An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease (CheckMate 9TN)

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 2

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

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03770299

CA209-9TN

2018-003719-23 (EudraCT Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm A

Experimental group

Description:

Nivolumab + SOC (chemotherapy in eligible participants or observation)

Treatment:

Drug: Carboplatin

Drug: Pemetrexed

Biological: Nivolumab

Drug: Paclitaxel

Other: Observation

Drug: Gemcitabine

Drug: Docetaxel

Drug: Cisplatin

Drug: Vinorelbine

Arm B

Active Comparator group

Description:

SOC (chemotherapy in eligible participants or observation)

Treatment:

Drug: Carboplatin

Drug: Pemetrexed

Drug: Paclitaxel

Other: Observation

Drug: Gemcitabine

Drug: Docetaxel

Drug: Cisplatin

Drug: Vinorelbine