West Cancer Center

LUNG: Metastatic: Phase 1: 2nd line or later: FRACTION-LUNG

A phase 2, fast real-time assessment of combination therapies in immune-oncology study in subjects with advanced non-small cell lung cancer (FRACTION-LUNG)

Title

Bristol-Myers Squibb CA018001A

Study Title

A phase 2, fast real-time assessment of combination therapies in immune-oncology study in subjects with advanced non-small cell lung cancer (FRACTION-LUNG)

Site Link

NCT02750514

Malignancy

Lung, Non-small cell lung cancer, NSCLC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd line or later

Investigational Agent

nivolumab with either ipilimumab, dasatanib, LAG-3 inhibitor, IDO inhibitor, or others

Drug Class

CTLA-4 antibody anti-LAG-3 antibody, IDO inhibitor, multi-kinase inhibitor, PD-1 antibody

Ari VanderWalde, MD

Sponsor

Bristol-Myers Squibb

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

NCT02750514

Key Eligibility Criteria Details

Metastatic Non-small cell lung cancer
At least 1 prior line of therapy (2nd line or later)
- Current arms require patients to be PD-1 naive (this will change)
Patients with EGFR or ALK alterations must have received targeted therapy
Measurable disease
Palliative XRT must be completed at least 2 weeks prior to enrollment
Biopsies required pre-treatment, on-treatment, and at progression
No active CNS mets
No prior malignancy unless CRR achieved at least 2 years prior and no active therapy required
No systemic therapy within 4 weeks of enrollment
No active autoimmune disease (except skin disorders, hypothyroidism, T1DM)
No severe toxicity due to prior immune therapy
No symptomatic interstitial lung disease
No known HIV/HBV/HCV

Objective

Primary- ORR, DOR, PFSR; Secondary- Safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Any

Dosing Frequency

Control Agents

Study Protocol

Randomized