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Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-Small Cell Lung Cancer Who Have Progressed on Prior Anti- Programmed Death-ligand 1 (PD-[L]1) Therapy and Chemotherapy (COSTAR Lung)

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ClinicalTrials.gov Identifier: NCT04655976
Recruitment Status : Active, not recruiting
First Posted : December 7, 2020
Last Update Posted : February 20, 2024
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE November 30, 2020
First Posted Date  ICMJE December 7, 2020
Last Update Posted Date February 20, 2024
Actual Study Start Date  ICMJE December 8, 2020
Estimated Primary Completion Date October 7, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2020)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2022)
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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.
  • 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.
  • Number of participants with serious adverse events (SAEs) [ Time Frame: From consent signature (Day -28) until the 90 day post last dose follow-up ]
  • Number of participants with treatment-emergent adverse events (TEAEs) and immune related adverse event (irAEs) [ Time Frame: From consent signature (Day -28) until the 30 day post last dose follow-up ]
  • Number of participants with TEAEs leading to death [ Time Frame: From consent signature (Day -28) until the 90 day post last dose follow-up ]
  • Number of participants with adverse events (AEs) leading to discontinuation [ Time Frame: From consent signature (Day -28) until the 30 day post last dose follow-up ]
  • 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
  • Number of participants with clinically significant changes in vital signs and Electrocardiogram (ECG) Parameters [ Time Frame: From consent signature (Day -28) until the 90 day post last dose follow-up ]
  • 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.
  • Number of participants with usage of concomitant medications [ Time Frame: From consent signature (Day -28) until the 90 day post last dose follow-up ]
  • Number of participants with abnormal physical examinations [ Time Frame: From consent signature (Day -28) until the 90 day post last dose follow-up ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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.
  • 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.
  • 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 ]
  • Number of participants with TEAEs leading to death [ Time Frame: From consent signature (Day -28) until the 90 day post last dose follow-up ]
  • 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 ]
  • 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
  • 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 ]
  • 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.
  • 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.
  • Number of participants with usage of concomitant medications [ Time Frame: From consent signature (Day -28) until the 90 day post last dose follow-up ]
  • Number of participants with abnormal physical examinations [ Time Frame: From consent signature (Day -28) until the 90 day post last dose follow-up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-Small Cell Lung Cancer Who Have Progressed on Prior Anti- Programmed Death-ligand 1 (PD-[L]1) Therapy and Chemotherapy
Official Title  ICMJE 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)
Brief Summary This is a multi-center, parallel group treatment, Phase 2/3 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced Non-small cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE Lung Cancer, Non-Small Cell
Intervention  ICMJE
  • Biological: Cobolimab
    Cobolimab will be administered
  • Biological: Dostarlimab
    Dostarlimab will be administered
  • Drug: Docetaxel
    Docetaxel will be administered
Study Arms  ICMJE
  • Experimental: Participants receiving cobolimab+dostarlimab+docetaxel
    Interventions:
    • Biological: Cobolimab
    • Biological: Dostarlimab
    • Drug: Docetaxel
  • Experimental: Participants receiving dostarlimab+docetaxel
    Interventions:
    • Biological: Dostarlimab
    • Drug: Docetaxel
  • Active Comparator: Participants receiving docetaxel
    Intervention: Drug: Docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 3, 2023)
758
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2020)
250
Estimated Study Completion Date  ICMJE October 31, 2025
Estimated Primary Completion Date October 7, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant has histologically or cytologically proven advanced or metastatic NSCLC and only squamous or non-squamous cell carcinoma.
  • Participant has received no more than 2 prior lines of therapy for advanced or metastatic disease, which must only include a platinum based (e.g., cisplatin, carboplatin) doublet chemotherapy regimen and an anti-PD-1 or 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 formalin-fixed paraffin-embedded (FFPE) 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-PD-[L]1 or anti-programmed death-ligand 2 (anti-PD-[L]2) agent that resulted in permanent discontinuation due to an 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 a documented sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (ROS-1) mutation. Participants whose tumors have not been tested for these driver mutations and therefore who have unknown driver mutation status are not eligible. Participants with squamous histology do not need to be tested for these driver mutations.
  • 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-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) >2.5 times upper limit normal (ULN) b. ALT and/or aspartate aminotransferase (AST) >1.5 times ULN concomitant with alkaline phosphatase (ALP) >2.5 times ULN; c. Bilirubin >1 times ULN; d. 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 tested positive for the following at Screening or within 3 months before the first dose of study treatment: a. Presence of hepatitis B surface antigen. b. Presence of hepatitis C antibody in the absence of a ribonucleic acid (RNA) test for hepatitis C virus. If a confirmatory RNA test is available, a positive test result will exclude a participant, while a negative test result (indicating absence of active infection) will allow the participant to enter into the study.
  • 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 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.
  • Participant has received a live vaccine within 30 days of the first dose of study treatment. Seasonal flu vaccines that do not contain live virus and Coronavirus Disease 2019 (COVID-19) vaccines.
  • Participant is unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) for undergoing a biopsy procedure (in cases when a participant does not have an archival biopsy), other than an aspirin dose <=1.3 grams (g) per day, for a 5-day period (8-day) period for long-acting agents, such as piroxicam).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   Finland,   France,   Germany,   Greece,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Romania,   Russian Federation,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04655976
Other Study ID Numbers  ICMJE 213410
2020-003433-37 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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
Current Responsible Party GlaxoSmithKline
Original Responsible Party Same as current
Current Study Sponsor  ICMJE GlaxoSmithKline
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP