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

NCT03770299 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: CA209-9TN2018-003719-23
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-Small Cell Lung Cancer; Non-Small-Cell Lung Carcinoma; Circulating Tumor DNA

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  Approximately 24 months

Secondary Outcomes (5)

• 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

Study Arms (2)

Arm A

EXPERIMENTAL

Nivolumab + SOC (chemotherapy in eligible participants or observation)

Biological: Nivolumab; Drug: Vinorelbine; Drug: Gemcitabine; Drug: Docetaxel; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Other: Observation

Arm B

ACTIVE COMPARATOR

SOC (chemotherapy in eligible participants or observation)

Drug: Vinorelbine; Drug: Gemcitabine; Drug: Docetaxel; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Other: Observation

Interventions

Nivolumab BIOLOGICAL

Specified dose on specified days

Arm A

Vinorelbine DRUG

Specified dose on specified days

Arm A; Arm B

Gemcitabine DRUG

Specified dose on specified days

Arm A; Arm B

Docetaxel DRUG

Specified dose on specified days

Arm A; Arm B

Pemetrexed DRUG

Specified dose on specified days

Arm A; Arm B

Cisplatin DRUG

Specified dose on specified days

Arm A; Arm B

Carboplatin DRUG

Specified dose on specified days

Arm A; Arm B

Paclitaxel DRUG

Specified dose on specified days

Arm A; Arm B

Observation OTHER

Observation by the investigator

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• Must have no evidence of metastatic disease after surgery
• Received a live/attenuated vaccine within 30 days of first treatment

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab; Vinorelbine; Gemcitabine; Docetaxel; Pemetrexed; Cisplatin; Carboplatin; Paclitaxel; Observation

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Methods; Investigative Techniques

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 10, 2018
• Study Start: January 15, 2021
• Primary Completion: March 14, 2023
• Study Completion: March 14, 2024
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share