Novel Drug Regimens for Lung Cancer
Recruiting in Palo Alto (17 mi)
+64 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: GlaxoSmithKline
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
This trial is testing new treatment plans that include a drug called belrestotug. It targets patients with advanced lung cancer that has come back or hasn't responded to other treatments. The goal is to see if these new plans work better than the usual treatments.
Research Team
GC
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Eligibility Criteria
Adults with advanced non-small cell lung cancer (NSCLC) who've had disease progression after standard treatments, including a platinum-based chemotherapy and PD(L)1 inhibitor therapy. They must have measurable disease, be in good physical condition (ECOG score of 0 or 1), and have proper organ function. Women participating should not be pregnant or breastfeeding and must follow contraceptive guidance if of childbearing potential.Inclusion Criteria
I am a man and will use effective birth control during and for 4 months after treatment.
I had a positive response to previous PD(L)1 therapy but my cancer later progressed.
I can provide a tissue sample from my lung cancer, either new or from past tests.
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Exclusion Criteria
Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator
I have not had major surgery within the last 28 days.
Toxicity from previous anticancer treatment that includes: Greater than or equal to (>=) Grade 3 toxicity considered related to prior immunotherapy and that led to treatment discontinuation. History of myocarditis of any grade during a previous treatment with immunotherapy. Toxicity related to prior treatment that has not resolved to <= Grade 1 (except alopecia, hearing loss, endocrinopathy managed with replacement therapy, and peripheral neuropathy which must be <= Grade 2). History (current and past) of idiopathic pulmonary fibrosis, pneumonitis (for past- pneumonitis exclusion only if steroids were required for treatment), interstitial lung disease, or organizing pneumonia. Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions. Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess
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Treatment Details
Interventions
- Cobolimab (Monoclonal Antibodies)
- Docetaxel (Taxane)
- Dostarlimab (Monoclonal Antibodies)
- Feladilimab (Monoclonal Antibodies)
- GSK4428859A/EOS884448 (Monoclonal Antibodies)
- GSK6097608 (Monoclonal Antibodies)
- Ipilimumab (Checkpoint Inhibitor)
- Niraparib (PARP Inhibitor)
Trial OverviewThe trial is testing new treatments against the standard care for NSCLC that has relapsed or is refractory. It includes novel regimens either combined or as single agents. Part 1 assesses safety and pharmacokinetics, while Part 2 compares efficacy in a randomized phase II study.
Participant Groups
5Treatment groups
Experimental Treatment
Active Control
Group I: Part 2: Participants receiving feladilimab and docetaxelExperimental Treatment2 Interventions
Group II: Part 1: Participants receiving feladilimab and ipilimumabExperimental Treatment2 Interventions
Group III: Part 1: Participants receiving dostarlimab plus GSK4428859A/EOS884448/belrestotug plus GSK6097608Experimental Treatment3 Interventions
Group IV: Part 1: Participants receiving dostarlimab plus GSK4428859A/EOS884448/belrestotugExperimental Treatment2 Interventions
Group V: Part 2: Participants receiving SoC: docetaxelActive Control1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
iTeos Belgium SA
Industry Sponsor
Trials
9
Recruited
950+
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