A Phase IIIb/IV Safety Trial of Flat Dose Nivolumab in Combination with Ipilimumab in Participants with Non-Small Cell Lung Cancer

Phase 1

• Conditions: on-Small Cell Lung Cancer; MedDRA version: 21.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: 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: EUCTR2016-002621-10-GR
• 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: 2016-10-26
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2240

Inclusion Criteria

- Signed Written Informed Consent
- Histologically confirmed Stage 4 or recurrent non-small cell lung cancer
- Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer) for cohort A, B and C
- No prior systemic anticancer therapy (including EGFR and ALK inhibitors) for cohort A, A1 and C
- Tissue or Programmed death-ligand 1 (PD-L1) results available

Cohort 1A Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) score 2 or
- Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol

Cohort C Inclusion Criteria:
- High Tumor Mutation Burden
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 1120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1120

Exclusion Criteria

- Untreated brain metastases
- An active malignancy that requires concurrent intervention
- Active, known or suspected autoimmune disease
- Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer

Study & Design

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