Non-Small Cell Lung Cancer
Conditions
Sponsors
Regeneron Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women =18 years of age. 2. 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. The histologic diagnosis of NSCLC may be confirmed by a central laboratory. 3. Availability of an archival (=5 months) or on-study obtained formalin-fixed, paraffinembedded tumour tissue sample from a metastatic/recurrent site, which has not previously been irradiated. 4.Part 1 only: Expression of PD-L1 in =65 years) yes F.1.3.1 Number of subjects for this age range 225
Exclusion criteria
Exclusion criteria: 1. Part 1 only:Patients who have never smoked, defined as smoking =100 cigarettes in a lifetime. 2. Active or untreated brain metastases or spinal cord compression. Patients are eligible if central nervous system (CNS) metastases are adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrolment. Patients must be off (immunosuppressive doses of) corticosteroid therapy (see exclusion criteria 7) for details on timing of discontinuation of steroids). 3. Patients with tumours tested positive for EGFR gene mutations, ALK gene translocations, or ROS1 fusions. All patients will have tumour evaluated for EGFR mutations, ALK rearrangement, and ROS1 fusions confirmed by a central laboratory. 4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment. 5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organising pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved =6months prior to enrolment. 6. 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). The following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment. 7. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomisation. Physiologic replacement doses are allowed even if they are >10 mg of prednisone/day or equivalent, as long as they are not being administered for immunosuppressive intent. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: The key secondary objectives are: Part 1: To compare the progression-free survival (PFS) and objective response rate (ORR) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus chemo-f in the first line treatment of patients with advanced squamous or non-squamous NSCLC and tumors expressing PD-L1 in <50% of tumor cells. Part 2: To compare the PFS and ORR of cemiplimab/chemo-f versus placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression. Additional secondary objectives defined in the protocol.;Primary end point(s): Overall Survival (OS);Timepoint(s) of evaluation of this end point: Up to 32 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression-free survival up to 32 months Obhjective response rate up to 32 months Duration of Response (DOR) up to 32 months Best Overall Response (BOR) up to 32 months Incidence of Treatment-emergent adverse events (TEAEs) up to 32 months Incidence of Dose-limiting toxicities (DLTs) (Part 1 only) up to 32 months Incidence of serious adverse events (SAEs) up to 32 months Incidence of deaths up to 32 months Incidence of laboratory abnormalities up to 32 months Overall survival rate at 12 months Overall survival rate at 18 months Overall survival rate at 24 months Quality of Life as measured by EORTC QLQ-C30 up to 32 months Quality of Life as measured by EORTC QLQ-LC13 up to 32 months;Timepoint(s) of evaluation of this end point: See above | — |
Countries
Austria, Belgium, Canada, Croatia, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Netherlands, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Regeneron Pharmaceuticals, Inc.
Outcome results
None listed