Phase 2 Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non Small Cell Lung Cancer

• Status: Not yet recruiting
• Trial end date: 2025-12-12
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PDy) of novel immunotherapy combinations compared with immunotherapy monotherapy in participants with Programmed death ligand-1 (PD L-1) high (Tumor cells [TC]/ Tumor proportion score [TPS] ≥ 50%), previously untreated, unresectable, locally advanced or metastatic NSCLC. Drug name mentioned as GSK4428859A and EOS884448 are interchangeable for the same compound. In the rest of the document, the drug will be referred to as GSK4428859A (EOS884448).

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

Details

• Lead Sponsor: GlaxoSmithKline
• Collaborator: iTeos Therapeutics
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of locally advanced unresectable NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy or metastatic NSCLC (squamous or non squamous)

• No prior systemic therapy for their locally advanced or metastatic NSCLC

• Provides a fresh tumor tissue sample or archival sample collected within 6 months of screening

• PD-L1-high (TC/TPS ≥ 50%) tumor

• Measurable disease based on RECIST 1.1, as determined by the investigator

• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

• Adequate baseline organ function

• Female participants of childbearing potential must use adequate contraception

Exclusion Criteria:

• Presence of Epidermal growth factor receptor (EGFR) mutations, Anaplastic lymphoma kinase (ALK) translocations, or other known genomic aberrations or oncogenic driver mutations for which a locally approved therapy is available. All participants with non squamous histology must have been tested for EGFR mutation and ALK translocation status.

• Had major surgery within 4 weeks or lung radiation therapy within 6 months of the first dose of study intervention

• Received prior therapy with any immune checkpoint inhibitors

• Never smoker, defined as smoking <100 tobacco cigarettes in a lifetime

• History of invasive malignancy other than the disease under study within the last 5 years

• Symptomatic, untreated, or actively progressing brain metastases and/or leptomeningeal disease

• Autoimmune disease or syndrome that required systemic treatment within the past 2 years

• Receiving any form of immunosuppressive medication

• Received any live vaccine ≤ 30 days prior to first dose of study intervention

• Any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis

• History or evidence of cardiac abnormalities ≤ 3 months prior to enrollment

• Current unstable liver or biliary disease

• Severe infection within 4 weeks prior to randomization

• Positive for tuberculosis, human immunodeficiency virus infection, hepatitis B, or hepatitis C