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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04655976




Registration number
NCT04655976
Ethics application status
Date submitted
30/11/2020
Date registered
7/12/2020

Titles & IDs
Public title
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
Scientific 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 ID [1] 0 0
2020-003433-37
Secondary ID [2] 0 0
213410
Universal Trial Number (UTN)
Trial acronym
COSTAR Lung
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer, Non-Small Cell 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Cobolimab
Treatment: Other - Dostarlimab
Treatment: Drugs - Docetaxel

Experimental: Participants receiving cobolimab+dostarlimab+docetaxel -

Experimental: Participants receiving dostarlimab+docetaxel -

Active comparator: Participants receiving docetaxel -


Treatment: Other: Cobolimab
Cobolimab will be administered

Treatment: Other: Dostarlimab
Dostarlimab will be administered

Treatment: Drugs: Docetaxel
Docetaxel will be administered
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival (OS) in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving docetaxel alone
Timepoint [1] 0 0
Up to 44 months
Primary outcome [2] 0 0
OS in participants receiving dostarlimab + docetaxel relative to participants receiving docetaxel alone
Timepoint [2] 0 0
Up to 44 months
Secondary outcome [1] 0 0
OS in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving dostarlimab + docetaxel
Timepoint [1] 0 0
Up to 44 months
Secondary outcome [2] 0 0
Objective response rate (ORR)
Timepoint [2] 0 0
Up to 44 months
Secondary outcome [3] 0 0
Progression free survival (PFS)
Timepoint [3] 0 0
Up to 44 months
Secondary outcome [4] 0 0
Duration of response (DOR)
Timepoint [4] 0 0
Up to 44 months
Secondary outcome [5] 0 0
Time to deterioration (TTD)
Timepoint [5] 0 0
Up to 44 months
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Baseline (Day 1) and up to 44 months
Secondary outcome [7] 0 0
Change from Baseline in the EORTC QLQ LC13 assessment
Timepoint [7] 0 0
Baseline (Day 1) and up to 44 months
Secondary outcome [8] 0 0
Number of participants with serious adverse events (SAEs)
Timepoint [8] 0 0
From consent signature (Day -28) until the 90 day post last dose follow-up
Secondary outcome [9] 0 0
Number of participants with treatment-emergent adverse events (TEAEs) and immune related adverse event (irAEs)
Timepoint [9] 0 0
From consent signature (Day -28) until the 30 day post last dose follow-up
Secondary outcome [10] 0 0
Number of participants with TEAEs leading to death
Timepoint [10] 0 0
From consent signature (Day -28) until the 90 day post last dose follow-up
Secondary outcome [11] 0 0
Number of participants with adverse events (AEs) leading to discontinuation
Timepoint [11] 0 0
From consent signature (Day -28) until the 30 day post last dose follow-up
Secondary outcome [12] 0 0
Number of participants with clinically significant changes in hematology, clinical chemistry, thyroid function and urinalysis lab parameters
Timepoint [12] 0 0
From consent signature (Day -28) until the 90 day post last dose follow-up
Secondary outcome [13] 0 0
Number of participants with clinically significant changes in vital signs and Electrocardiogram (ECG) Parameters
Timepoint [13] 0 0
From consent signature (Day -28) until the 90 day post last dose follow-up
Secondary outcome [14] 0 0
Number of participants with indicated Eastern Cooperative Oncology Group (ECOG) performance status
Timepoint [14] 0 0
From consent signature (Day -28) until the 90 day post last dose follow-up
Secondary outcome [15] 0 0
Number of participants with usage of concomitant medications
Timepoint [15] 0 0
From consent signature (Day -28) until the 90 day post last dose follow-up
Secondary outcome [16] 0 0
Number of participants with abnormal physical examinations
Timepoint [16] 0 0
From consent signature (Day -28) until the 90 day post last dose follow-up

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
Accrual to date
Final
758
Recruitment in Australia
Recruitment state(s)
SA,TAS,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Kurralta Park
Recruitment hospital [2] 0 0
GSK Investigational Site - South Brisbane
Recruitment hospital [3] 0 0
GSK Investigational Site - Hobart
Recruitment hospital [4] 0 0
GSK Investigational Site - Ballarat
Recruitment hospital [5] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment postcode(s) [4] 0 0
3350 - Ballarat
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Hawaii
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Montana
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Dakota
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Argentina
State/province [17] 0 0
Buenos Aires
Country [18] 0 0
Argentina
State/province [18] 0 0
Río Negro
Country [19] 0 0
Argentina
State/province [19] 0 0
Santa Fe
Country [20] 0 0
Argentina
State/province [20] 0 0
Ciudad Autónoma de Buenos Aires
Country [21] 0 0
Argentina
State/province [21] 0 0
La Rioja
Country [22] 0 0
Belgium
State/province [22] 0 0
Aalst
Country [23] 0 0
Belgium
State/province [23] 0 0
Hasselt
Country [24] 0 0
Belgium
State/province [24] 0 0
Kortrijk
Country [25] 0 0
Brazil
State/province [25] 0 0
Bahia
Country [26] 0 0
Brazil
State/province [26] 0 0
Ceará
Country [27] 0 0
Brazil
State/province [27] 0 0
Rio Grande Do Sul
Country [28] 0 0
Brazil
State/province [28] 0 0
Santa Catarina
Country [29] 0 0
Brazil
State/province [29] 0 0
Rio de Janeiro
Country [30] 0 0
Brazil
State/province [30] 0 0
São Paulo
Country [31] 0 0
Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
Canada
State/province [32] 0 0
Quebec
Country [33] 0 0
Finland
State/province [33] 0 0
Helsinki
Country [34] 0 0
Finland
State/province [34] 0 0
Kuopio
Country [35] 0 0
Finland
State/province [35] 0 0
Tampere
Country [36] 0 0
Finland
State/province [36] 0 0
Turku
Country [37] 0 0
France
State/province [37] 0 0
Créteil Cedex
Country [38] 0 0
France
State/province [38] 0 0
Grenoble cedex 9
Country [39] 0 0
France
State/province [39] 0 0
Marseille
Country [40] 0 0
France
State/province [40] 0 0
Nice Cedex 2
Country [41] 0 0
France
State/province [41] 0 0
Quimper cedex
Country [42] 0 0
France
State/province [42] 0 0
Rennes Cedex 9
Country [43] 0 0
France
State/province [43] 0 0
Tours cedex 9
Country [44] 0 0
Germany
State/province [44] 0 0
Baden-Wuerttemberg
Country [45] 0 0
Germany
State/province [45] 0 0
Bayern
Country [46] 0 0
Germany
State/province [46] 0 0
Hessen
Country [47] 0 0
Germany
State/province [47] 0 0
Niedersachsen
Country [48] 0 0
Germany
State/province [48] 0 0
Nordrhein-Westfalen
Country [49] 0 0
Germany
State/province [49] 0 0
Sachsen-Anhalt
Country [50] 0 0
Germany
State/province [50] 0 0
Sachsen
Country [51] 0 0
Germany
State/province [51] 0 0
Thueringen
Country [52] 0 0
Germany
State/province [52] 0 0
Berlin
Country [53] 0 0
Greece
State/province [53] 0 0
Athens
Country [54] 0 0
Greece
State/province [54] 0 0
Larissa
Country [55] 0 0
Greece
State/province [55] 0 0
Patras
Country [56] 0 0
Greece
State/province [56] 0 0
Thessaloniki
Country [57] 0 0
Italy
State/province [57] 0 0
Campania
Country [58] 0 0
Italy
State/province [58] 0 0
Lombardia
Country [59] 0 0
Italy
State/province [59] 0 0
Marche
Country [60] 0 0
Italy
State/province [60] 0 0
Piemonte
Country [61] 0 0
Italy
State/province [61] 0 0
Toscana
Country [62] 0 0
Italy
State/province [62] 0 0
Umbria
Country [63] 0 0
Japan
State/province [63] 0 0
Kyoto
Country [64] 0 0
Japan
State/province [64] 0 0
Miyagi
Country [65] 0 0
Japan
State/province [65] 0 0
Osaka
Country [66] 0 0
Japan
State/province [66] 0 0
Yamaguchi
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Busan
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Cheongju-si, Chungcheongbuk-do
Country [69] 0 0
Korea, Republic of
State/province [69] 0 0
Daegu-si
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Gyeonggi-do
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Seongnam-si, Gyeonggi-do
Country [72] 0 0
Korea, Republic of
State/province [72] 0 0
Seoul
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Suwon-Si
Country [74] 0 0
Mexico
State/province [74] 0 0
Ciudad De Mexico
Country [75] 0 0
Mexico
State/province [75] 0 0
Jalisco
Country [76] 0 0
Mexico
State/province [76] 0 0
Nuevo León
Country [77] 0 0
Mexico
State/province [77] 0 0
Mexico City
Country [78] 0 0
Mexico
State/province [78] 0 0
Puebla
Country [79] 0 0
Netherlands
State/province [79] 0 0
Amersfoort
Country [80] 0 0
Netherlands
State/province [80] 0 0
Enschede
Country [81] 0 0
Netherlands
State/province [81] 0 0
Groningen
Country [82] 0 0
Netherlands
State/province [82] 0 0
Harderwijk
Country [83] 0 0
Netherlands
State/province [83] 0 0
Nijmegen
Country [84] 0 0
Netherlands
State/province [84] 0 0
Utrecht
Country [85] 0 0
Netherlands
State/province [85] 0 0
Zwolle
Country [86] 0 0
Poland
State/province [86] 0 0
Bydgoszcz
Country [87] 0 0
Poland
State/province [87] 0 0
Gdynia
Country [88] 0 0
Poland
State/province [88] 0 0
Lodz
Country [89] 0 0
Poland
State/province [89] 0 0
Olsztyn
Country [90] 0 0
Poland
State/province [90] 0 0
Pila
Country [91] 0 0
Poland
State/province [91] 0 0
Poznan
Country [92] 0 0
Romania
State/province [92] 0 0
Bucuresti
Country [93] 0 0
Romania
State/province [93] 0 0
Craiova
Country [94] 0 0
Romania
State/province [94] 0 0
Otopeni
Country [95] 0 0
Romania
State/province [95] 0 0
Timisoara
Country [96] 0 0
Russian Federation
State/province [96] 0 0
Chelyabinsk
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Moscow
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Pushkin
Country [99] 0 0
Russian Federation
State/province [99] 0 0
Saint-Petersburg
Country [100] 0 0
Spain
State/province [100] 0 0
Badalona
Country [101] 0 0
Spain
State/province [101] 0 0
Barcelona
Country [102] 0 0
Spain
State/province [102] 0 0
Burgos
Country [103] 0 0
Spain
State/province [103] 0 0
Cordoba
Country [104] 0 0
Spain
State/province [104] 0 0
La Coruña
Country [105] 0 0
Spain
State/province [105] 0 0
Las Palmas De Gran Canaria
Country [106] 0 0
Spain
State/province [106] 0 0
Madrid
Country [107] 0 0
Spain
State/province [107] 0 0
Majadahonda (Madrid)
Country [108] 0 0
Spain
State/province [108] 0 0
Malaga
Country [109] 0 0
Spain
State/province [109] 0 0
Valencia
Country [110] 0 0
Sweden
State/province [110] 0 0
Gävle
Country [111] 0 0
Sweden
State/province [111] 0 0
Solna
Country [112] 0 0
Sweden
State/province [112] 0 0
Uppsala
Country [113] 0 0
Taiwan
State/province [113] 0 0
Hsinchu City
Country [114] 0 0
Taiwan
State/province [114] 0 0
New Taipei City
Country [115] 0 0
Taiwan
State/province [115] 0 0
Taichung
Country [116] 0 0
Taiwan
State/province [116] 0 0
Taipei City
Country [117] 0 0
Thailand
State/province [117] 0 0
Bangkok
Country [118] 0 0
Thailand
State/province [118] 0 0
Dusit
Country [119] 0 0
Thailand
State/province [119] 0 0
Hat Yai
Country [120] 0 0
Thailand
State/province [120] 0 0
Khlong Luang
Country [121] 0 0
Thailand
State/province [121] 0 0
Muang
Country [122] 0 0
Turkey
State/province [122] 0 0
Adana
Country [123] 0 0
Turkey
State/province [123] 0 0
Antalya
Country [124] 0 0
Turkey
State/province [124] 0 0
Izmir
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Edinburgh
Country [126] 0 0
United Kingdom
State/province [126] 0 0
London
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Manchester
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Whitchurch, Cardiff

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04655976