Description:
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.
Title
- Brief Title: Study of Cobolimab in Combination With Dostarlimab and Docetaxel in Advanced NSCLC Participants
- Official Title: A Randomized, Open Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel To Dostarlimab + Docetaxel To Docetaxel Alone In Participants With Advanced Nonsmall Cell Lung Cancer Who Have Progressed On Prior Anti-PD-(L)1 Therapy And Chemotherapy (COSTAR Lung)
Clinical Trial IDs
- ORG STUDY ID:
213410
- SECONDARY ID:
2020-003433-37
- NCT ID:
NCT04655976
Conditions
- Lung Cancer, Non-Small Cell
Interventions
Drug | Synonyms | Arms |
---|
Cobolimab | | Participants receiving cobolimab+dostarlimab+docetaxel |
Dostarlimab | | Participants receiving cobolimab+dostarlimab+docetaxel |
Docetaxel | | Participants receiving cobolimab+dostarlimab+docetaxel |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Participants receiving cobolimab+dostarlimab+docetaxel | Experimental | | - Cobolimab
- Dostarlimab
- Docetaxel
|
Participants receiving dostarlimab+docetaxel | Experimental | | |
Participants receiving docetaxel | Active Comparator | | |
Eligibility Criteria
Inclusion Criteria:
- Participant has advanced or metastatic NSCLC, including squamous or non-squamous cell
carcinoma.
- Participant has received no more than 2 prior lines of therapy, which must include a
platinum based chemotherapy (e.g., cisplatin, carboplatin) and an anti-PD-(L)1
antibody.
- Participant has measurable disease.
- Participant has documented radiographic disease progression on prior platinum based
chemotherapy and on or after prior anti-PD-(L)1 therapy.
- Participant agrees to submit an archival tumor tissue specimen that was collected on
or after diagnosis of metastatic disease. If archival tissue is not available, the
participant must undergo biopsy prior to study entry.
- Participant has an ECOG performance status score of 0 or 1.
- Participant has a life expectancy of at least 3 months.
- Participant has adequate Baseline organ function.
- Participant has recovered from any prior treatment related toxicities.
- Participant agrees to use contraception.
Exclusion Criteria:
- Participant has been previously treated with an anti-programmed death-ligand 1
(anti-PD-[L]1) or anti-programmed death-ligand 2 (anti-PD-[L]2) agent that resulted in
permanent discontinuation due to an Adverse Event (AE).
- Participant has been previously treated with an anti-T cell immunoglobulin and mucin
domain containing 3 (anti-TIM-3) or anti-cytotoxic T lymphocyte associated protein 4
(CTLA 4) agent or docetaxel.
- 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.
- Participant had radiological or clinical disease progression (i.e., worsening
performance status, clinical symptoms, and laboratory data) <=8 weeks after initiation
of prior anti-programmed cell death protein 1 (anti-PD-1) or anti-programmed
death-ligand 1 (anti-PD-L1) antibody. The clinical disease progression should have
been confirmed by a subsequent radiological scan.
- Participant has received radiation to the lung that is >30 gray (Gy) within 6 months
prior to the first dose of study treatment.
- Participant has completed palliative radiotherapy within 7 days prior to the first
dose of study treatment.
- Participant is ineligible if any of the following hepatic characteristics are present:
a. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5*ULN
concomitant with alkaline phosphatase (ALP) >2.5*ULN; b. Bilirubin >1*ULN; c. Current
active liver or biliary disease (with the exception of Gilbert's syndrome or
asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease
per the Investigator's assessment).
- Participant has known new or progressive brain metastases and/or leptomeningeal
metastases. Participants who have received prior therapy for their brain metastases
and have radiographically stable central nervous system disease may participate,
provided they are neurologically stable for at least 4 weeks before study entry and
are off corticosteroids within 3 days prior to the first dose of study treatment.
- Participant has known human immunodeficiency virus (HIV) (positive for HIV 1 or HIV 2
antibodies).
- Participant has active autoimmune disease that required systemic treatment in the past
2 years, is immunocompromised in the opinion of the Investigator, or is receiving
systemic immunosuppressive treatment.
- Participant has symptomatic ascites or pleural effusion. A participant who is
clinically stable following treatment of these conditions (including therapeutic
thoracentesis or paracentesis) is eligible.
- Participant has current interstitial lung disease, current pneumonitis, or a history
of pneumonitis that required the use of oral or IV glucocorticoids to assist with
management.
- Participant has pre-existing peripheral neuropathy that is Grade >=2 by National
Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version
5.0 criteria.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall survival (OS) in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving docetaxel alone |
Time Frame: | Up to 44 months |
Safety Issue: | |
Description: | OS is defined as survival from the date of randomization to the date of death by any cause |
Secondary Outcome Measures
Measure: | OS in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving dostarlimab + docetaxel |
Time Frame: | Up to 44 months |
Safety Issue: | |
Description: | OS is defined as survival from the date of randomization to the date of death by any cause |
Measure: | Objective response rate (ORR) |
Time Frame: | Up to 44 months |
Safety Issue: | |
Description: | 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: | Progression free survival (PFS) |
Time Frame: | Up to 44 months |
Safety Issue: | |
Description: | 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: | Duration of response (DOR) |
Time Frame: | Up to 44 months |
Safety Issue: | |
Description: | 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: | Time to deterioration (TTD) |
Time Frame: | Up to 44 months |
Safety Issue: | |
Description: | 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: | 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 Frame: | Baseline (Day 1) and up to 44 months |
Safety Issue: | |
Description: | 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 EORTC QLQ LC13 assessment |
Time Frame: | Baseline (Day 1) and up to 44 months |
Safety Issue: | |
Description: | EORTC QLQ LC13 is a lung cancer specific questionnaire module designed to supplement the EORTC QLQ C30. |
Measure: | Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and immune related adverse event (irAEs) |
Time Frame: | From consent signature (Day -28) until the 90 day post last dose follow-up |
Safety Issue: | |
Description: | |
Measure: | Number of participants with TEAEs leading to death |
Time Frame: | From consent signature (Day -28) until the 90 day post last dose follow-up |
Safety Issue: | |
Description: | |
Measure: | Number of participants with adverse events (AEs) leading to discontinuation |
Time Frame: | From consent signature (Day -28) until the 90 day post last dose follow-up |
Safety Issue: | |
Description: | |
Measure: | Number of participants with clinically significant changes in hematology, clinical chemistry, thyroid function and urinalysis lab parameters |
Time Frame: | From consent signature (Day -28) until the 90 day post last dose follow-up |
Safety Issue: | |
Description: | 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 abnormal findings in vital signs |
Time Frame: | From consent signature (Day -28) until the 90 day post last dose follow-up |
Safety Issue: | |
Description: | |
Measure: | Number of participants with indicated Eastern Cooperative Oncology Group (ECOG) performance status |
Time Frame: | From consent signature (Day -28) until the 90 day post last dose follow-up |
Safety Issue: | |
Description: | 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 abnormal findings in Electrocardiogram (ECG) Parameters |
Time Frame: | From consent signature (Day -28) until the 90 day post last dose follow-up |
Safety Issue: | |
Description: | 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 usage of concomitant medications |
Time Frame: | From consent signature (Day -28) until the 90 day post last dose follow-up |
Safety Issue: | |
Description: | |
Measure: | Number of participants with abnormal physical examinations |
Time Frame: | From consent signature (Day -28) until the 90 day post last dose follow-up |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2/Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | GlaxoSmithKline |
Trial Keywords
- GSK4069889A
- GSK4057190A
- Cobolimab
- Dostarlimab
- Docetaxel
- Chemotherapy
Last Updated
July 27, 2021