This is a multi-center, parallel group treatment, Phase 2 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced Nonsmall cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.
Name: Cobolimab
Name: Dostarlimab
Name: Docetaxel
Description: OS is defined as survival from the date of randomization to the date of death by any cause
Measure: Overall survival (OS) in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving docetaxel alone Time: Up to 44 monthsDescription: OS is defined as survival from the date of randomization to the date of death by any cause
Measure: OS in participants receiving dostarlimab + docetaxel relative to participants receiving docetaxel alone Time: Up to 44 monthsDescription: OS is defined as survival from the date of randomization to the date of death by any cause
Measure: OS in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving dostarlimab + docetaxel Time: Up to 44 monthsDescription: Confirmed ORR is defined as the proportion of participants who have achieved confirmed complete response (CR) or confirmed partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on Investigator assessment
Measure: Objective response rate (ORR) Time: Up to 44 monthsDescription: PFS is defined as the length of time until disease progression, from the time of randomization to the earliest date of assessment of disease progression based on RECIST version 1.1 by Investigator assessment or death by any cause
Measure: Progression free survival (PFS) Time: Up to 44 monthsDescription: DOR is defined as the time from first documented response (CR/PR) until the time of first documentation of disease progression based on RECIST version 1.1 by Investigator assessment or death, whichever occurs first
Measure: Duration of response (DOR) Time: Up to 44 monthsDescription: TTD in lung cancer is defined as time from randomization to meaningful deterioration on a composite endpoint of dyspnea, chest pain, and cough, from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 13 item Lung Cancer Module (EORTC QLQ LC13)
Measure: Time to deterioration (TTD) Time: Up to 44 monthsDescription: EORTC QLQ-C30 is a questionnaire used to measure health related quality of life (HRQoL) in participants with cancer.
Measure: Change from Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 item Core Module (EORTC QLQ-C30) assessment Time: Baseline (Day 1) and up to 44 monthsDescription: EORTC QLQ LC13 is a lung cancer specific questionnaire module designed to supplement the EORTC QLQ C30.
Measure: Change from Baseline in the EORTC QLQ LC13 assessment Time: Baseline (Day 1) and up to 44 monthsDescription: Blood and urine samples will be collected for the assessment of hematology, clinical chemistry, thyroid function and urinalysis lab parameters
Measure: Number of participants with clinically significant changes in hematology, clinical chemistry, thyroid function and urinalysis lab parameters Time: From consent signature (Day -28) until the 90 day post last dose follow-upDescription: Performance status will be assessed using the ECOG performance status scale. Scales range from grade 0 to 4, grade 0 denoting fully active and grade 4 completely disabled.
Measure: Number of participants with indicated Eastern Cooperative Oncology Group (ECOG) performance status Time: From consent signature (Day -28) until the 90 day post last dose follow-upDescription: 12-lead ECGs will be obtained using an ECG machine that automatically calculates and measures PR interval, QRS interval, QT interval, Corrected QT interval using the Fridericia's formula (QTcF) and Bazett's formula (QTcB) interval.
Measure: Number of participants with abnormal findings in Electrocardiogram (ECG) Parameters Time: From consent signature (Day -28) until the 90 day post last dose follow-upAllocation: Randomized
Parallel Assignment
There is one SNP
- Participant has actionable driver mutations such as epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) translocation, neurotrophic receptor tyrosine kinase (NTRK) fusions, c ros oncogene 1 (ROS1) rearrangement, or proto oncogene B raf (BRAF) V600E mutation. --- V600E ---