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

NCT05565378
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Phase
Phase 2
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Recruitment status
Active, not recruiting
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Participants
351
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Lead sponsor
GlaxoSmithKline
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Start date
2022-10-14
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Number of sites
99
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Summary
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.
clinicaltrials.gov
Short title
A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer
clinicaltrials.gov
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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2027-12-06
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First posted
2022-10-04
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Registry last updated
2026-06-15
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Primary completion date
2026-11-09
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Start date
2022-10-14
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Actual participants
351
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Participants
351
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Participant count basis
Actual
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Protocol amendments
5
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Number of sites
99
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
GlaxoSmithKline
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05565378
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ClinicalTrials.gov ID
NCT05565378
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Timeframe: Up to 228 weeks

  2. Number of Participants with TEAEs or SAEs leading to dose modifications or treatment discontinuation

    Timeframe: Up to 228 weeks

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
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
  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • GSK Investigational SitePlantation, United States
  • GSK Investigational SiteAlbuquerque, United States
  • GSK Investigational SiteChattanooga, United States
  • GSK Investigational SiteMorgantown, United States
  • GSK Investigational SiteBuenos Aires, Argentina
  • GSK Investigational SiteCipoletti Rio Negro, Argentina
  • GSK Investigational SiteCiudad Autonoma de Buenos Aire, Argentina
  • GSK Investigational SiteCiudad Autonoma de Buenos Aire, Argentina
  • GSK Investigational SiteFlorida, Argentina
  • GSK Investigational SiteMar del Plata, Argentina
  • GSK Investigational SiteSan Juan, Argentina
  • GSK Investigational SiteSanta Fe, Argentina
  • GSK Investigational SiteWilrijk, Belgium
  • GSK Investigational SiteBarretos, Brazil
  • GSK Investigational SitePorto Alegre, Brazil
  • GSK Investigational SiteSão Paulo, Brazil
  • GSK Investigational SiteVitória, Brazil
  • GSK Investigational SiteOulu, Finland
  • GSK Investigational SiteTampere, Finland
  • GSK Investigational SiteTurku, Finland
  • GSK Investigational SiteVaasa, Finland
  • GSK Investigational SiteBordeaux, France
  • GSK Investigational SiteCaen, France
  • GSK Investigational SiteMarseille, France
  • GSK Investigational SiteQuimper, France

And 74 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2021-005115-32
Sources for references
clinicaltrials.gov

Related records

Drugs (4)

Collaborators (1)

Lead sponsors (1)

Conditions (1)

Targets (1)