A Study of Ramucirumab (LY3009806) in Combination With Weekly Docetaxel in Participants With Stage IV Non-Small Cell Lung Cancer
Primary Purpose
Stage IV Non-small Cell Lung Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ramucirumab
Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Stage IV Non-small Cell Lung Cancer focused on measuring metastatic
Eligibility Criteria
Inclusion Criteria:
- The participant had disease progression on or after prior platinum-based chemotherapy regimen for locally advanced or metastatic NSCLC.
- Prior immunotherapy for NSCLC is allowed.
- The participant has an Eastern Cooperative Oncology Group performance status of 0 or 1.
- The participant has histologically or cytologically confirmed NSCLC.
- The participant has metastatic NSCLC disease (Stage IV) at the time of first dose of study treatment.
- The participant has measurable disease at the time of first dose of study treatment documented by computed tomography (CT) scan or magnetic resonance imaging (MRI).
- The participant has resolution to Grade ≤1 by the National Cancer Institute-common terminology criteria for adverse events (NCI-CTCAE), Version 4.0, of all clinically significant toxic effects of prior locoregional therapy, surgery, or other anticancer therapy.
- The participant has adequate organ function.
- The participant's urine protein is <2+ on dipstick or routine urinalysis (UA). If urine dipstick or routine analysis indicates proteinuria ≥2+, then a 24-hour urine must be collected and must demonstrate <2 grams of protein in 24 hours to allow participation in the study.
- For male participants, are sterile (including vasectomy confirmed by post vasectomy semen analysis) or agree to use a highly effective method of contraception (2 methods preferred, or per country requirements, whichever is more strict), and to not donate sperm starting with the first dose of study treatment, during the study, and for at least 6 months following the last dose of study treatment or country requirements, whichever is longer.
- For female participants, are surgically sterile, postmenopausal, or agree to use a highly effective method of contraception (2 methods preferred, or per country requirements, whichever is more strict) during the study and for 6 months following the last dose of study treatment or country requirements, whichever is longer.
- Female participants of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to first dose of study treatment.
- The participant has a life expectancy of ≥3 months.
Exclusion Criteria:
- Prior therapy with docetaxel or ramucirumab.
- The participant has received more than 1 prior chemotherapy regimen for locally advanced or metastatic NSCLC; however, prior maintenance chemotherapy for locally advanced or metastatic NSCLC is allowed.
- The participant's tumour contains small cell lung cancer.
- The participant has undergone major surgery within 28 days prior to first dose of study treatment, or subcutaneous venous access device placement within 7 days prior to first dose of study treatment. Furthermore, any participant with postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months will be excluded.
- The participant has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
- The participant has peripheral neuropathy Grade ≥2 (NCI-CTCAE v 4.0).
- The participant has an elective or a planned major surgery during the course of the trial.
- The participant is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, chemoembolization, or targeted therapy.
- The participant has symptomatic, active, or untreated central nervous system (CNS) metastases. Brain metastases that are asymptomatic, stable and not requiring steroid use, and previously treated by radiation are allowed. The participant may have no evidence of Grade ≥1 CNS hemorrhage based on pretreatment MRI or I.V. contrast CT scan (performed within 21 days before first dose of study treatment).
- The participant has radiologically documented evidence of major blood vessel invasion or encasement by cancer.
- The participant has radiographic evidence of intratumor cavitation, regardless of tumor histology.
- The participant has a history of uncontrolled hereditary or acquired thrombotic disorder.
- The participant is receiving chronic therapy with nonsteroidal anti-inflammatory drugs (NSAIDs; for example, indomethacin, ibuprofen, naproxen, or similar agents) or other antiplatelet agents (for example, clopidogrel, ticlopidine, dipyridamole, and anagrelide). Aspirin (acetylsalicylic acid) use at doses up to 325 milligrams/day is permitted.
- Participants with a history of gross hemoptysis (defined as bright red blood or ≥1/2 teaspoon) within 2 months prior to first dose of study treatment.
- The participant has clinically relevant congestive heart failure (New York Heart Association Class II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
- The participant has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to first dose of study treatment.
- The participant has uncontrolled arterial hypertension ≥150 / ≥90 millimeters of mercury despite standard medical management.
- The participant has had a serious or nonhealing wound, ulcer, or bone fracture ≤28 days prior to first dose of study treatment.
- The participant has significant bleeding disorders, vasculitis, or experienced Grade 3-4 gastrointestinal (GI) bleeding within 3 months prior to first dose of study treatment.
- History of GI perforation and / or fistulae within 6 months prior to first dose of study treatment.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ramucirumab + Docetaxel
Arm Description
Ramucirumab given intravenously (IV) on day 1 every 3 weeks followed by weekly IV infusion of docetaxel on days 1, 8, and 15 every 4 weeks.
Outcomes
Primary Outcome Measures
Percentage of Participants with Grade ≥3 Neutropenia
Secondary Outcome Measures
Rate of Febrile Neutropenia
Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response
Progression Free Survival (PFS)
Overall Survival (OS)
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02831491
Brief Title
A Study of Ramucirumab (LY3009806) in Combination With Weekly Docetaxel in Participants With Stage IV Non-Small Cell Lung Cancer
Official Title
A Single-Arm, Phase 2 Study of Ramucirumab in Combination With Weekly Docetaxel in Patients With Stage IV Non-Small Cell Lung Cancer Following Disease Progression After Prior Platinum-Based Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Withdrawn
Why Stopped
To pursue broader program objectives in oncology.
Study Start Date
November 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to evaluate the safety of the study drug ramucirumab in combination with weekly docetaxel in participants with stage IV non-small cell lung cancer (NSCLC) following disease progression after prior platinum-based chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Non-small Cell Lung Cancer
Keywords
metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ramucirumab + Docetaxel
Arm Type
Experimental
Arm Description
Ramucirumab given intravenously (IV) on day 1 every 3 weeks followed by weekly IV infusion of docetaxel on days 1, 8, and 15 every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Ramucirumab
Other Intervention Name(s)
LY3009806
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Administered IV
Primary Outcome Measure Information:
Title
Percentage of Participants with Grade ≥3 Neutropenia
Time Frame
Baseline through End of Study (Approximately 20 Months)
Secondary Outcome Measure Information:
Title
Rate of Febrile Neutropenia
Time Frame
Baseline through End of Study (Approximately 20 Months)
Title
Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response
Time Frame
Baseline to Objective Progression or Start of New Anti-Cancer Therapy (Approximately 20 Months)
Title
Progression Free Survival (PFS)
Time Frame
Baseline to Objective Progression or Death from Any Cause (Approximately 20 Months)
Title
Overall Survival (OS)
Time Frame
Baseline to Date of Death Due to Any Cause (Approximately 20 Months)
Title
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
Time Frame
Baseline through End of Study (Approximately 20 Months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The participant had disease progression on or after prior platinum-based chemotherapy regimen for locally advanced or metastatic NSCLC.
Prior immunotherapy for NSCLC is allowed.
The participant has an Eastern Cooperative Oncology Group performance status of 0 or 1.
The participant has histologically or cytologically confirmed NSCLC.
The participant has metastatic NSCLC disease (Stage IV) at the time of first dose of study treatment.
The participant has measurable disease at the time of first dose of study treatment documented by computed tomography (CT) scan or magnetic resonance imaging (MRI).
The participant has resolution to Grade ≤1 by the National Cancer Institute-common terminology criteria for adverse events (NCI-CTCAE), Version 4.0, of all clinically significant toxic effects of prior locoregional therapy, surgery, or other anticancer therapy.
The participant has adequate organ function.
The participant's urine protein is <2+ on dipstick or routine urinalysis (UA). If urine dipstick or routine analysis indicates proteinuria ≥2+, then a 24-hour urine must be collected and must demonstrate <2 grams of protein in 24 hours to allow participation in the study.
For male participants, are sterile (including vasectomy confirmed by post vasectomy semen analysis) or agree to use a highly effective method of contraception (2 methods preferred, or per country requirements, whichever is more strict), and to not donate sperm starting with the first dose of study treatment, during the study, and for at least 6 months following the last dose of study treatment or country requirements, whichever is longer.
For female participants, are surgically sterile, postmenopausal, or agree to use a highly effective method of contraception (2 methods preferred, or per country requirements, whichever is more strict) during the study and for 6 months following the last dose of study treatment or country requirements, whichever is longer.
Female participants of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to first dose of study treatment.
The participant has a life expectancy of ≥3 months.
Exclusion Criteria:
Prior therapy with docetaxel or ramucirumab.
The participant has received more than 1 prior chemotherapy regimen for locally advanced or metastatic NSCLC; however, prior maintenance chemotherapy for locally advanced or metastatic NSCLC is allowed.
The participant's tumour contains small cell lung cancer.
The participant has undergone major surgery within 28 days prior to first dose of study treatment, or subcutaneous venous access device placement within 7 days prior to first dose of study treatment. Furthermore, any participant with postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months will be excluded.
The participant has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
The participant has peripheral neuropathy Grade ≥2 (NCI-CTCAE v 4.0).
The participant has an elective or a planned major surgery during the course of the trial.
The participant is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, chemoembolization, or targeted therapy.
The participant has symptomatic, active, or untreated central nervous system (CNS) metastases. Brain metastases that are asymptomatic, stable and not requiring steroid use, and previously treated by radiation are allowed. The participant may have no evidence of Grade ≥1 CNS hemorrhage based on pretreatment MRI or I.V. contrast CT scan (performed within 21 days before first dose of study treatment).
The participant has radiologically documented evidence of major blood vessel invasion or encasement by cancer.
The participant has radiographic evidence of intratumor cavitation, regardless of tumor histology.
The participant has a history of uncontrolled hereditary or acquired thrombotic disorder.
The participant is receiving chronic therapy with nonsteroidal anti-inflammatory drugs (NSAIDs; for example, indomethacin, ibuprofen, naproxen, or similar agents) or other antiplatelet agents (for example, clopidogrel, ticlopidine, dipyridamole, and anagrelide). Aspirin (acetylsalicylic acid) use at doses up to 325 milligrams/day is permitted.
Participants with a history of gross hemoptysis (defined as bright red blood or ≥1/2 teaspoon) within 2 months prior to first dose of study treatment.
The participant has clinically relevant congestive heart failure (New York Heart Association Class II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
The participant has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to first dose of study treatment.
The participant has uncontrolled arterial hypertension ≥150 / ≥90 millimeters of mercury despite standard medical management.
The participant has had a serious or nonhealing wound, ulcer, or bone fracture ≤28 days prior to first dose of study treatment.
The participant has significant bleeding disorders, vasculitis, or experienced Grade 3-4 gastrointestinal (GI) bleeding within 3 months prior to first dose of study treatment.
History of GI perforation and / or fistulae within 6 months prior to first dose of study treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.
This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
Links:
URL
https://www.lillytrialguide.com/en-US/studies/advanced-cancer/JVDN#?postal=
Description
A Study of Ramucirumab (LY3009806) in Combination With Weekly Docetaxel in Participants With Stage IV Non-Small Cell Lung Cancer
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A Study of Ramucirumab (LY3009806) in Combination With Weekly Docetaxel in Participants With Stage IV Non-Small Cell Lung Cancer
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