REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in Patients With Lung Cancer
- Conditions
- on-small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2080224136
- Lead Sponsor
- Sanofi K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- terminated
- Sex
- All
- Target Recruitment
- 585
Key Inclusion Criteria:
1. 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 chemo/radiation or patients with stage IV disease if they have not received prior systemic treatment for recurrent or metastatic NSCLC.
2. Availability of an archival or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample
3. Expression of PD-L1 in >=50% of tumor cells determined by the commercially available assay performed by the central laboratory
4. At least 1 radiographically measureable 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
5. Eastern Cooperative Oncology Group (ECOG) performance status of <=1
6. Anticipated life expectancy of at least 3 months
Key Exclusion Criteria:
1. Patients who have never smoked, defined as smoking <= 100 cigarettes in a lifetime
2. Active or untreated brain metastases or spinal cord compression
3. Patients with tumors tested positive for Epidermal growth factor receptor (EGFR) and Anaplastic lymphoma kinase (ALK) gene mutations, or C-ros oncogene receptor tyrosine kinase(ROS1) fusions
4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
5. 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
6. Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related treatment-emergent adverse events (irTEAEs)
7. Previous treatment with idelalisib at any time (ZYDELIG)
8. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>1. PFS as assessed by a blinded Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessments
- Secondary Outcome Measures
Name Time Method efficacy<br>1. Overall survival (OS)<br>efficacy<br>2. Objective response rate (ORR)<br>safety<br>3. Incidence of Treatment-emergent adverse events (TEAEs)<br>safety<br>4. Incidence of Dose-limiting toxicities (DLTs)<br>safety<br>5. Incidence of serious adverse events (SAEs)<br>safety<br>6. Incidence of deaths<br>safety<br>7. Incidence of laboratory abnormalities<br>efficacy<br>8. Quality of life (Core 30 Questionnaire) <br>As measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) four-point scale, with 1 as not at all and 4 as very much<br>efficacy<br>9. Quality of life (Lung Cancer 13 Questionnaire)<br>As measured by the Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) to assess lung cancer-associated symptoms and treatment-related side effects among lung cancer patients. The scale for EORTC-QLQ-LC13 is 1-4 for most outcome measures of systems, with 1 rated as not at all and 4 rated as very much.