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Study of Cobolimab in Combination With Dostarlimab and Docetaxel in Advanced NSCLC Participants (COSTAR Lung)

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ClinicalTrials.gov Identifier: NCT04655976
Recruitment Status : Recruiting
First Posted : December 7, 2020
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Lung Cancer, Non-Small Cell Biological: Cobolimab Biological: Dostarlimab Drug: Docetaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will receive treatment in a 2:2:1 randomisation; cobolimab + dostarlimab + docetaxel; dostarlimab + docetaxel; docetaxel.
Masking: None (Open Label)
Masking Description: This is an open label (unblinded) study.
Primary Purpose: Treatment
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)
Actual Study Start Date : December 8, 2020
Estimated Primary Completion Date : September 6, 2024
Estimated Study Completion Date : January 1, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
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




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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04655976


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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United States, Connecticut
GSK Investigational Site Recruiting
Norwich, Connecticut, United States, 06360
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Dinesh Kapur         
Australia, South Australia
GSK Investigational Site Recruiting
Kurralta Park, South Australia, Australia, 5037
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Nimit Singhal         
Australia, Victoria
GSK Investigational Site Recruiting
Ballarat, Victoria, Australia, 3350
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Wasek Faisal         
Italy
GSK Investigational Site Recruiting
Avellino, Campania, Italy, 83100
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Cesare Gridelli         
GSK Investigational Site Recruiting
Orbassano (TO), Piemonte, Italy, 10043
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Silvia Novello         
Korea, Republic of
GSK Investigational Site Recruiting
Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ki-Hyeong Lee         
GSK Investigational Site Recruiting
Gyeonggi-do, Korea, Republic of, 10408
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ji Youn Han         
GSK Investigational Site Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Yu Jung kim         
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 03722
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Hye Ryun Kim         
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 05505
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Dae-Ho Lee         
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 06351
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Se-Hoon Lee         
Poland
GSK Investigational Site Recruiting
Olsztyn, Poland, 10-357
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jaroslaw Kolb-Sielecki         
GSK Investigational Site Recruiting
Ostroleka, Poland, 07-410
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Agnieszka Domurad         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04655976    
Other Study ID Numbers: 213410
2020-003433-37 ( EudraCT Number )
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
GSK4069889A
GSK4057190A
Cobolimab
Dostarlimab
Docetaxel
Chemotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action