Clinical Trials /

Study of Cobolimab in Combination With Dostarlimab and Docetaxel in Advanced NSCLC Participants

NCT04655976

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
CobolimabParticipants receiving cobolimab+dostarlimab+docetaxel
DostarlimabParticipants receiving cobolimab+dostarlimab+docetaxel
DocetaxelParticipants 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

NameTypeDescriptionInterventions
Participants receiving cobolimab+dostarlimab+docetaxelExperimental
  • Cobolimab
  • Dostarlimab
  • Docetaxel
Participants receiving dostarlimab+docetaxelExperimental
  • Dostarlimab
  • Docetaxel
Participants receiving docetaxelActive Comparator
  • Docetaxel

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
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:GlaxoSmithKline

Trial Keywords

  • GSK4069889A
  • GSK4057190A
  • Cobolimab
  • Dostarlimab
  • Docetaxel
  • Chemotherapy

Last Updated

April 6, 2021