Informations générales (source: ClinicalTrials.gov)
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) (COSTAR Lung)
Interventional
Phase 2/Phase 3
GlaxoSmithKline (Voir sur ClinicalTrials)
décembre 2020
octobre 2025
19 octobre 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Christos CHOUAID | 29/03/2024 01:29:41 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| GSK Investigational Site - 06189 - Nice Cedex 2 - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 13009 - Marseille - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 29107 - Quimper cedex - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 35033 - Rennes Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 37044 - Tours cedex 9 - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 38043 - Grenoble cedex 9 - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 94010 - Créteil Cedex - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.
- 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).