Description:
The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant)
immunotherapy will prolong event free survival in participants with early stage non-small
cell lung cancer.
Title
- Brief Title: A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer
- Official Title: A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Resection and Adjuvant Treatment With Nivolumab or Placebo for Participants With Resectable Stage II-IIIB Non-small Cell Lung Cancer
Clinical Trial IDs
- ORG STUDY ID:
CA209-77T
- SECONDARY ID:
2019-000262-38
- NCT ID:
NCT04025879
Conditions
- Carcinoma, Non-Small-Cell Lung
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | Opdivo, BMS936558 | Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo |
Carboplatin | | Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo |
Cisplatin | | Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo |
Paclitaxel | | Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo |
Pemetrexed | | Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo |
Placebo | | Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac. |
Docetaxel | | Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo |
Purpose
The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant)
immunotherapy will prolong event free survival in participants with early stage non-small
cell lung cancer.
Trial Arms
Name | Type | Description | Interventions |
---|
Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo | Experimental | | - Nivolumab
- Carboplatin
- Cisplatin
- Paclitaxel
- Pemetrexed
- Docetaxel
|
Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac. | Placebo Comparator | | - Carboplatin
- Cisplatin
- Paclitaxel
- Pemetrexed
- Placebo
- Docetaxel
|
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Participants with suspected or histologically confirmed Stage IIA (> 4 cm) to IIIB
(T3N2) non-small cell lung carcinoma (NSCLC) with disease that is considered
resectable
- No brain metastasis
- Treatment-naive for NSCLC (no prior systemic anti-cancer treatment)
- Ability to provide surgical or biopsy tumor tissue for biomarkers
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
Exclusion Criteria:
- Participants with an active, known or suspected autoimmune disease
- Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency
virus (HIV)
- Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents,
or radiotherapy for NSCLC
- Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody,
or any other antibody or drug specifically targeting T-cell co-stimulation or
checkpoint pathways
Other protocol-defined inclusion/exclusion criteria apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Event-Free Survival (EFS) as Assessed by Blinded Independent Central Review (BICR) |
Time Frame: | 5 Years from randomization |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall Survival (OS) |
Time Frame: | Up to 5 years from randomization |
Safety Issue: | |
Description: | |
Measure: | Pathologic Complete Response (pCR) Rate as Assessed by Blinded Independent Pathology Review (BIPR) |
Time Frame: | At the time of surgery, between week 12 to week 18 |
Safety Issue: | |
Description: | |
Measure: | Major Pathological Response (MPR) Rate as Assessed by Blinded Independent Pathology Review |
Time Frame: | Up to 8 weeks following completion of neoadjuvant surgery, approximately study week 22 |
Safety Issue: | |
Description: | |
Measure: | Incidence of Serious Adverse Events (SAEs) |
Time Frame: | Up to 80 weeks |
Safety Issue: | |
Description: | |
Measure: | Incidence of Adverse Events (AEs) |
Time Frame: | Up to 80 weeks |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
August 25, 2021