An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-Small Cell Lung Cancer, Non-Small-Cell Lung Carcinoma, Circulating Tumor DNA

Intervention / Treatment
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* Biological: Nivolumab
* Drug: Vinorelbine
* Drug: Gemcitabine
* Drug: Docetaxel
* Drug: Pemetrexed
* Drug: Cisplatin
* Drug: Carboplatin
* Drug: Paclitaxel
* Other: Observation


Participation Criteria
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Eligibility Criteria
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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 apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Nivolumab + SOC (chemotherapy in eligible participants or observation) | Biological: Nivolumab<br>* Specified dose on specified days<br>Drug: Vinorelbine<br>* Specified dose on specified days<br>Drug: Gemcitabine<br>* Specified dose on specified days<br>Drug: Docetaxel<br>* Specified dose on specified days<br>Drug: Pemetrexed<br>* Specified dose on specified days<br>Drug: Cisplatin<br>* Specified dose on specified days<br>Drug: Carboplatin<br>* Specified dose on specified days<br>Drug: Paclitaxel<br>* Specified dose on specified days<br>Other: Observation<br>* Observation by the investigator<br>|
| Active Comparator: Arm B<br>SOC (chemotherapy in eligible participants or observation) | Drug: Vinorelbine<br>* Specified dose on specified days<br>Drug: Gemcitabine<br>* Specified dose on specified days<br>Drug: Docetaxel<br>* Specified dose on specified days<br>Drug: Pemetrexed<br>* Specified dose on specified days<br>Drug: Cisplatin<br>* Specified dose on specified days<br>Drug: Carboplatin<br>* Specified dose on specified days<br>Drug: Paclitaxel<br>* Specified dose on specified days<br>Other: Observation<br>* Observation by the investigator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival (DFS) |  | Approximately 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating tumor DNA (ctDNA) response rate |  | Approximately 36 months | 
| ctDNA duration of response (DOR) |  | Approximately 36 months | 
| ctDNA time to response (TTR) |  | Approximately 36 months | 
| Incidence of adverse events (AEs) |  | Approximately 36 months | 
| Incidence of serious adverse events (SAEs) |  | Approximately 36 months |