Description:
This study is for participants with Non-small Cell Lung Cancer that has spread or has
reoccurred after failure of Chemotherapy and Immunotherapy
Title
- Brief Title: A Phase 1/2 Study Evaluating Multiple Nivolumab Combination Therapy in Participants With Stage IV Non-small Cell Lung Cancer That Has Spread or Has Reoccurred After Failure of Chemotherapy and Immunotherapy
- Official Title: A Phase 1/2, Randomized Study Evaluating Multiple Nivolumab Combination Therapy in Participants With Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy and Anti-PD-1 (L1) Immunotherapy
Clinical Trial IDs
- ORG STUDY ID:
CA209-79X
- NCT ID:
NCT04151563
Conditions
- Carcinoma, Non-small Cell Lung
Interventions
Drug | Synonyms | Arms |
---|
nivolumab | | Arm A: cabozantinib + nivolumab + ipilimumab |
ipilimumab | | Arm A: cabozantinib + nivolumab + ipilimumab |
cabozantinib | | Arm A: cabozantinib + nivolumab + ipilimumab |
docetaxel | | Arm C: nivolumab + ramucirumab + docetaxel |
ramucirumab | | Arm C: nivolumab + ramucirumab + docetaxel |
lucitanib | | Arm D: lucitanib + nivolumab |
Purpose
This study is for participants with Non-small Cell Lung Cancer that has spread or has
reoccurred after failure of Chemotherapy or Immunotherapy
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A: cabozantinib + nivolumab + ipilimumab | Experimental | | - nivolumab
- ipilimumab
- cabozantinib
|
Arm B: cabozantinib + nivolumab | Experimental | | |
Arm C: nivolumab + ramucirumab + docetaxel | Experimental | | - nivolumab
- docetaxel
- ramucirumab
|
Arm D: lucitanib + nivolumab | Experimental | | |
Arm E: nivolumab + docetaxel | Experimental | | |
Arm F: docetaxel | Active Comparator | | |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Stage IV non-small cell lung Cancer, stage IIIB/C disease failed concurrent chemoRT
- ECOG Performance Status of ≤ 1
- Clinically documented or radiographically documented disease progression/recurrence
during or after the last dose of treatment
- Progression on one anti-PD-1/anti-PD-L1 therapy and one platinum-based doublet regimen
given either concurrently or sequentially
- Radiographic disease progression or recurrence during or within 90 days after the last
dose of durvalumab for locally advanced disease
- All participants must have tumor tissue submitted prior to randomization, either a
recent archival sample obtained on/after the date of disease progression of the last
prior anticancer therapy and within 3 months prior to enrollment, or a fresh biopsy
obtained during the screening period.
- Toxicities must be to grade 1
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
test and must not be breastfeeding
- Males who are sexually active with WOCBP must agree to follow instructions for
method(s) of contraception. In addition, male participants must be willing to refrain
from sperm donation during this time and must agree to follow instructions for
method(s) of contraception. Azoospermic males are exempt from contraceptive
requirements as well as WOCBP who are continuously not heterosexually active, however,
a pregnancy test will still be required.
Exclusion Criteria
- Prior treatment with Docetaxel
- Active brain metastases, carcinomatous meningitis or leptomeningeal metastases
- Any tumor invading the Superior Vena Cava other blood vessel, GI Tract or Trachea
- EGFR mutations, ALK translocations, ROS1 translocations which are sensitive to
inhibitor therapy
- History of cerebrovascular accident
- Participants with interstital lung disease, history of cerebrovascular accident or
history of abdominal fistula, gastrointestinal perforation, bowel obstruction,
intra-abdominal abscess or grade 3-4 bleeding event within 6 months prior to
randomization
- Known toxicity on prior checkpoint inhibitor treatment
- Participants who received more than one line of anti- PD-1/PD-L1 treatment
- Participants who received previous CTLA-4 inhibitor treatment
- Participants with known BRAF V600E mutation which are sensitive to available targeted
inhibitor therapy are excluded
Other protocol defined inclusion/exclusion criteria could apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall Reponse Rate (ORR) |
Time Frame: | approximately 33 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall Survival (OS) |
Time Frame: | Up to 5 Years |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DOR) |
Time Frame: | approximately 33 months |
Safety Issue: | |
Description: | |
Measure: | Progression-Free Survival (PFS) |
Time Frame: | Up to 5 Years |
Safety Issue: | |
Description: | |
Measure: | Incidence of Adverse Events (AEs) |
Time Frame: | Up to 5 Years |
Safety Issue: | |
Description: | |
Measure: | Incidence of Serious Adverse Events (SAEs) |
Time Frame: | Up to 5 Years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated