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

Phase 2

Withdrawn

• Conditions: Circulating Tumor DNA; Non-Small Cell Lung Cancer; Non-Small-Cell Lung Carcinoma
• Interventions: Biological: Nivolumab; Drug: Vinorelbine; Drug: Gemcitabine; Drug: Docetaxel; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Other: Observation

• Registration Number: NCT03770299
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-07
• Study First Submitted QC: 2018-12-07
• Study First Posted: 2018-12-10
• Study Start: 2021-01-15
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-24
• Primary Completion: 2023-03-14
• Study Completion: 2024-03-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Docetaxel	Nivolumab + SOC (chemotherapy in eligible participants or observation)
Arm A	Observation	Nivolumab + SOC (chemotherapy in eligible participants or observation)
Arm A	Nivolumab	Nivolumab + SOC (chemotherapy in eligible participants or observation)
Arm B	Observation	SOC (chemotherapy in eligible participants or observation)
Arm A	Gemcitabine	Nivolumab + SOC (chemotherapy in eligible participants or observation)
Arm A	Pemetrexed	Nivolumab + SOC (chemotherapy in eligible participants or observation)
Arm A	Carboplatin	Nivolumab + SOC (chemotherapy in eligible participants or observation)
Arm A	Paclitaxel	Nivolumab + SOC (chemotherapy in eligible participants or observation)
Arm A	Cisplatin	Nivolumab + SOC (chemotherapy in eligible participants or observation)
Arm A	Vinorelbine	Nivolumab + SOC (chemotherapy in eligible participants or observation)
Arm B	Gemcitabine	SOC (chemotherapy in eligible participants or observation)
Arm B	Vinorelbine	SOC (chemotherapy in eligible participants or observation)
Arm B	Docetaxel	SOC (chemotherapy in eligible participants or observation)
Arm B	Pemetrexed	SOC (chemotherapy in eligible participants or observation)
Arm B	Carboplatin	SOC (chemotherapy in eligible participants or observation)
Arm B	Cisplatin	SOC (chemotherapy in eligible participants or observation)
Arm B	Paclitaxel	SOC (chemotherapy in eligible participants or observation)

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS)	Approximately 24 months

Secondary Outcome Measures

Name	Time	Method
Incidence of serious adverse events (SAEs)	Approximately 36 months
ctDNA time to response (TTR)	Approximately 36 months
Incidence of adverse events (AEs)	Approximately 36 months
Circulating tumor DNA (ctDNA) response rate	Approximately 36 months
ctDNA duration of response (DOR)	Approximately 36 months