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

Phase 1

• Conditions: on-Small Cell Lung Cancer with ctDNA detected Minimal Residual Disease after Surgical Resection; MedDRA version: 20.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003719-23-FR
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-26
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 340

Inclusion 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

Exclusion Criteria prior to Surgery:
- Participants with known EGFR mutations which are sensitive to available targeted inhibitor therapy
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified