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

• Status: Recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Docetaxel

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.