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Study of TH-302 or Placebo in Combination With Pemetrexed in Patients With Non-squamous Non-small Cell Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TH-302 combination with pemetrexed
Matched placebo in combination with pemetrexed
Sponsored by
Threshold Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring TH-302, TH-CR-415, Pemetrexed, Non-small cell lung cancer, Lung cancer, Evofosfamide

Eligibility Criteria

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

Inclusion Criteria:

  • Men and women ≥ 18 years of age.
  • Histologically or cytologically confirmed stage IIIB or IV NSCLC with non-squamous histology
  • Recurrent or progressive disease after one prior platinum-based non-pemetrexed chemotherapy treatment for advanced disease with or without maintenance
  • Neoadjuvant/adjuvant cytotoxic chemotherapy initiated < 12 months prior to study randomization will be counted as one prior treatment
  • Neoadjuvant/adjuvant cytotoxic chemotherapy initiated ≥ 12 months prior to study randomization will not be counted as one prior chemotherapy treatment
  • Use of targeted agents (e.g., monoclonal antibodies or kinase inhibitors) will not be counted as a prior chemotherapy treatment
  • Patients with known EGFR-activating mutations or ALK rearrangements should have received treatment with a targeted kinase inhibitor (e.g., erlotinib, crizotinib) and no longer be considered as a candidate for such treatment
  • Measurable disease according to RECIST 1.1
  • ECOG performance status 0-1
  • Resolution to Grade ≤ 1 Adverse Events, of all clinically significant toxic effects of prior therapy
  • Adequate hematologic, hepatic, cardiac, and renal function
  • Female patients of childbearing potential must have a negative serum or urine pregnancy test, whichever is considered standard by the institution

Exclusion Criteria:

  • Diagnosis of small cell carcinoma of the lung, squamous cell carcinoma of the lung or NSCLC NOS
  • Prior therapy with pemetrexed
  • Inability or unwillingness to take folic acid, vitamin B12 supplementation or corticosteroids
  • Inability to discontinue non-steroidal anti-inflammatory drugs for 5 days (long half-life) or for 2 days (short half-life, if CrCL <80 mL/min) before pemetrexed dosing and until 2 days after pemetrexed dosing

  • Leptomeningeal disease or any untreated or symptomatic brain metastases, unless the following criteria are met:

    • brain metastases are stable and have been previously treated with either whole-brain radiotherapy or gamma-knife surgery
    • steroids are currently not required and more than 14 days since last steroid treatment
  • Symptomatic pleural effusion (> CTCAE Grade 1 dyspnea) that is not amenable to drainage
  • Treatment with other systemic anticancer therapy within 4 weeks prior to the first dose of study medication
  • Treatment with full field radiation therapy within 4 weeks or limited field radiation therapy within 2 weeks prior to the first dose of study medication
  • Major surgery within 4 weeks or minor surgery within 2 weeks prior the first dose of study medication
  • Elective or a planned major surgery while on study treatment
  • Radiation therapy to greater than 25% of the bone marrow
  • Clinically significant active infection (e.g. tuberculosis, viral hepatitis, HIV)
  • Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct
  • Concurrent active malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
  • Pregnant or breast feeding
  • Patients who are taking medications that prolong QT interval and have a risk of Torsades de Pointes (Appendix F) or who have a history of long QT syndrome
  • Patients who are taking medications that are strong inducers or inhibitors of CYP3A4

Sites / Locations

  • UAB Cancer Center
  • Ironwood Cancer and Research Centers
  • California Cancer Center
  • California Cancer Center Associates
  • UCLA-Department of Medicine a Division of Hem/Onc
  • Sarcoma Oncology Research Center
  • VA Eastern Colorado Healthcare System
  • Christiana Care Health Services
  • Cancer Specialists of North Florida - CBO
  • AMPM Research
  • Research Medical Center
  • Ochsner Clinical Foundation
  • Walter Reed National Military Medical Center
  • St. Joseph Mercy Ann Arbor Cancer Center
  • Mayo Clinic in Rochester
  • Montefire-Einstein Center for Cancer Care
  • Clinical Research Alliance
  • Durham VA Medical Center
  • W.G. (Bill) Hefner VA Medical Center
  • Gabrail Cancer Center Research
  • Penn State Milton S. Hershey Medical Center
  • DORN VA Medical Center
  • Regional Cancer Care Institute at Regional Health
  • Associates in Oncology & Hematology
  • San Antonio Military Medical Center
  • Oncology Consultants
  • Millennium Oncology
  • Fpr Belvoir Community Hospital
  • Virginia Mason Medical Center
  • Hospital Na Bulovce, Department of Pneumology and Thoracic Surgery
  • General Univesity Hospital in Prague, Clinic of Oncology
  • Thomayer Hospital, Clinic of Pneumology
  • Regional Hospital T. Bta, Department of Pneumology
  • Asklepios Fachkliniken Munchen-Gaunting
  • Marien Hospital Herne
  • Charité Universitätsmedizin Berlin;
  • Klinikum Frankfurt Höchst GmbH
  • Lungen Clinic Grosshandsdorf GmbH
  • Universitatsklinikum Schleswig-Holstein
  • Städtisches Klinikum München - Klinikum Bogenhausen
  • Universitätsklinikum Ulm; Zentrum für Innere Medizin
  • IASO General, Oncology Unit
  • Attikon University General Hospital
  • Department of Medical Oncology
  • University General Hospital of Patras, Oncology Unit
  • Koranyi National Institute of TBC and Pulmonology, 14th Dept of Pulmonology
  • Koranyi National Institute of TBC and Pulmonology, 6th Department of Pulmonology
  • Koranyi National Institute of TBC and Pulmonology, 8th Department of Pulmonology
  • University of Debrecen, Medical and Health Science Center, Department of Pulmonology
  • Csongrad County Hospital of Chest Diseases
  • Hetenyi Geza Hospital, Department of Oncology
  • "Mater Salutis" Hospital - Operative Unit of Oncology
  • A.O.U.S. Luigi GonzagaUniversity Hospital
  • Hospital Bellaria "Carlo Alberto Pizzardi" - Operative Unit of Oncology
  • IRCCS Azienda Ospedallera Universitaria San Martino-IST-Istituto Nazionale per la Ricerca sul Cancro
  • European Institute of Oncology (IEO) - Medical Care Unit
  • S. Gerardo Hospital - Complex Structure of Medical Oncology
  • Azienda Ospedaliera Universitaria Policlinico della Seconda Universita di Napoli
  • University Hospital of Pisa, Department of Cardothoracic Surgery, Operative unit of Pneumology
  • "Santa Maria degli Angeli" - Hospital - Complex Operative Unit of Oncology
  • San Camillo-Forlanini Hospital - U.O.C. Pneumologia Oncologica 1
  • Med-Polonia Sp. z o.o.
  • L. Rydygier Provencial Hospitals in Torun, Dept. of Tumors Chemotherapy
  • Maria Sklodowska-Curie Institute of Oncology in Warsaw
  • Oncology Centre "Sf. Nectarie"
  • Pro. Dr. Alex Trestioreanu Institute of Oncology
  • Prof. Dr. Ioan Chiricuta Institute of Oncology
  • Republican Clinical Oncology Center under the Ministry of Healthcare of Tatarstan Republic
  • Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of Medical Sciences
  • Blokhin Russian Oncology Research Center
  • State Healthcare Institution: Nizhny Novgorod Regional Oncology Center
  • St. Petersburg Clinical Center for Applied Special Medical Services (Oncology)
  • St. Petersburg 1st State Medical University n.a.I.P. Pavlov under the Ministry of Healthcare of the Russian Federation
  • City Clinical Oncology Center, Oncology Department (Thoracic Oncology)
  • General University Hospital Gregorio Maranon, Dept. of Oncology
  • Jimenez Diaz Foundation
  • Hospital Universitario Puerta de Hierro
  • University Hospital Virgen de Valme
  • Dr. Peset University Hospital, Dept. of Oncology
  • Hospital Universitario La Fe, Servicio de Oncologia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TH-302 and pemetrexed

Placebo and pemetrexed

Arm Description

TH-302 in combination with pemetrexed

Matching placebo in combination with pemetrexed

Outcomes

Primary Outcome Measures

Overall Survival
To assess the efficacy of pemetrexed in combination with TH-302 as determined by overall survival in patients with advanced non-squamous NSCLC in the second-line chemotherapy setting compared with pemetrexed in combination with placebo

Secondary Outcome Measures

Full Information

First Posted
March 18, 2014
Last Updated
March 23, 2021
Sponsor
Threshold Pharmaceuticals
Collaborators
EMD Serono
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1. Study Identification

Unique Protocol Identification Number
NCT02093962
Brief Title
Study of TH-302 or Placebo in Combination With Pemetrexed in Patients With Non-squamous Non-small Cell Lung Cancer
Official Title
A Randomized Phase 2, Double-blind, Placebo-controlled, Multi-center Study Comparing Pemetrexed in Combination With TH-302 vs. Pemetrexed in Combination With Placebo as Second-line Chemotherapy for Advanced Non-Squamous, Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
At the interim analysis, the futility boundary was not met and the study was stopped due to insufficient efficacy.
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Threshold Pharmaceuticals
Collaborators
EMD Serono

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether TH-302 in combination with pemetrexed is safe and effective in the treatment of non-squamous non-small cell lung cancer.
Detailed Description
TH-302 is designed to target the hypoxic regions of tumors which are generally located distant from tumor vessels. Pemetrexed has poor tissue penetration and targets the regions of tumors that are located in proximity to the tumor vessels. The presence of hypoxia in solid tumors is associated with a more malignant phenotype and resistance to chemotherapy. The hypoxia-activated prodrug, TH-302, is designed to selectively target the hypoxic microenvironment. There is evidence supporting the presence of hypoxia in NSCLC lesions based on a hypoxia PET study. Combining pemetrexed with TH-302 may enable the targeting of both the normoxic and hypoxic regions of NSCLC lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
TH-302, TH-CR-415, Pemetrexed, Non-small cell lung cancer, Lung cancer, Evofosfamide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TH-302 and pemetrexed
Arm Type
Experimental
Arm Description
TH-302 in combination with pemetrexed
Arm Title
Placebo and pemetrexed
Arm Type
Active Comparator
Arm Description
Matching placebo in combination with pemetrexed
Intervention Type
Drug
Intervention Name(s)
TH-302 combination with pemetrexed
Intervention Description
400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle. Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration.
Intervention Type
Drug
Intervention Name(s)
Matched placebo in combination with pemetrexed
Intervention Description
Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle. Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration.
Primary Outcome Measure Information:
Title
Overall Survival
Description
To assess the efficacy of pemetrexed in combination with TH-302 as determined by overall survival in patients with advanced non-squamous NSCLC in the second-line chemotherapy setting compared with pemetrexed in combination with placebo
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women ≥ 18 years of age. Histologically or cytologically confirmed stage IIIB or IV NSCLC with non-squamous histology Recurrent or progressive disease after one prior platinum-based non-pemetrexed chemotherapy treatment for advanced disease with or without maintenance Neoadjuvant/adjuvant cytotoxic chemotherapy initiated < 12 months prior to study randomization will be counted as one prior treatment Neoadjuvant/adjuvant cytotoxic chemotherapy initiated ≥ 12 months prior to study randomization will not be counted as one prior chemotherapy treatment Use of targeted agents (e.g., monoclonal antibodies or kinase inhibitors) will not be counted as a prior chemotherapy treatment Patients with known EGFR-activating mutations or ALK rearrangements should have received treatment with a targeted kinase inhibitor (e.g., erlotinib, crizotinib) and no longer be considered as a candidate for such treatment Measurable disease according to RECIST 1.1 ECOG performance status 0-1 Resolution to Grade ≤ 1 Adverse Events, of all clinically significant toxic effects of prior therapy Adequate hematologic, hepatic, cardiac, and renal function Female patients of childbearing potential must have a negative serum or urine pregnancy test, whichever is considered standard by the institution Exclusion Criteria: Diagnosis of small cell carcinoma of the lung, squamous cell carcinoma of the lung or NSCLC NOS Prior therapy with pemetrexed Inability or unwillingness to take folic acid, vitamin B12 supplementation or corticosteroids Inability to discontinue non-steroidal anti-inflammatory drugs for 5 days (long half-life) or for 2 days (short half-life, if CrCL <80 mL/min) before pemetrexed dosing and until 2 days after pemetrexed dosing Leptomeningeal disease or any untreated or symptomatic brain metastases, unless the following criteria are met: brain metastases are stable and have been previously treated with either whole-brain radiotherapy or gamma-knife surgery steroids are currently not required and more than 14 days since last steroid treatment Symptomatic pleural effusion (> CTCAE Grade 1 dyspnea) that is not amenable to drainage Treatment with other systemic anticancer therapy within 4 weeks prior to the first dose of study medication Treatment with full field radiation therapy within 4 weeks or limited field radiation therapy within 2 weeks prior to the first dose of study medication Major surgery within 4 weeks or minor surgery within 2 weeks prior the first dose of study medication Elective or a planned major surgery while on study treatment Radiation therapy to greater than 25% of the bone marrow Clinically significant active infection (e.g. tuberculosis, viral hepatitis, HIV) Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct Concurrent active malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin or pre-invasive carcinoma of the cervix. Pregnant or breast feeding Patients who are taking medications that prolong QT interval and have a risk of Torsades de Pointes (Appendix F) or who have a history of long QT syndrome Patients who are taking medications that are strong inducers or inhibitors of CYP3A4
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tillman Pearce, MD
Organizational Affiliation
Threshold Pharmaceuticals
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jonathan Goldman, MD
Organizational Affiliation
UCLA-Dept of Medicine a Div of Hem/Onc
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Ironwood Cancer and Research Centers
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
California Cancer Center
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
California Cancer Center Associates
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
UCLA-Department of Medicine a Division of Hem/Onc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Sarcoma Oncology Research Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
VA Eastern Colorado Healthcare System
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Cancer Specialists of North Florida - CBO
City
Jacksonville Beach
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
AMPM Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
64132
Country
United States
Facility Name
Ochsner Clinical Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
St. Joseph Mercy Ann Arbor Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Montefire-Einstein Center for Cancer Care
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Clinical Research Alliance
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Durham VA Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
W.G. (Bill) Hefner VA Medical Center
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
DORN VA Medical Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29209
Country
United States
Facility Name
Regional Cancer Care Institute at Regional Health
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Associates in Oncology & Hematology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
San Antonio Military Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Oncology Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Millennium Oncology
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Fpr Belvoir Community Hospital
City
Fort Belvoir
State/Province
Virginia
ZIP/Postal Code
22060
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Hospital Na Bulovce, Department of Pneumology and Thoracic Surgery
City
Liben
ZIP/Postal Code
18081
Country
Czechia
Facility Name
General Univesity Hospital in Prague, Clinic of Oncology
City
Prague
ZIP/Postal Code
12800
Country
Czechia
Facility Name
Thomayer Hospital, Clinic of Pneumology
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Regional Hospital T. Bta, Department of Pneumology
City
Zlin
ZIP/Postal Code
76275
Country
Czechia
Facility Name
Asklepios Fachkliniken Munchen-Gaunting
City
Gauting
State/Province
Bavaria
ZIP/Postal Code
82131
Country
Germany
Facility Name
Marien Hospital Herne
City
Herne
State/Province
North Rhine-Westphalia
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin;
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Klinikum Frankfurt Höchst GmbH
City
Frankfurt
ZIP/Postal Code
65929
Country
Germany
Facility Name
Lungen Clinic Grosshandsdorf GmbH
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein
City
Lubeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Städtisches Klinikum München - Klinikum Bogenhausen
City
München
ZIP/Postal Code
81925
Country
Germany
Facility Name
Universitätsklinikum Ulm; Zentrum für Innere Medizin
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
IASO General, Oncology Unit
City
Athens
ZIP/Postal Code
15562
Country
Greece
Facility Name
Attikon University General Hospital
City
Athens
Country
Greece
Facility Name
Department of Medical Oncology
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
University General Hospital of Patras, Oncology Unit
City
Patras
ZIP/Postal Code
26500
Country
Greece
Facility Name
Koranyi National Institute of TBC and Pulmonology, 14th Dept of Pulmonology
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Koranyi National Institute of TBC and Pulmonology, 6th Department of Pulmonology
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Koranyi National Institute of TBC and Pulmonology, 8th Department of Pulmonology
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
University of Debrecen, Medical and Health Science Center, Department of Pulmonology
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Csongrad County Hospital of Chest Diseases
City
Deszk
ZIP/Postal Code
6772
Country
Hungary
Facility Name
Hetenyi Geza Hospital, Department of Oncology
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
"Mater Salutis" Hospital - Operative Unit of Oncology
City
Verona
State/Province
Legnago
ZIP/Postal Code
37045
Country
Italy
Facility Name
A.O.U.S. Luigi GonzagaUniversity Hospital
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
Hospital Bellaria "Carlo Alberto Pizzardi" - Operative Unit of Oncology
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
IRCCS Azienda Ospedallera Universitaria San Martino-IST-Istituto Nazionale per la Ricerca sul Cancro
City
Genova
Country
Italy
Facility Name
European Institute of Oncology (IEO) - Medical Care Unit
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
S. Gerardo Hospital - Complex Structure of Medical Oncology
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico della Seconda Universita di Napoli
City
Napoli
Country
Italy
Facility Name
University Hospital of Pisa, Department of Cardothoracic Surgery, Operative unit of Pneumology
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
"Santa Maria degli Angeli" - Hospital - Complex Operative Unit of Oncology
City
Pordenone
ZIP/Postal Code
33170
Country
Italy
Facility Name
San Camillo-Forlanini Hospital - U.O.C. Pneumologia Oncologica 1
City
Rome
ZIP/Postal Code
00152
Country
Italy
Facility Name
Med-Polonia Sp. z o.o.
City
Poznan
ZIP/Postal Code
60693
Country
Poland
Facility Name
L. Rydygier Provencial Hospitals in Torun, Dept. of Tumors Chemotherapy
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Maria Sklodowska-Curie Institute of Oncology in Warsaw
City
Warsaw
ZIP/Postal Code
02781
Country
Poland
Facility Name
Oncology Centre "Sf. Nectarie"
City
Craiova
State/Province
Dolj County
Country
Romania
Facility Name
Pro. Dr. Alex Trestioreanu Institute of Oncology
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Prof. Dr. Ioan Chiricuta Institute of Oncology
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Republican Clinical Oncology Center under the Ministry of Healthcare of Tatarstan Republic
City
Kazan
State/Province
Republic Of Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of Medical Sciences
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Blokhin Russian Oncology Research Center
City
Moscow
ZIP/Postal Code
15478
Country
Russian Federation
Facility Name
State Healthcare Institution: Nizhny Novgorod Regional Oncology Center
City
Nizhny Novgorod
ZIP/Postal Code
603081
Country
Russian Federation
Facility Name
St. Petersburg Clinical Center for Applied Special Medical Services (Oncology)
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
St. Petersburg 1st State Medical University n.a.I.P. Pavlov under the Ministry of Healthcare of the Russian Federation
City
St. Petersburg
ZIP/Postal Code
197101
Country
Russian Federation
Facility Name
City Clinical Oncology Center, Oncology Department (Thoracic Oncology)
City
St. Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
General University Hospital Gregorio Maranon, Dept. of Oncology
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Jimenez Diaz Foundation
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
University Hospital Virgen de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Dr. Peset University Hospital, Dept. of Oncology
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hospital Universitario La Fe, Servicio de Oncologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Study of TH-302 or Placebo in Combination With Pemetrexed in Patients With Non-squamous Non-small Cell Lung Cancer

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