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)

February 18, 2024 updated by: GlaxoSmithKline

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

758

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
        • GSK Investigational Site
      • La Rioja, Argentina, F5300COE
        • GSK Investigational Site
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1425
        • GSK Investigational Site
      • Florida, Buenos Aires, Argentina, 1602
        • GSK Investigational Site
      • Pergamino, Buenos Aires, Argentina, B2700CPM
        • GSK Investigational Site
    • Río Negro
      • Cipoletti, Rio Negro, Río Negro, Argentina, R8324CVE
        • GSK Investigational Site
      • Viedma, Río Negro, Argentina, R8500ACE
        • GSK Investigational Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DBS
        • GSK Investigational Site
  • Australia
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • GSK Investigational Site
      • South Brisbane, South Australia, Australia, 4101
        • GSK Investigational Site
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • GSK Investigational Site
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • GSK Investigational Site
      • Melbourne, Victoria, Australia, 3004
        • GSK Investigational Site
  • Belgium
      • Aalst, Belgium, 9300
        • GSK Investigational Site
      • Hasselt, Belgium, 3500
        • GSK Investigational Site
      • Kortrijk, Belgium, 8500
        • GSK Investigational Site
  • Brazil
      • Rio de Janeiro, Brazil, 22250-905
        • GSK Investigational Site
      • Rio de Janeiro, Brazil, 22061080
        • GSK Investigational Site
      • São Paulo, Brazil, 04014-002
        • GSK Investigational Site
    • Bahia
      • Ondina, Bahia, Brazil, 40170-110
        • GSK Investigational Site
    • Ceará
      • Fortaleza, Ceará, Brazil, 60336-232
        • GSK Investigational Site
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610000
        • GSK Investigational Site
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89010340
        • GSK Investigational Site
  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • GSK Investigational Site
      • Oshawa, Ontario, Canada, L1G 2B9
        • GSK Investigational Site
      • Sudbury, Ontario, Canada, P3E 5J1
        • GSK Investigational Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H3T 1E2
        • GSK Investigational Site
  • Finland
      • Helsinki, Finland, 00180
        • GSK Investigational Site
      • Kuopio, Finland, 70210
        • GSK Investigational Site
      • Tampere, Finland, 33520
        • GSK Investigational Site
      • Turku, Finland, 20520
        • GSK Investigational Site
  • France
      • Créteil Cedex, France, 94010
        • GSK Investigational Site
      • Grenoble cedex 9, France, 38043
        • GSK Investigational Site
      • Marseille, France, 13009
        • GSK Investigational Site
      • Nice Cedex 2, France, 06189
        • GSK Investigational Site
      • Quimper cedex, France, 29107
        • GSK Investigational Site
      • Rennes Cedex 9, France, 35033
        • GSK Investigational Site
      • Tours cedex 9, France, 37044
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 12200
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Heidelberg, Baden-Wuerttemberg, Germany, 69126
        • GSK Investigational Site
      • Karlsruhe, Baden-Wuerttemberg, Germany, 76137
        • GSK Investigational Site
    • Bayern
      • Augsburg, Bayern, Germany, 86156
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80336
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81925
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Germany, 60488
        • GSK Investigational Site
      • Frankfurt am Main, Hessen, Germany, 60590
        • GSK Investigational Site
    • Niedersachsen
      • Oldenburg, Niedersachsen, Germany, 26121
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53113
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Germany, 45147
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Germany, 51109
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
        • GSK Investigational Site
    • Thueringen
      • Bad Berka, Thueringen, Germany, 99437
        • GSK Investigational Site
  • Greece
      • Athens, Greece, 115 27
        • GSK Investigational Site
      • Athens, Greece, 11528
        • GSK Investigational Site
      • Athens, Greece, 12462
        • GSK Investigational Site
      • Athens, Greece, 11526
        • GSK Investigational Site
      • Larissa, Greece, 41100
        • GSK Investigational Site
      • Patras, Greece, 26504
        • GSK Investigational Site
      • Thessaloniki, Greece, 57010
        • GSK Investigational Site
      • Thessaloniki, Greece, 570 01
        • GSK Investigational Site
      • Thessaloniki, Greece, 55236
        • GSK Investigational Site
  • Italy
    • Campania
      • Avellino, Campania, Italy, 83100
        • GSK Investigational Site
      • Napoli, Campania, Italy, 80131
        • GSK Investigational Site
    • Lombardia
      • Milano, Lombardia, Italy, 20132
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20133
        • GSK Investigational Site
      • Monza, Lombardia, Italy, 20900
        • GSK Investigational Site
    • Marche
      • Torrette (AN), Marche, Italy, 60126
        • GSK Investigational Site
    • Piemonte
      • Orbassano (TO), Piemonte, Italy, 10043
        • GSK Investigational Site
    • Toscana
      • Firenze, Toscana, Italy, 50134
        • GSK Investigational Site
      • Siena, Toscana, Italy, 53100
        • GSK Investigational Site
    • Umbria
      • Perugia, Umbria, Italy, 06156
        • GSK Investigational Site
  • Japan
      • Kyoto, Japan, 612-8555
        • GSK Investigational Site
      • Miyagi, Japan, 981-1293
        • GSK Investigational Site
      • Osaka, Japan, 591-8555
        • GSK Investigational Site
      • Yamaguchi, Japan, 755-0241
        • GSK Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • GSK Investigational Site
      • Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
        • GSK Investigational Site
      • Daegu-si, Korea, Republic of, 42601
        • GSK Investigational Site
      • Gyeonggi-do, Korea, Republic of, 10408
        • GSK Investigational Site
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 06351
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 08308
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 05505
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 03722
        • GSK Investigational Site
      • Suwon-Si, Korea, Republic of, 443-721
        • GSK Investigational Site
  • Mexico
      • Mexico City, Mexico, CP 14080
        • GSK Investigational Site
      • Puebla, Mexico, 72560
        • GSK Investigational Site
    • Ciudad De Mexico
      • Benito Juarez, Ciudad De Mexico, Mexico, 03810
        • GSK Investigational Site
      • Mexico, Ciudad De Mexico, Mexico, 03100
        • GSK Investigational Site
      • Mexico City, Ciudad De Mexico, Mexico, 06700
        • GSK Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • GSK Investigational Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • GSK Investigational Site
  • Netherlands
      • Amersfoort, Netherlands, 3813 TZ
        • GSK Investigational Site
      • Enschede, Netherlands, 7512 KZ
        • GSK Investigational Site
      • Groningen, Netherlands, 9713 GZ
        • GSK Investigational Site
      • Harderwijk, Netherlands, 3844 DG
        • GSK Investigational Site
      • Nijmegen, Netherlands, 6525 GA
        • GSK Investigational Site
      • Utrecht, Netherlands, 3543 AZ
        • GSK Investigational Site
      • Zwolle, Netherlands, 8025 AB
        • GSK Investigational Site
  • Poland
      • Bydgoszcz, Poland, 85-796
        • GSK Investigational Site
      • Gdynia, Poland, 81-519
        • GSK Investigational Site
      • Lodz, Poland, 90-338
        • GSK Investigational Site
      • Olsztyn, Poland, 10-357
        • GSK Investigational Site
      • Pila, Poland, 64-920
        • GSK Investigational Site
      • Poznan, Poland, 60-693
        • GSK Investigational Site
  • Romania
      • Bucuresti, Romania, 021389
        • GSK Investigational Site
      • Craiova, Romania, 200385
        • GSK Investigational Site
      • Craiova, Romania, 200347
        • GSK Investigational Site
      • Otopeni, Romania, 075100
        • GSK Investigational Site
      • Timisoara, Romania, 300239
        • GSK Investigational Site
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454048
        • GSK Investigational Site
      • Moscow, Russian Federation, 143423
        • GSK Investigational Site
      • Pushkin, Russian Federation, 196603
        • GSK Investigational Site
      • Saint-Petersburg, Russian Federation, 197022
        • GSK Investigational Site
  • Spain
      • Badalona, Spain, 08916
        • GSK Investigational Site
      • Barcelona, Spain, 08036
        • GSK Investigational Site
      • Barcelona, Spain, 08035
        • GSK Investigational Site
      • Burgos, Spain, 09006
        • GSK Investigational Site
      • Cordoba, Spain, 140044
        • GSK Investigational Site
      • La Coruña, Spain, 15006
        • GSK Investigational Site
      • Las Palmas De Gran Canaria, Spain, 35016
        • GSK Investigational Site
      • Madrid, Spain, 28041
        • GSK Investigational Site
      • Madrid, Spain, 28007
        • GSK Investigational Site
      • Madrid, Spain, 28046
        • GSK Investigational Site
      • Madrid, Spain, 28034
        • GSK Investigational Site
      • Madrid, Spain, 28050
        • GSK Investigational Site
      • Majadahonda (Madrid), Spain, 28222
        • GSK Investigational Site
      • Malaga, Spain, 29010
        • GSK Investigational Site
      • Valencia, Spain, 46026
        • GSK Investigational Site
  • Sweden
      • Gävle, Sweden, SE-801 87
        • GSK Investigational Site
      • Solna, Sweden, 171 64
        • GSK Investigational Site
      • Uppsala, Sweden, SE-751 85
        • GSK Investigational Site
  • Taiwan
      • Hsinchu City, Taiwan, 300
        • GSK Investigational Site
      • New Taipei City, Taiwan, 23561
        • GSK Investigational Site
      • Taichung, Taiwan, 407
        • GSK Investigational Site
      • Taipei City, Taiwan, 11217
        • GSK Investigational Site
  • Thailand
      • Bangkok, Thailand, 10210
        • GSK Investigational Site
      • Dusit, Thailand, 10300
        • GSK Investigational Site
      • Hat Yai, Thailand, 90110
        • GSK Investigational Site
      • Khlong Luang, Thailand, 12120
        • GSK Investigational Site
      • Muang, Thailand, 40002
        • GSK Investigational Site
  • Turkey
      • Adana, Turkey, 1120
        • GSK Investigational Site
      • Antalya, Turkey, 07020
        • GSK Investigational Site
      • Izmir, Turkey, 35600
        • GSK Investigational Site
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • GSK Investigational Site
      • London, United Kingdom, SE1 9RT
        • GSK Investigational Site
      • London, United Kingdom, W1G 6AD
        • GSK Investigational Site
      • Manchester, United Kingdom, M20 4BX
        • GSK Investigational Site
      • Whitchurch, Cardiff, United Kingdom, CF14 2TL
        • GSK Investigational Site
  • United States
    • California
      • Cerritos, California, United States, 90703
        • GSK Investigational Site
      • Fountain Valley, California, United States, 92708
        • GSK Investigational Site
      • Los Angeles, California, United States, 90034
        • GSK Investigational Site
      • Oakland, California, United States, 94611
        • GSK Investigational Site
      • Roseville, California, United States, 95661
        • GSK Investigational Site
      • San Francisco, California, United States, 94115
        • GSK Investigational Site
      • San Francisco, California, United States, 94121
        • GSK Investigational Site
      • Santa Clara, California, United States, 95051
        • GSK Investigational Site
      • Vallejo, California, United States, 94589
        • GSK Investigational Site
      • Walnut Creek, California, United States, 94596
        • GSK Investigational Site
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • GSK Investigational Site
    • Florida
      • Orange City, Florida, United States, 32763
        • GSK Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • GSK Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • GSK Investigational Site
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • GSK Investigational Site
      • Louisville, Kentucky, United States, 42061
        • GSK Investigational Site
    • Montana
      • Billings, Montana, United States, 59102
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • GSK Investigational Site
    • New York
      • Bronx, New York, United States, 10468
        • GSK Investigational Site
      • Mineola, New York, United States, 11501
        • GSK Investigational Site
      • New York, New York, United States, 10016
        • GSK Investigational Site
      • New York, New York, United States, 10010
        • GSK Investigational Site
      • Northport, New York, United States, 11768
        • GSK Investigational Site
      • White Plains, New York, United States, 10601
        • GSK Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15224
        • GSK Investigational Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • GSK Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • GSK Investigational Site
      • Memphis, Tennessee, United States, 38104
        • GSK Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • GSK Investigational Site
    • Virginia
      • Fredericksburg, Virginia, United States, 22408
        • GSK Investigational Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants receiving cobolimab+dostarlimab+docetaxel
Biological: Cobolimab
Cobolimab will be administered
Biological: Dostarlimab
Dostarlimab will be administered
Drug: Docetaxel
Docetaxel will be administered
Experimental: Participants receiving dostarlimab+docetaxel
Biological: Dostarlimab
Dostarlimab will be administered
Drug: Docetaxel
Docetaxel will be administered
Active Comparator: Participants receiving docetaxel
Drug: Docetaxel
Docetaxel will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 44 months
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
Up to 44 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 44 months
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
Up to 44 months
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
Up to 44 months
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
Up to 44 months
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)
Up to 44 months
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.
Baseline (Day 1) and up to 44 months
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.
Baseline (Day 1) and up to 44 months
Number of participants with serious adverse events (SAEs)
Time Frame: From consent signature (Day -28) until the 90 day post last dose follow-up
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
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
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
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
From consent signature (Day -28) until the 90 day post last dose follow-up
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
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.
From consent signature (Day -28) until the 90 day post last dose follow-up
Number of participants with usage of concomitant medications
Time Frame: From consent signature (Day -28) until the 90 day post last dose follow-up
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
From consent signature (Day -28) until the 90 day post last dose follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2020

Primary Completion (Estimated)

October 7, 2024

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

November 30, 2020

First Submitted That Met QC Criteria

November 30, 2020

First Posted (Actual)

December 7, 2020

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 213410
  • 2020-003433-37 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer, Non-Small Cell

Clinical Trials on Cobolimab

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
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