Description:
The purpose of this study is to determine if nivolumab added to the standard of care therapy
(SOC) given after surgery is more effective than SOC alone in prolonging disease free
survival in NSCLC participants with minimal residual disease detected after surgery.
Title
- Brief Title: An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease
- Official Title: A Phase 2 Multi-Center Randomized Trial to Assess Early Intervention With Adjuvant Nivolumab in Non-Small Cell Lung Cancer Participants With ctDNA-detected Minimal Residual Disease After Surgical Resection
Clinical Trial IDs
- ORG STUDY ID:
CA209-9TN
- SECONDARY ID:
2018-003719-23
- NCT ID:
NCT03770299
Conditions
- Non-Small Cell Lung Cancer
- Non-Small-Cell Lung Carcinoma
- Circulating Tumor DNA
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | | Arm A |
Vinorelbine | | Arm A |
Gemcitabine | | Arm A |
Docetaxel | | Arm A |
Pemetrexed | | Arm A |
Cisplatin | | Arm A |
Carboplatin | | Arm A |
Paclitaxel | | Arm A |
Purpose
The purpose of this study is to determine if nivolumab added to the standard of care therapy
(SOC) given after surgery is more effective than SOC alone in prolonging disease free
survival in NSCLC participants with minimal residual disease detected after surgery.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A | Experimental | Nivolumab + SOC (chemotherapy in eligible participants or observation) | - Nivolumab
- Vinorelbine
- Gemcitabine
- Docetaxel
- Pemetrexed
- Cisplatin
- Carboplatin
- Paclitaxel
|
Arm B | Active Comparator | SOC (chemotherapy in eligible participants or observation) | - Vinorelbine
- Gemcitabine
- Docetaxel
- Pemetrexed
- Cisplatin
- Carboplatin
- Paclitaxel
|
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria prior to Surgery:
- Suspected or histologically confirmed Stage IIA to IIIB NSCLC with disease that is
considered resectable
- Must be deemed eligible for complete resection and must agree to undergo standard of
care surgery for complete resection of NSCLC
- Treatment naive (no previous systemic treatment)
Inclusion Criteria prior to Treatment Randomization:
- Must have undergone complete surgical resection of their Stage IIA to IIIB NSCLC
- Must have adequately recovered from surgery at the time of randomization
- Minimal residual disease (MRD) positive results as detected by ctDNA
Exclusion Criteria prior to Surgery:
- Participants with known EGFR mutations which are sensitive to available targeted
inhibitor therapy (Prior to treatment randomization in select sites)
- Active, known or suspected autoimmune disease
- Participants with a condition requiring systemic treatment with either corticosteroids
(> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14
days of randomization
Exclusion Criteria prior to Treatment Randomization:
- Must continue to meet Exclusion Criteria prior to Surgery
- Must have no evidence of metastatic disease after surgery
- Received a live/attenuated vaccine within 30 days of first treatment
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: | Disease-free survival (DFS) |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Circulating tumor DNA (ctDNA) response rate |
Time Frame: | Approximately 36 months |
Safety Issue: | |
Description: | |
Measure: | ctDNA duration of response (DOR) |
Time Frame: | Approximately 36 months |
Safety Issue: | |
Description: | |
Measure: | ctDNA time to response (TTR) |
Time Frame: | Approximately 36 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of adverse events (AEs) |
Time Frame: | Approximately 36 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of serious adverse events (SAEs) |
Time Frame: | Approximately 36 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Withdrawn |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
May 28, 2020