A GLOBAL, RANDOMIZED, PHASE 3, OPEN-LABEL STUDY OFREGN2810 (ANTI-PD-1 ANTIBODY) VERSUS PLATINUM-BASEDCHEMOTHERAPY IN FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED OR METASTATIC PD-L1 + NON-SMALL CELL LUNG CANCER

Not Applicable

• Conditions: -C349 Bronchus or lung, unspecified; Bronchus or lung, unspecified; C349

• Registration Number: PER-038-17
• Lead Sponsor: Regeneron Pharmaceuticals Inc,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-25
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Men and women ≥18 years of age
2. Patients with histologically or cytologically documented squamous or non-squamous
NSCLC with stage IIIB or stage IV disease who received no prior systemic treatment for recurrent or metastatic NSCLC
3. Archival or newly obtained formalin-fixed tumor tissue from a metastatic/recurrent site, which has not previously been irradiated
4. Tumor cells expressing PD-L1 in ≥50% of tumor cells by IHC performed by the central laboratory 5. At least 1 radiographically measureable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria (see Appendix 2). Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site.
6. ECOG performance status of ≤1

Exclusion Criteria

1. Patients who have never smoked, defined as smoking ≤100 cigarettes throughout their lives
2. Active or untreated brain metastases or compression of the spinal cord. Patients are eligible if central nervous system (CNS) metastases are adequately treated and patients have returned neurologically to baseline (except for residual signs or symptoms related to CNS treatment) for at least 2 weeks before enrollment . Patients should not be receiving (dose of immunosuppressant) treatment with corticosteroids.
3. Patients with tumors with positive results for mutations in the EGFR gene, translocations of the ALK gene, or fusions of ROS1
4. Encephalitis, meningitis or uncontrolled seizures in the year prior to informed consent
5. History of interstitial lung disease (for example, idiopathic pulmonary fibrosis, organized pneumonia) or active non-infectious pneumonitis that required doses of glucocorticoid immunosuppressants to help with its approach. A history of radiation pneumonitis is allowed in the radiation field.
6. Patients with active autoimmune disease, known or suspected, who have required systemic treatment in the last 2 years. Patients can be enrolled with vitiligo, type I diabetes mellitus, and hypothyroidism (including hypothyroidism caused by autoimmune thyroiditis) who only need hormone replacement therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified