th edition, pleural and pericardial are now considered stage M1a disease; when pleural fluid is visible on the computed tomography (CT) scan or on a chest x-ray, a thoracentesis is required to confirm that the pleural fluid is cytologically negative; patients with exudative pleural effusions are excluded, regardless of cytology; patients with effusions that are minimal (i.e. not visible on chest x-ray) that are too small to safely tap are eligible; a small effusion that has positive fludeoxyglucose F 18 (FDG) uptake on positron emission tomography (PET) has to be proven to be malignant per standard of care diagnostic procedures for the patient to be excluded
  • Patients must have measurable or non-measurable disease documented by CT, magnetic resonance imaging (MRI) or PET/CT; the CT from a combined PET/CT may be used to document only non-measurable disease unless the scan is of diagnostic quality; measurable disease must be assessed by CT within 28 days prior to registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form
  • Patients with brain metastases are ineligible; all patients must have a pretreatment CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to registration
  • Patients must not have received any prior systemic therapy (chemotherapy or other biologic therapy) for lung cancer
  • Patients must not have received prior chest radiation therapy for NSCLC
  • Patients must not have had a previous surgical resection; however, patients may have undergone exploratory thoracotomy, mediastinoscopy, excisional biopsy or similar surgery for the purpose of determining the diagnosis, stage or potential resectability of newly diagnosed lung tumor; at least 28 days must have elapsed since thoracic surgery (excluding mediastinoscopy or other minor surgeries) and patients should have recovered from all associated toxicities at the time of registration; patients must not be planning to undergo a minor surgical procedure while on this study
  • Patients must have Zubrod performance status 0-1
  • Patients must have tumor tissue available for submission to assess gene expression of ERCC1 and XRCC1; patients must also be offered participation in banking for future use of specimens
  • Absolute neutrophil count >= 1,500/mcl
  • Platelets >= 100,000/mcl
  • Hemoglobin >= 9.0 g/dl
  • Total bilirubin within institutional upper limit of normal (IULN)
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x IULN
  • Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • Patients must have a serum creatinine =< the IULN AND measured or calculated creatinine clearance >= 60 cc/min using the Cockroft-Gault formula
  • Patients must have pulmonary function tests (PFTs) including forced expiratory volume in 1 second (FEV1) within 84 days prior to registration; for FEV1, the best value obtained pre- or post-bronchodilator must be >= 1.2 liters/second and/or >= 50% predicted
  • Patients may not be planning to receive any other investigational agents
  • Patients must not have more than 10% weight loss in the past 6 months
  • Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888, carboplatin, paclitaxel or other agents used in study
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
  • Patient must not have any uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients must not currently have a > grade 1 symptomatic neuropathy-sensory (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.0)
  • Patients must not have a history of seizures
  • Patients must not have any known immune deficiencies; patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; therefore, known human immunodeficiency virus (HIV) positive patients receiving combination anti-retroviral therapy are excluded from the study
  • Patients must be able to swallow whole capsules
  • Prestudy history and physical must be obtained within 28 days prior to registration
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY:
  • REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have completed chemoradiotherapy per protocol and at least four weeks but no more than six weeks must have elapsed from the last day of induction therapy (the last day of radiation)
  • REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have undergone restaging tests according to the study calendar and determined to have no evidence of disease progression
  • REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have a serum creatinine =< (IULN) AND measured of calculated creatinine clearance >= 60 cc/min using the Cockroft-Gault formula
  • REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Absolute neutrophil count >= 1,500 mcl
  • REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Platelets >= 100,000/mcl
  • REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Hemoglobin >= 9.0 g/dl
  • REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Total bilirubin =< IULN
  • REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: SGOT (AST) or SGPT (ALT) =< 2.5 x IULN
  • REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have Zubrod performance status 0-1

Sites / Locations

  • Anchorage Associates in Radiation Medicine
  • Alaska Breast Care and Surgery LLC
  • Alaska Oncology and Hematology LLC
  • Alaska Women's Cancer Care
  • Anchorage Oncology Centre
  • Katmai Oncology Group
  • Providence Alaska Medical Center
  • Banner University Medical Center - Tucson
  • University of Arizona Cancer Center-North Campus
  • Tower Cancer Research Foundation
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
  • City of Hope Corona
  • City of Hope Comprehensive Cancer Center
  • Los Angeles County-USC Medical Center
  • USC / Norris Comprehensive Cancer Center
  • Mercy UC Davis Cancer Center
  • University of California Davis Comprehensive Cancer Center
  • UCHealth University of Colorado Hospital
  • Yale University
  • Pali Momi Medical Center
  • Queen's Cancer Center - Pearlridge
  • The Cancer Center of Hawaii-Pali Momi
  • Hawaii Cancer Care Inc - Waterfront Plaza
  • Queen's Cancer Cenrer - POB I
  • Queen's Medical Center
  • Straub Clinic and Hospital
  • University of Hawaii Cancer Center
  • Hawaii Cancer Care Inc-Liliha
  • Queen's Cancer Center - Kuakini
  • The Cancer Center of Hawaii-Liliha
  • Kapiolani Medical Center for Women and Children
  • Wilcox Memorial Hospital and Kauai Medical Clinic
  • Saint Luke's Cancer Institute - Boise
  • Kootenai Health - Coeur d'Alene
  • Saint Luke's Cancer Institute - Fruitland
  • Saint Luke's Cancer Institute - Meridian
  • Saint Luke's Cancer Institute - Nampa
  • Kootenai Clinic Cancer Services - Post Falls
  • Kootenai Cancer Clinic
  • Saint Luke's Cancer Institute - Twin Falls
  • Rush - Copley Medical Center
  • Saint Joseph Medical Center
  • Illinois CancerCare-Bloomington
  • Illinois CancerCare-Canton
  • Memorial Hospital of Carbondale
  • SIH Cancer Institute
  • Illinois CancerCare-Carthage
  • Centralia Oncology Clinic
  • Northwestern University
  • Carle at The Riverfront
  • Cancer Care Specialists of Illinois - Decatur
  • Carle Physician Group-Effingham
  • Crossroads Cancer Center
  • Illinois CancerCare-Eureka
  • Illinois CancerCare-Galesburg
  • Western Illinois Cancer Treatment Center
  • Illinois CancerCare-Kewanee Clinic
  • Illinois CancerCare-Macomb
  • Carle Physician Group-Mattoon/Charleston
  • Loyola University Medical Center
  • Good Samaritan Regional Health Center
  • Cancer Care Center of O'Fallon
  • Illinois CancerCare-Ottawa Clinic
  • Illinois CancerCare-Pekin
  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
  • Illinois CancerCare-Peoria
  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
  • Methodist Medical Center of Illinois
  • OSF Saint Francis Medical Center
  • Illinois CancerCare-Peru
  • Valley Radiation Oncology
  • Illinois CancerCare-Princeton
  • Central Illinois Hematology Oncology Center
  • Southern Illinois University School of Medicine
  • Springfield Clinic
  • Memorial Medical Center
  • Southwest Illinois Health Services LLP
  • Carle Cancer Center
  • The Carle Foundation Hospital
  • Rush-Copley Healthcare Center
  • Fort Wayne Medical Oncology and Hematology Inc-Parkview
  • Reid Health
  • McFarland Clinic - Ames
  • Siouxland Regional Cancer Center
  • Cancer Center of Kansas - Chanute
  • Cancer Center of Kansas - Dodge City
  • Cancer Center of Kansas - El Dorado
  • Cancer Center of Kansas - Fort Scott
  • Saint Catherine Hospital
  • Central Care Cancer Center - Great Bend
  • HaysMed University of Kansas Health System
  • Cancer Center of Kansas-Independence
  • University of Kansas Cancer Center-West
  • University of Kansas Cancer Center
  • Cancer Center of Kansas-Kingman
  • Lawrence Memorial Hospital
  • Cancer Center of Kansas-Liberal
  • Cancer Center of Kansas-Manhattan
  • Cancer Center of Kansas - McPherson
  • Cancer Center of Kansas - Newton
  • Olathe Health Cancer Center
  • University of Kansas Cancer Center-Overland Park
  • Cancer Center of Kansas - Parsons
  • Ascension Via Christi - Pittsburg
  • Cancer Center of Kansas - Pratt
  • Cancer Center of Kansas - Salina
  • Salina Regional Health Center
  • University of Kansas Health System Saint Francis Campus
  • Cancer Center of Kansas - Wellington
  • University of Kansas Hospital-Westwood Cancer Center
  • Associates In Womens Health
  • Cancer Center of Kansas-Wichita Medical Arts Tower
  • Ascension Via Christi Hospitals Wichita
  • Cancer Center of Kansas - Wichita
  • Wesley Medical Center
  • Cancer Center of Kansas - Winfield
  • Lahey Hospital and Medical Center
  • Bronson Battle Creek
  • Wayne State University/Karmanos Cancer Institute
  • Henry Ford Hospital
  • Spectrum Health at Butterworth Campus
  • Trinity Health Grand Rapids Hospital
  • West Michigan Cancer Center
  • Trinity Health Muskegon Hospital
  • Lakeland Hospital Niles
  • Spectrum Health Reed City Hospital
  • Lakeland Medical Center Saint Joseph
  • Marie Yeager Cancer Center
  • Munson Medical Center
  • University of Michigan Health - West
  • Sanford Joe Lueken Cancer Center
  • Baptist Memorial Hospital and Cancer Center-Desoto
  • Saint Louis Cancer and Breast Institute-Ballwin
  • Parkland Health Center-Bonne Terre
  • Saint Francis Medical Center
  • Southeast Cancer Center
  • Capital Region Southwest Campus
  • Freeman Health System
  • Mercy Hospital Joplin
  • Truman Medical Centers
  • Kansas City Veterans Affairs Medical Center
  • The University of Kansas Cancer Center-South
  • University of Kansas Cancer Center - North
  • University of Kansas Cancer Center - Lee's Summit
  • Delbert Day Cancer Institute at PCRMC
  • Saint Louis Cancer and Breast Institute-South City
  • Missouri Baptist Medical Center
  • Mercy Hospital Saint Louis
  • Sainte Genevieve County Memorial Hospital
  • Mercy Hospital Springfield
  • CoxHealth South Hospital
  • Missouri Baptist Sullivan Hospital
  • Missouri Baptist Outpatient Center-Sunset Hills
  • Mercy Hospital Washington
  • Community Hospital of Anaconda
  • Billings Clinic Cancer Center
  • Bozeman Deaconess Hospital
  • Benefis Healthcare- Sletten Cancer Institute
  • Great Falls Clinic
  • Saint Peter's Community Hospital
  • Kalispell Regional Medical Center
  • Saint Patrick Hospital - Community Hospital
  • Community Medical Hospital
  • Hendersonville Hematology and Oncology at Pardee
  • Margaret R Pardee Memorial Hospital
  • Vidant Oncology-Kinston
  • FirstHealth of the Carolinas-Moore Regional Hospital
  • Sanford Bismarck Medical Center
  • Sanford Broadway Medical Center
  • Sanford Roger Maris Cancer Center
  • Cleveland Clinic Mercy Hospital
  • Dayton Physicians LLC-Miami Valley South
  • Miami Valley Hospital South
  • Oncology Hematology Care Inc-Kenwood
  • Good Samaritan Hospital - Dayton
  • Miami Valley Hospital
  • Dayton Physician LLC-Miami Valley Hospital North
  • Miami Valley Hospital North
  • Armes Family Cancer Center
  • Blanchard Valley Hospital
  • Orion Cancer Care
  • Atrium Medical Center-Middletown Regional Hospital
  • Dayton Physicians LLC-Atrium
  • Dayton Physicians LLC-Wayne
  • Wayne Hospital
  • Greater Dayton Cancer Center
  • Kettering Medical Center
  • Dayton Physicians LLC-Signal Point
  • Dayton Physicians LLC-Wilson
  • Springfield Regional Cancer Center
  • Springfield Regional Medical Center
  • Dayton Physicians LLC - Troy
  • Upper Valley Medical Center
  • University of Oklahoma Health Sciences Center
  • Saint Charles Health System
  • Clackamas Radiation Oncology Center
  • Providence Cancer Institute Clackamas Clinic
  • Bay Area Hospital
  • Providence Newberg Medical Center
  • Providence Willamette Falls Medical Center
  • Providence Portland Medical Center
  • Providence Saint Vincent Medical Center
  • Penn State Health Saint Joseph Medical Center
  • Sanford Cancer Center Oncology Clinic
  • Sanford USD Medical Center - Sioux Falls
  • Baptist Memorial Hospital and Cancer Center-Collierville
  • Baptist Memorial Hospital and Cancer Center-Memphis
  • M D Anderson Cancer Center
  • Audie L Murphy VA Hospital
  • Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
  • University Hospital
  • University of Texas Health Science Center at San Antonio
  • Providence Regional Cancer System-Aberdeen
  • PeaceHealth Saint Joseph Medical Center
  • Providence Regional Cancer System-Centralia
  • Swedish Cancer Institute-Edmonds
  • Providence Regional Cancer Partnership
  • Swedish Cancer Institute-Issaquah
  • Kadlec Clinic Hematology and Oncology
  • Providence Regional Cancer System-Lacey
  • PeaceHealth Saint John Medical Center
  • Pacific Gynecology Specialists
  • Swedish Medical Center-Ballard Campus
  • Kaiser Permanente Washington
  • Swedish Medical Center-Cherry Hill
  • Swedish Medical Center-First Hill
  • Providence Regional Cancer System-Shelton
  • MultiCare Deaconess Cancer and Blood Specialty Center - Valley
  • MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
  • MultiCare Deaconess Cancer and Blood Specialty Center - North
  • PeaceHealth Southwest Medical Center
  • Providence Saint Mary Regional Cancer Center
  • Providence Regional Cancer System-Yelm
  • Billings Clinic-Cody
  • Welch Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (RT, veliparib, carboplatin, paclitaxel)

Arm II (3D-CRT, placebo, carboplatin, paclitaxel)

Arm Description

Patients undergo 3D-CRT and receive veliparib, carboplatin, and paclitaxel as in Phase I induction and consolidation therapy.

Patients undergo 3D-CRT as in arm I. Patients also receive placebo PO BID on days 1-43 and carboplatin and paclitaxel as in Phase I. Within 4-6 weeks after completion of chemotherapy and radiation therapy, patients receive placebo on days 1-7 and carboplatin and paclitaxel as in Phase I.

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose of Veliparib When Given Concurrently With Standard Carboplatin/Paclitaxel and Radiotherapy, Determined According to Incidence of Dose Limiting Toxicity (DLT) (Phase I)
DLTs will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. DLTs must be attributable (probably, possibly, definitely related) to the study regimen and only occur during RT or 2 weeks after completing RT. DLTs are defined as: Radiation esophagitis or dermatitis radiation Grade 3 that lasts > 7 consecutive days or Grade 4 Grade 4 neutropenia for > 7 days or neutropenic fever ( ANC <500 and temperature >= 38.5 oC) Grade 4 thrombocytopenia Grade 4 nausea/vomiting despite appropriate antiemetic therapy Delays in radiotherapy or chemotherapy or ABT-888 due to toxicity of > 3 weeks All other non-hematologic toxicities >= Grade 3, except anorexia fatigue infection without neutropenia Grade 3 AST/ALT elevations <= 7 days, infusion reactions Grade 3 or 4 lymphopenia Grade 3 or 4 electrolyte abnormalities that are corrected to <=Grade 2 in < 48 hours Grade 3 dehydration lasting < 7 days
Progression-free Survival of Patients Treated With Chemoradiotherapy Plus Veliparib (Phase II)
Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause. Participants last known to be alive are censored at date of last contact. Assessed by Response Evaluation Criteria in Solid Tumors, RECIST 1.1

Secondary Outcome Measures

Overall Survival (Phase II)
From date of registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact.
Objective Response Rate (Phase II)
ORR is defined as the percentage of participants with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II)
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Full Information

First Posted
June 30, 2011
Last Updated
October 24, 2023
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01386385
Brief Title
Veliparib With or Without Radiation Therapy, Carboplatin, and Paclitaxel in Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
Official Title
A Dose Finding Study Followed by Phase II Randomized, Placebo-Controlled Study of Veliparib (ABT-888) Added to Chemoradiotherapy With Carboplatin and Paclitaxel for Unresectable Stage III Non-small Cell Lung Cancer (NSCLC), (NCI Study Number 8811)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 20, 2011 (Actual)
Primary Completion Date
May 26, 2019 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This phase I/II partially randomized trial studies the side effects and best dose of veliparib when given together with radiation therapy, carboplatin, and paclitaxel and to see how well it works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether radiation therapy, carboplatin, and paclitaxel are more effective with or without veliparib in treating non-small cell lung cancer.
Detailed Description
PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose (MTD) and the recommended phase II dose of ABT-888 (veliparib) when given concurrently with standard carboplatin/paclitaxel and radiotherapy in patients with unresectable stage III non-small cell lung cancer (NSCLC). (Phase I) II. To assess whether carboplatin/paclitaxel plus ABT-888 compared with carboplatin/paclitaxel plus placebo improves progression-free survival (PFS) in patients with unresectable stage III NSCLC. (Phase II) III. To compare overall survival (OS) in patients treated with carboplatin/paclitaxel and radiotherapy plus ABT-888 to those treated with carboplatin, paclitaxel and radiotherapy plus placebo. (Phase II) IV. To assess the response rate (confirmed and unconfirmed, complete and partial responses) and disease control rate in the subset of patients with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. (Phase II) V. To assess the safety and toxicity profile of the regimen. (Phase II) SECONDARY OBJECTIVES: I. To collect tumor tissue from pretreatment biopsies (archival samples) for biomarker studies, including poly (ADP-ribose) polymerase 1 (PARP) activity by measuring the levels of poly-ADP-ribose, gamma-H2A histone family, member X (gamma-H2AX), and messenger ribonucleic acid (mRNA) expression levels of deoxyribonucleic acid (DNA) repair enzymes such as excision repair cross-complementing rodent repair deficiency, complementation group 1 (ERCC1)/x-ray repair complementing defective repair in Chinese hamster cells 1 (XRCC1). II. To collect blood samples for evaluation of gamma-H2AX (circulating tumor cells) and other relevant future studies. OUTLINE: This is a phase I, dose-escalation study of veliparib followed by a randomized phase II study. PHASE I: INDUCTION THERAPY: Patients undergo 3-dimensional conformal radiation therapy (3D-CRT) once daily (QD), 5 days a week, for 6 weeks. Patients also receive veliparib orally (PO) twice daily (BID) on days 1-43 and carboplatin intravenously (IV) over 30 minutes and paclitaxel IV over 1 hour on days 1, 8, 15, 22, 36, and 43 in the absence of disease progression or unacceptable toxicity. Patients without disease progression after completion of chemoradiotherapy undergo consolidation therapy. CONSOLIDATION THERAPY: Beginning within 4-6 weeks of chemotherapy and radiation therapy, patients receive veliparib PO BID on days 1-7 (course 1) and 22-28 (course 2) and carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1 and on day 22 of course 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo 3D-CRT and receive veliparib, carboplatin, and paclitaxel as in Phase I induction and consolidation therapy. ARM II: Patients undergo 3D-CRT as in arm I. Patients also receive placebo PO BID on days 1-43 and carboplatin and paclitaxel as in Phase I. Within 4-6 weeks after completion of chemotherapy and radiation therapy, patients receive placebo on days 1-7 and carboplatin and paclitaxel as in Phase I. After completion of study treatment, patients are followed up every 4 months for first 2 years and then every 6 months until 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Adenocarcinoma, Lung Adenocarcinoma, Mixed Subtype, Lung Large Cell Carcinoma, Lung Squamous Cell Carcinoma, Minimally Invasive Lung Adenocarcinoma, Stage III Lung Non-Small Cell Cancer AJCC v7, Stage IIIA Lung Non-Small Cell Cancer AJCC v7, Stage IIIB Lung Non-Small Cell Cancer AJCC v7

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (RT, veliparib, carboplatin, paclitaxel)
Arm Type
Experimental
Arm Description
Patients undergo 3D-CRT and receive veliparib, carboplatin, and paclitaxel as in Phase I induction and consolidation therapy.
Arm Title
Arm II (3D-CRT, placebo, carboplatin, paclitaxel)
Arm Type
Active Comparator
Arm Description
Patients undergo 3D-CRT as in arm I. Patients also receive placebo PO BID on days 1-43 and carboplatin and paclitaxel as in Phase I. Within 4-6 weeks after completion of chemotherapy and radiation therapy, patients receive placebo on days 1-7 and carboplatin and paclitaxel as in Phase I.
Intervention Type
Radiation
Intervention Name(s)
3-Dimensional Conformal Radiation Therapy
Other Intervention Name(s)
3-dimensional radiation therapy, 3D Conformal, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D radiotherapy, 3D-CRT, Conformal Therapy, Radiation Conformal Therapy, Radiation, 3D Conformal, Three dimensional external beam radiation therapy (procedure)
Intervention Description
Undergo 3D-conformal RT
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Placebo Administration
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Veliparib
Other Intervention Name(s)
ABT-888, PARP-1 inhibitor ABT-888
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose of Veliparib When Given Concurrently With Standard Carboplatin/Paclitaxel and Radiotherapy, Determined According to Incidence of Dose Limiting Toxicity (DLT) (Phase I)
Description
DLTs will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. DLTs must be attributable (probably, possibly, definitely related) to the study regimen and only occur during RT or 2 weeks after completing RT. DLTs are defined as: Radiation esophagitis or dermatitis radiation Grade 3 that lasts > 7 consecutive days or Grade 4 Grade 4 neutropenia for > 7 days or neutropenic fever ( ANC <500 and temperature >= 38.5 oC) Grade 4 thrombocytopenia Grade 4 nausea/vomiting despite appropriate antiemetic therapy Delays in radiotherapy or chemotherapy or ABT-888 due to toxicity of > 3 weeks All other non-hematologic toxicities >= Grade 3, except anorexia fatigue infection without neutropenia Grade 3 AST/ALT elevations <= 7 days, infusion reactions Grade 3 or 4 lymphopenia Grade 3 or 4 electrolyte abnormalities that are corrected to <=Grade 2 in < 48 hours Grade 3 dehydration lasting < 7 days
Time Frame
9 weeks
Title
Progression-free Survival of Patients Treated With Chemoradiotherapy Plus Veliparib (Phase II)
Description
Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause. Participants last known to be alive are censored at date of last contact. Assessed by Response Evaluation Criteria in Solid Tumors, RECIST 1.1
Time Frame
The time from randomization to progression or death due to any cause, assessed up to 5 years
Secondary Outcome Measure Information:
Title
Overall Survival (Phase II)
Description
From date of registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact.
Time Frame
Up to 5 years
Title
Objective Response Rate (Phase II)
Description
ORR is defined as the percentage of participants with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
Time Frame
Up to 5 years
Title
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II)
Description
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame
Duration of treatment and follow up until death or 5 years post registration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have histologically or cytologically-proven new diagnosis of unresectable stage IIIA/IIIB*, non-small cell lung cancer (adenocarcinoma, bronchioloalveolar cell carcinoma, large cell carcinoma, squamous cell carcinoma, or mixed) Per the American Joint Committee on Cancer (AJCC) 7th edition, pleural and pericardial are now considered stage M1a disease; when pleural fluid is visible on the computed tomography (CT) scan or on a chest x-ray, a thoracentesis is required to confirm that the pleural fluid is cytologically negative; patients with exudative pleural effusions are excluded, regardless of cytology; patients with effusions that are minimal (i.e. not visible on chest x-ray) that are too small to safely tap are eligible; a small effusion that has positive fludeoxyglucose F 18 (FDG) uptake on positron emission tomography (PET) has to be proven to be malignant per standard of care diagnostic procedures for the patient to be excluded Patients must have measurable or non-measurable disease documented by CT, magnetic resonance imaging (MRI) or PET/CT; the CT from a combined PET/CT may be used to document only non-measurable disease unless the scan is of diagnostic quality; measurable disease must be assessed by CT within 28 days prior to registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form Patients with brain metastases are ineligible; all patients must have a pretreatment CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to registration Patients must not have received any prior systemic therapy (chemotherapy or other biologic therapy) for lung cancer Patients must not have received prior chest radiation therapy for NSCLC Patients must not have had a previous surgical resection; however, patients may have undergone exploratory thoracotomy, mediastinoscopy, excisional biopsy or similar surgery for the purpose of determining the diagnosis, stage or potential resectability of newly diagnosed lung tumor; at least 28 days must have elapsed since thoracic surgery (excluding mediastinoscopy or other minor surgeries) and patients should have recovered from all associated toxicities at the time of registration; patients must not be planning to undergo a minor surgical procedure while on this study Patients must have Zubrod performance status 0-1 Patients must have tumor tissue available for submission to assess gene expression of ERCC1 and XRCC1; patients must also be offered participation in banking for future use of specimens Absolute neutrophil count >= 1,500/mcl Platelets >= 100,000/mcl Hemoglobin >= 9.0 g/dl Total bilirubin within institutional upper limit of normal (IULN) Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x IULN Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures Patients must have a serum creatinine =< the IULN AND measured or calculated creatinine clearance >= 60 cc/min using the Cockroft-Gault formula Patients must have pulmonary function tests (PFTs) including forced expiratory volume in 1 second (FEV1) within 84 days prior to registration; for FEV1, the best value obtained pre- or post-bronchodilator must be >= 1.2 liters/second and/or >= 50% predicted Patients may not be planning to receive any other investigational agents Patients must not have more than 10% weight loss in the past 6 months Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888, carboplatin, paclitaxel or other agents used in study No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years Patient must not have any uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Patients must not currently have a > grade 1 symptomatic neuropathy-sensory (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) Patients must not have a history of seizures Patients must not have any known immune deficiencies; patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; therefore, known human immunodeficiency virus (HIV) positive patients receiving combination anti-retroviral therapy are excluded from the study Patients must be able to swallow whole capsules Prestudy history and physical must be obtained within 28 days prior to registration All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have completed chemoradiotherapy per protocol and at least four weeks but no more than six weeks must have elapsed from the last day of induction therapy (the last day of radiation) REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have undergone restaging tests according to the study calendar and determined to have no evidence of disease progression REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have a serum creatinine =< (IULN) AND measured of calculated creatinine clearance >= 60 cc/min using the Cockroft-Gault formula REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Absolute neutrophil count >= 1,500 mcl REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Platelets >= 100,000/mcl REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Hemoglobin >= 9.0 g/dl REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Total bilirubin =< IULN REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: SGOT (AST) or SGPT (ALT) =< 2.5 x IULN REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have Zubrod performance status 0-1
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athanassios (Ethan) Argiris
Organizational Affiliation
SWOG Cancer Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anchorage Associates in Radiation Medicine
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
98508
Country
United States
Facility Name
Alaska Breast Care and Surgery LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Alaska Oncology and Hematology LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Alaska Women's Cancer Care
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Anchorage Oncology Centre
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Katmai Oncology Group
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Banner University Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
University of Arizona Cancer Center-North Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Tower Cancer Research Foundation
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Providence Saint Joseph Medical Center/Disney Family Cancer Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
City of Hope Corona
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Los Angeles County-USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Mercy UC Davis Cancer Center
City
Merced
State/Province
California
ZIP/Postal Code
95340
Country
United States
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UCHealth University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Pali Momi Medical Center
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Queen's Cancer Center - Pearlridge
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
The Cancer Center of Hawaii-Pali Momi
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Hawaii Cancer Care Inc - Waterfront Plaza
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Queen's Cancer Cenrer - POB I
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Straub Clinic and Hospital
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
University of Hawaii Cancer Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Hawaii Cancer Care Inc-Liliha
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Queen's Cancer Center - Kuakini
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
The Cancer Center of Hawaii-Liliha
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Wilcox Memorial Hospital and Kauai Medical Clinic
City
Lihue
State/Province
Hawaii
ZIP/Postal Code
96766
Country
United States
Facility Name
Saint Luke's Cancer Institute - Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Kootenai Health - Coeur d'Alene
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Saint Luke's Cancer Institute - Fruitland
City
Fruitland
State/Province
Idaho
ZIP/Postal Code
83619
Country
United States
Facility Name
Saint Luke's Cancer Institute - Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Saint Luke's Cancer Institute - Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Kootenai Clinic Cancer Services - Post Falls
City
Post Falls
State/Province
Idaho
ZIP/Postal Code
83854
Country
United States
Facility Name
Kootenai Cancer Clinic
City
Sandpoint
State/Province
Idaho
ZIP/Postal Code
83864
Country
United States
Facility Name
Saint Luke's Cancer Institute - Twin Falls
City
Twin Falls
State/Province
Idaho
ZIP/Postal Code
83301
Country
United States
Facility Name
Rush - Copley Medical Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Saint Joseph Medical Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Illinois CancerCare-Bloomington
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Illinois CancerCare-Canton
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Memorial Hospital of Carbondale
City
Carbondale
State/Province
Illinois
ZIP/Postal Code
62902
Country
United States
Facility Name
SIH Cancer Institute
City
Carterville
State/Province
Illinois
ZIP/Postal Code
62918
Country
United States
Facility Name
Illinois CancerCare-Carthage
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Centralia Oncology Clinic
City
Centralia
State/Province
Illinois
ZIP/Postal Code
62801
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Carle at The Riverfront
City
Danville
State/Province
Illinois
ZIP/Postal Code
61832
Country
United States
Facility Name
Cancer Care Specialists of Illinois - Decatur
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Carle Physician Group-Effingham
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
Crossroads Cancer Center
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
Illinois CancerCare-Eureka
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Illinois CancerCare-Galesburg
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Western Illinois Cancer Treatment Center
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Illinois CancerCare-Kewanee Clinic
City
Kewanee
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Facility Name
Illinois CancerCare-Macomb
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
Carle Physician Group-Mattoon/Charleston
City
Mattoon
State/Province
Illinois
ZIP/Postal Code
61938
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Good Samaritan Regional Health Center
City
Mount Vernon
State/Province
Illinois
ZIP/Postal Code
62864
Country
United States
Facility Name
Cancer Care Center of O'Fallon
City
O'Fallon
State/Province
Illinois
ZIP/Postal Code
62269
Country
United States
Facility Name
Illinois CancerCare-Ottawa Clinic
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Illinois CancerCare-Pekin
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Illinois CancerCare-Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Illinois CancerCare-Peru
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Valley Radiation Oncology
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Illinois CancerCare-Princeton
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
Central Illinois Hematology Oncology Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
Facility Name
Southwest Illinois Health Services LLP
City
Swansea
State/Province
Illinois
ZIP/Postal Code
62226
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
The Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Rush-Copley Healthcare Center
City
Yorkville
State/Province
Illinois
ZIP/Postal Code
60560
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology Inc-Parkview
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Reid Health
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
McFarland Clinic - Ames
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Siouxland Regional Cancer Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Cancer Center of Kansas - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Cancer Center of Kansas - El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Cancer Center of Kansas - Fort Scott
City
Fort Scott
State/Province
Kansas
ZIP/Postal Code
66701
Country
United States
Facility Name
Saint Catherine Hospital
City
Garden City
State/Province
Kansas
ZIP/Postal Code
67846
Country
United States
Facility Name
Central Care Cancer Center - Great Bend
City
Great Bend
State/Province
Kansas
ZIP/Postal Code
67530
Country
United States
Facility Name
HaysMed University of Kansas Health System
City
Hays
State/Province
Kansas
ZIP/Postal Code
67601
Country
United States
Facility Name
Cancer Center of Kansas-Independence
City
Independence
State/Province
Kansas
ZIP/Postal Code
67301
Country
United States
Facility Name
University of Kansas Cancer Center-West
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66112
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Cancer Center of Kansas-Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Lawrence Memorial Hospital
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66044
Country
United States
Facility Name
Cancer Center of Kansas-Liberal
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67905
Country
United States
Facility Name
Cancer Center of Kansas-Manhattan
City
Manhattan
State/Province
Kansas
ZIP/Postal Code
66502
Country
United States
Facility Name
Cancer Center of Kansas - McPherson
City
McPherson
State/Province
Kansas
ZIP/Postal Code
67460
Country
United States
Facility Name
Cancer Center of Kansas - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Olathe Health Cancer Center
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
Facility Name
University of Kansas Cancer Center-Overland Park
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Cancer Center of Kansas - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
Ascension Via Christi - Pittsburg
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Cancer Center of Kansas - Pratt
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Cancer Center of Kansas - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Salina Regional Health Center
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
University of Kansas Health System Saint Francis Campus
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Cancer Center of Kansas - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
University of Kansas Hospital-Westwood Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Associates In Womens Health
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas-Wichita Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Ascension Via Christi Hospitals Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Wesley Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
Lahey Hospital and Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Bronson Battle Creek
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49017
Country
United States
Facility Name
Wayne State University/Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Spectrum Health at Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Trinity Health Grand Rapids Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Trinity Health Muskegon Hospital
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49444
Country
United States
Facility Name
Lakeland Hospital Niles
City
Niles
State/Province
Michigan
ZIP/Postal Code
49120
Country
United States
Facility Name
Spectrum Health Reed City Hospital
City
Reed City
State/Province
Michigan
ZIP/Postal Code
49677
Country
United States
Facility Name
Lakeland Medical Center Saint Joseph
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Marie Yeager Cancer Center
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
University of Michigan Health - West
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Sanford Joe Lueken Cancer Center
City
Bemidji
State/Province
Minnesota
ZIP/Postal Code
56601
Country
United States
Facility Name
Baptist Memorial Hospital and Cancer Center-Desoto
City
Southhaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
Saint Louis Cancer and Breast Institute-Ballwin
City
Ballwin
State/Province
Missouri
ZIP/Postal Code
63011
Country
United States
Facility Name
Parkland Health Center-Bonne Terre
City
Bonne Terre
State/Province
Missouri
ZIP/Postal Code
63628
Country
United States
Facility Name
Saint Francis Medical Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
Southeast Cancer Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
Capital Region Southwest Campus
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Freeman Health System
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
Mercy Hospital Joplin
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
Truman Medical Centers
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Kansas City Veterans Affairs Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
The University of Kansas Cancer Center-South
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
University of Kansas Cancer Center - North
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Facility Name
University of Kansas Cancer Center - Lee's Summit
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64064
Country
United States
Facility Name
Delbert Day Cancer Institute at PCRMC
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Saint Louis Cancer and Breast Institute-South City
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
Missouri Baptist Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Mercy Hospital Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Sainte Genevieve County Memorial Hospital
City
Sainte Genevieve
State/Province
Missouri
ZIP/Postal Code
63670
Country
United States
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
CoxHealth South Hospital
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Missouri Baptist Sullivan Hospital
City
Sullivan
State/Province
Missouri
ZIP/Postal Code
63080
Country
United States
Facility Name
Missouri Baptist Outpatient Center-Sunset Hills
City
Sunset Hills
State/Province
Missouri
ZIP/Postal Code
63127
Country
United States
Facility Name
Mercy Hospital Washington
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Community Hospital of Anaconda
City
Anaconda
State/Province
Montana
ZIP/Postal Code
59711
Country
United States
Facility Name
Billings Clinic Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Bozeman Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Benefis Healthcare- Sletten Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Saint Peter's Community Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Saint Patrick Hospital - Community Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Community Medical Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Hendersonville Hematology and Oncology at Pardee
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28791
Country
United States
Facility Name
Margaret R Pardee Memorial Hospital
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28791
Country
United States
Facility Name
Vidant Oncology-Kinston
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
FirstHealth of the Carolinas-Moore Regional Hospital
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
Sanford Bismarck Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Sanford Broadway Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Sanford Roger Maris Cancer Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Cleveland Clinic Mercy Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44708
Country
United States
Facility Name
Dayton Physicians LLC-Miami Valley South
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Miami Valley Hospital South
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Oncology Hematology Care Inc-Kenwood
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Good Samaritan Hospital - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Dayton Physician LLC-Miami Valley Hospital North
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Miami Valley Hospital North
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Armes Family Cancer Center
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Blanchard Valley Hospital
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Orion Cancer Care
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Atrium Medical Center-Middletown Regional Hospital
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005-1066
Country
United States
Facility Name
Dayton Physicians LLC-Atrium
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Dayton Physicians LLC-Wayne
City
Greenville
State/Province
Ohio
ZIP/Postal Code
45331
Country
United States
Facility Name
Wayne Hospital
City
Greenville
State/Province
Ohio
ZIP/Postal Code
45331
Country
United States
Facility Name
Greater Dayton Cancer Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Dayton Physicians LLC-Signal Point
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Dayton Physicians LLC-Wilson
City
Sidney
State/Province
Ohio
ZIP/Postal Code
45365
Country
United States
Facility Name
Springfield Regional Cancer Center
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45504
Country
United States
Facility Name
Springfield Regional Medical Center
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Facility Name
Dayton Physicians LLC - Troy
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373
Country
United States
Facility Name
Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Saint Charles Health System
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Clackamas Radiation Oncology Center
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Providence Cancer Institute Clackamas Clinic
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Bay Area Hospital
City
Coos Bay
State/Province
Oregon
ZIP/Postal Code
97420
Country
United States
Facility Name
Providence Newberg Medical Center
City
Newberg
State/Province
Oregon
ZIP/Postal Code
97132
Country
United States
Facility Name
Providence Willamette Falls Medical Center
City
Oregon City
State/Province
Oregon
ZIP/Postal Code
97045
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Providence Saint Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Penn State Health Saint Joseph Medical Center
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19605
Country
United States
Facility Name
Sanford Cancer Center Oncology Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Sanford USD Medical Center - Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5134
Country
United States
Facility Name
Baptist Memorial Hospital and Cancer Center-Collierville
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38017
Country
United States
Facility Name
Baptist Memorial Hospital and Cancer Center-Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Audie L Murphy VA Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Providence Regional Cancer System-Aberdeen
City
Aberdeen
State/Province
Washington
ZIP/Postal Code
98520
Country
United States
Facility Name
PeaceHealth Saint Joseph Medical Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Providence Regional Cancer System-Centralia
City
Centralia
State/Province
Washington
ZIP/Postal Code
98531
Country
United States
Facility Name
Swedish Cancer Institute-Edmonds
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
Facility Name
Providence Regional Cancer Partnership
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Swedish Cancer Institute-Issaquah
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98029
Country
United States
Facility Name
Kadlec Clinic Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Providence Regional Cancer System-Lacey
City
Lacey
State/Province
Washington
ZIP/Postal Code
98503
Country
United States
Facility Name
PeaceHealth Saint John Medical Center
City
Longview
State/Province
Washington
ZIP/Postal Code
98632
Country
United States
Facility Name
Pacific Gynecology Specialists
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Swedish Medical Center-Ballard Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98107
Country
United States
Facility Name
Kaiser Permanente Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Swedish Medical Center-Cherry Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-5711
Country
United States
Facility Name
Swedish Medical Center-First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Providence Regional Cancer System-Shelton
City
Shelton
State/Province
Washington
ZIP/Postal Code
98584
Country
United States
Facility Name
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
MultiCare Deaconess Cancer and Blood Specialty Center - North
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
PeaceHealth Southwest Medical Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Providence Saint Mary Regional Cancer Center
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Providence Regional Cancer System-Yelm
City
Yelm
State/Province
Washington
ZIP/Postal Code
98597
Country
United States
Facility Name
Billings Clinic-Cody
City
Cody
State/Province
Wyoming
ZIP/Postal Code
82414
Country
United States
Facility Name
Welch Cancer Center
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Veliparib With or Without Radiation Therapy, Carboplatin, and Paclitaxel in Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

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