A Phase Ib/II, Multicenter, Open-label Platform Study of Select Immunotherapy Combinations in Adult Participants With Previously Untreated Advanced Non-small Cell Lung Cancer (NSCLC) With High PD-L1 Expression

Study Identifier:
SPLFIO-174
CT.gov Identifier:
NCT06162572
EudraCT Identifier:
202351000000
EU Trial (CTIS) Number:
2023-508730-34-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

Considering participating in a START clinical trial?

Get Started

Study Summary

This is a Phase 1b/2 study evaluating the anti-PD1 antibody, cemiplimab, in combination with either S095018 (anti-TIM3 antibody), S095024 (anti-CD73 antibody), or S095029 (anti-NKG2A antibody) in adult participants with previously untreated advanced/metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression. The study includes two parts: part A, the combination-therapy safety lead-in phase to determine the recommended dose for expansion (RDE) for S095018, S095024, and S095029 in combination with cemiplimab and part B, the randomized dose expansion phase to assess the efficacy of S095018, S095024, or S095029 in combination with cemiplimab. Study treatment will be administered for a maximum of 108 weeks, or until confirmed disease progression per iRECIST and/ or until meeting other treatment discontinuation criteria.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Non-Small Cell Lung Cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18 - 64 Years
    Study Drug
    N/A
    Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • - Adult patient aged ≥ 18 years
    • - Written informed consent
    • - Histologically (squamous or non-squamous) or cytologically documented locally advanced
    • NSCLC not eligible for surgical resection and/or definitive chemoradiation, or
    • metastatic NSCLC
    • - No prior systemic treatment for locally advanced or metastatic NSCLC
    • - High tumor cell PD-L1 expression [Tumor Proportion Score (TPS) ≥50%] based on
    • documented status as determined by an approved test
    • - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
    • - Measurable disease as determined by RECIST v1.1
    Exclusion criteria
    • Tumors harboring driver mutations/genetic aberrations for which targeted therapies are approved as frontline treatment (e.g. EGFR mutation, ALK fusion oncogene, ROS1 aberrations)
    • Prior immune checkpoint inhibitor therapy
    • Active brain metastases
    • Participants with active and uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
    • Uncontrolled HIV infection. Participants with HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are allowed to enroll
    • Active, known or suspected autoimmune disease or immune deficiency
    • History of hypersensitivity reactions to any ingredient of the investigational medicinal product (IMP) and other monoclonal antibody (mAbs) and/or their excipients
    • History of interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis or active pneumonitis ≥ grade 2
    • History of inflammatory bowel disease or colitis ≥ grade 2
    • History of hemophagocytic lymphohistiocytosis.
    • Systemic chronic steroid therapy (>10mg/d prednisone or equivalent)
    • Clinically significant infection, as assessed by the investigator
    • Pregnant or breast-feeding (lactating) women
    • Participants with a history of allogeneic organ transplantation (e.g., stem cell or solid organ transplant)
    • Any medical condition that would in the investigator's judgement prevent the participant's participation in the clinical study

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Juan José Soto
    Status
    Recruitment on Hold
    Condition(s) Treated at Site
    Non-Small Cell Lung Cancer