EUCTR2018-003719-23-GB
Active, not recruiting
Phase 1
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 - CheckMate 9T
DrugsOPDIVO 10 mg/mL concentrate for solution for infusion.Vinorelbine NC 10 mg/ml – Concentrate for preparing a solution for infusionVinorelbin Aurobindo 10 mg/ml Concentrate for Solution for InfusionGEMCI-cell 38 mg/ml Concentrate for solution for infusionGemcitabine 1 g Powder for Solution for Infusion
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 340
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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:
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
Outcomes
Primary Outcomes
Not specified
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