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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04655976




Registration number
NCT04655976
Ethics application status
Date submitted
30/11/2020
Date registered
7/12/2020
Date last updated
20/02/2024

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
Other interventions - Cobolimab
Other interventions - Dostarlimab
Treatment: Drugs - Docetaxel

Experimental: Participants receiving cobolimab+dostarlimab+docetaxel -

Experimental: Participants receiving dostarlimab+docetaxel -

Active Comparator: Participants receiving docetaxel -


Other interventions: Cobolimab
Cobolimab will be administered

Other interventions: Dostarlimab
Dostarlimab will be administered

Treatment: Drugs: Docetaxel
Docetaxel will be administered
Intervention code [1] 0 0
Other interventions
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/Phase 3
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
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Connecticut
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District of Columbia
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Florida
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Hawaii
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Iowa
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Kentucky
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Montana
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United States of America
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Nevada
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New York
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Pennsylvania
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South Dakota
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Tennessee
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Texas
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Virginia
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Washington
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Argentina
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Buenos Aires
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Argentina
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Río Negro
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Argentina
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Santa Fe
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Argentina
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Ciudad Autónoma de Buenos Aires
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Argentina
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La Rioja
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Belgium
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Aalst
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Belgium
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Hasselt
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Kortrijk
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Bahia
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Ceará
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Grenoble cedex 9
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Rennes Cedex 9
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Tours cedex 9
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Bayern
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Hessen
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Piemonte
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Toscana
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Umbria
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Kyoto
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Miyagi
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Osaka
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Japan
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Yamaguchi
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Korea, Republic of
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Busan
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Korea, Republic of
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Cheongju-si, Chungcheongbuk-do
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Korea, Republic of
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Daegu-si
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seongnam-si, Gyeonggi-do
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon-Si
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Mexico
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Ciudad De Mexico
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Mexico
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Jalisco
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Nuevo León
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Mexico
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Mexico City
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Mexico
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Puebla
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Netherlands
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Amersfoort
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Enschede
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Groningen
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Harderwijk
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Nijmegen
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Utrecht
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Netherlands
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Zwolle
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Poland
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Bydgoszcz
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Poland
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Gdynia
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Lodz
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Olsztyn
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Poland
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Pila
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Poland
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Poznan
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Romania
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Bucuresti
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Romania
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Craiova
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Romania
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Otopeni
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Romania
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Timisoara
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Russian Federation
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Chelyabinsk
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Russian Federation
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Moscow
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Russian Federation
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Pushkin
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Russian Federation
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Saint-Petersburg
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Spain
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Badalona
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Spain
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Barcelona
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Burgos
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Cordoba
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Spain
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La Coruña
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Spain
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Las Palmas De Gran Canaria
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Spain
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Madrid
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Spain
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Majadahonda (Madrid)
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Spain
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Malaga
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Spain
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Valencia
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Sweden
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Gävle
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Sweden
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Solna
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Sweden
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Uppsala
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Taiwan
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Hsinchu City
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Taiwan
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New Taipei City
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Taiwan
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Taichung
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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
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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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04655976
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04655976