2024-515051-38-00
Completed
Phase 3
A Two-Part Randomized, Phase 3 Study of Combinations of Cemiplimab (Anti- PD-1 Antibody) and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients with Advanced or Metastatic Non-Small Cell Lung Cancer
Regeneron Pharmaceuticals Inc.16 sites in 4 countries117 target enrollmentStarted: September 26, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Regeneron Pharmaceuticals Inc.
- Enrollment
- 117
- Locations
- 16
- Primary Endpoint
- Overall survival
Overview
Brief Summary
Part 1: To compare the overall survival (OS) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC) with tumors expressing PD-L1 in <50% of tumor cells.
Part 2: To compare the OS of cemiplimab/chemo-f with placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with histologically or cytologically documented squamous or non-squamous NSCLC with stage IIIB or IIIC disease who are not candidates for treatment with definitive concurrent chemoradiation or patients with stage IV disease if they have not received prior systemic treatment for recurrent or metastatic NSCLC
- •Availability of an archival (≤5 months) or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample from a metastatic or recurrent site, which has not previously been irradiated
- •Part 1 only: Expression of PD-L1 in <50% of tumor cells determined by a commercially available assay performed by the central laboratory
- •At least 1 radiographically measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- •Anticipated life expectancy of at least 3 months
- •Note: Other protocol defined Inclusion criteria may apply
Exclusion Criteria
- •Part 1 only: Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime
- •Active or untreated brain metastases or spinal cord compression
- •Patients with tumors tested positive for Epidermal growth factor receptor (EGFR) gene mutations, Anaplastic lymphoma kinase (ALK) gene translocations, or C-ros oncogene receptor tyrosine kinase(ROS1) fusions
- •Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrolment
- •History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years
- •Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk of immune-related treatment-emergent adverse events (irTEAEs)
- •Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization
- •Note: Other protocol defined Exclusion criteria may apply
Outcomes
Primary Outcomes
Overall survival
Overall survival
Secondary Outcomes
- Progression-free survival
- Objective response rate
- Duration of Response (DOR)
- Best overall response (BOR)
- Incidence of Treatment-emergent adverse events (TEAEs)
- Part 1 only: Incidence of Dose-limiting toxicities (DLTs)
- Incidence of serious adverse events (SAEs)
- Incidence of deaths
- Incidence of laboratory abnormalities
- Overall survival rate
- Quality of life as measured by EORTC QLQ-C30
- Quality of life as measured by EORTC QLQ-LC13
Investigators
Medical Affairs
Scientific
Regeneron Pharmaceuticals Inc.
Study Sites (16)
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