Last updated: 01/08/2026 12:10:13
A Platform Study of Novel Immunotherapy Combinations in Participants with Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer
GSK study ID
213824
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
Official title: A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants with Previously Untreated, Locally Advanced/Metastatic, Programmed Death Ligand 1-Selected Non-Small-Cell Lung Cancer
Trial description: This study will monitor the safety of novel immunotherapy combinations 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 non-small cell lung cancer (NSCLC). Drug name mentioned as Belrestotug, GSK4428859A, and EOS884448 are all interchangeable for the same compound. In the rest of the document, the drug will be referred to as Belrestotug.
Primary purpose:
Treatment
Trial design:
Parallel
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timeframe: Up to 228 weeks
Number of Participants with TEAEs or SAEs leading to dose modifications or treatment discontinuation
Timeframe: Up to 228 weeks
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
351
Primary completion date:
2027-26-02
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Lung Cancer, Non-Small Cell
Product
Not applicable
Collaborators
iTeos Therapeutics
Study date(s)
October 2022 to February 2027
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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
- Has NSCLC with a tumor that harbors any of the following molecular alterations: EGFR and /or ALK translocations mutations that are sensitive to available targeted inhibitor therapy, Any other known genomic aberrations or oncogenic driver mutations for which a locally approved targeted therapy is available for first-line treatment of locally advanced or metastatic NSCLC.
- Had major surgery within 4 weeks or lung radiation of >30 Gy therapy within 6 months prior to the first dose of study intervention
Inclusion and exclusion 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 2 years prior to 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:
- Has NSCLC with a tumor that harbors any of the following molecular alterations: EGFR and /or ALK translocations mutations that are sensitive to available targeted inhibitor therapy, Any other known genomic aberrations or oncogenic driver mutations for which a locally approved targeted therapy is available for first-line treatment of locally advanced or metastatic NSCLC.
- Had major surgery within 4 weeks or lung radiation of >30 Gy therapy within 6 months prior to the first dose of study intervention
- Received prior therapy with any immune checkpoint inhibitors
- Never smoked, defined as smoking <100 tobacco cigarettes in a lifetime
- Has an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years (clinical exceptions apply as per protocol)
- Symptomatic, untreated, or actively progressing, brain metastases or any leptomeningeal disease (regardless of symptomatology, treatment status, or stability)
- Autoimmune disease or syndrome that required systemic treatment within the past 2 years
- Receiving systemic steroid therapy <= 3 days prior to first dose of study intervention or 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
- Current unstable liver or biliary disease
- Severe infection within 4 weeks prior to the first dose of study intervention
- Positive for tuberculosis, human immunodeficiency virus (HIV) infection, hepatitis B surface antigen, or hepatitis C
- Has advanced, symptomatic, or visceral spread and is considered to be at imminent risk of life-threatening complications (including, but not limited to, massive uncontrolled effusions [e.g., pleural, pericardial, peritoneal])
- Is currently participating in or has participated in a study of an investigational therapy within 4 weeks prior to the first dose of study intervention
- Has a history of allogeneic tissue/stem cell transplant or solid organ transplant
Trial location(s)
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina, C1426AGE
Status
Unmapped
Location
GSK Investigational Site
Pozuelo de AlarcOn Madr, Spain, 28223
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Las Palmas De Gran Canar, Spain, 35016
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina, 1414
Status
Unmapped
Location
GSK Investigational Site
Boston, MA, Unmapped, 02118-2905
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina, C1430EGF
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Los Angeles, CA, Unmapped, 90017
Status
Terminated/Withdrawn
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruitment complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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