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History of Changes for Study: NCT04655976
Study of Cobolimab in Combination With Dostarlimab and Docetaxel in Advanced NSCLC Participants (COSTAR Lung)
Latest version (submitted February 18, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 30, 2020 None (earliest Version on record)
2 December 8, 2020 Study Status and Contacts/Locations
3 January 11, 2021 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 January 22, 2021 Contacts/Locations and Study Status
5 January 29, 2021 Contacts/Locations and Study Status
6 February 26, 2021 Study Status and Contacts/Locations
7 April 5, 2021 Study Status and Contacts/Locations
8 May 5, 2021 Study Status and Contacts/Locations
9 May 18, 2021 Contacts/Locations, Study Design and Study Status
10 June 24, 2021 Study Status and Contacts/Locations
11 July 23, 2021 Study Status and Contacts/Locations
12 November 16, 2021 Study Status and Contacts/Locations
13 February 28, 2022 Contacts/Locations and Study Status
14 April 12, 2022 Outcome Measures, Study Status, Eligibility, Arms and Interventions, Study Description and Study Identification
15 November 15, 2022 Study Status, Study Design and Study Description
16 November 3, 2023 Recruitment Status, Contacts/Locations, Study Status and Study Design
17 December 11, 2023 Contacts/Locations and Study Status
18 February 18, 2024 Contacts/Locations and Study Status
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Study NCT04655976
Submitted Date:  November 30, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 213410
Brief Title: Study of Cobolimab in Combination With Dostarlimab and Docetaxel in Advanced NSCLC Participants (COSTAR Lung)
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)
Secondary IDs: 2020-003433-37 [EudraCT Number]
Open or close this module Study Status
Record Verification: November 2020
Overall Status: Not yet recruiting
Study Start: January 15, 2021
Primary Completion: September 6, 2024 [Anticipated]
Study Completion: January 1, 2026 [Anticipated]
First Submitted: November 30, 2020
First Submitted that
Met QC Criteria:
November 30, 2020
First Posted: December 7, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
November 30, 2020
Last Update Posted: December 7, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: GlaxoSmithKline
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:
Open or close this module Conditions
Conditions: Lung Cancer, Non-Small Cell
Keywords: GSK4069889A
GSK4057190A
Cobolimab
Dostarlimab
Docetaxel
Chemotherapy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Participants will receive treatment in a 2:2:1 randomisation; cobolimab + dostarlimab + docetaxel; dostarlimab + docetaxel; docetaxel.
Number of Arms: 3
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 250 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Participants receiving cobolimab+dostarlimab+docetaxel Biological: Cobolimab
Route of administration : IV infusion
Biological: Dostarlimab
Route of administration : IV infusion
Drug: Docetaxel
Route of administration : IV infusion
Experimental: Participants receiving dostarlimab+docetaxel Biological: Dostarlimab
Route of administration : IV infusion
Drug: Docetaxel
Route of administration : IV infusion
Active Comparator: Participants receiving docetaxel Drug: Docetaxel
Route of administration : IV infusion
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall survival (OS) in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving docetaxel alone
[ Time Frame: Up to 44 months ]

OS is defined as survival from the date of randomization to the date of death by any cause
2. OS in participants receiving dostarlimab + docetaxel relative to participants receiving docetaxel alone
[ Time Frame: Up to 44 months ]

OS is defined as survival from the date of randomization to the date of death by any cause
Secondary Outcome Measures:
1. OS in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving dostarlimab + docetaxel
[ Time Frame: Up to 44 months ]

OS is defined as survival from the date of randomization to the date of death by any cause
2. Objective response rate (ORR)
[ Time Frame: Up to 44 months ]

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
3. Progression free survival (PFS)
[ Time Frame: Up to 44 months ]

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
4. Duration of response (DOR)
[ Time Frame: Up to 44 months ]

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
5. Time to deterioration (TTD)
[ Time Frame: Up to 44 months ]

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)
6. 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 ]

EORTC QLQ-C30 is a questionnaire used to measure health related quality of life (HRQoL) in participants with cancer.
7. Change from Baseline in the EORTC QLQ LC13 assessment
[ Time Frame: Baseline (Day 1) and up to 44 months ]

EORTC QLQ LC13 is a lung cancer specific questionnaire module designed to supplement the EORTC QLQ C30.
8. 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 ]

9. Number of participants with TEAEs leading to death
[ Time Frame: From consent signature (Day -28) until the 90 day post last dose follow-up ]

10. 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 ]

11. 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 ]

Blood and urine samples will be collected for the assessment of hematology, clinical chemistry, thyroid function and urinalysis lab parameters
12. 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 ]

13. 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 ]

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.
14. 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 ]

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.
15. Number of participants with usage of concomitant medications
[ Time Frame: From consent signature (Day -28) until the 90 day post last dose follow-up ]

16. Number of participants with abnormal physical examinations
[ Time Frame: From consent signature (Day -28) until the 90 day post last dose follow-up ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: US GSK Clinical Trials Call Center
Telephone: 877-379-3718
Email: GSKClinicalSupportHD@gsk.com
Central Contact Backup: EU GSK Clinical Trials Call Center
Telephone: +44 (0) 20 89904466
Email: GSKClinicalSupportHD@gsk.com
Study Officials: GSK Clinical Trials
Study Director
GlaxoSmithKline
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes
IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame:
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access Criteria:
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com
Open or close this module References
Citations:
Links:
Available IPD/Information:

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