Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) (NCT06162572)
A Phase 1b/2, 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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Henry Ford Health — Detroit, Michigan
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (56 Sites)
Showing the first 25 of 56 sites.
- Henry Ford Health — Detroit, Michigan
- Gabrail Cancer Center — Canton, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio
- Instituto Médico Especializado Alexander Fleming — Buenos Aires,
- Sanatorio Parque S.A. — Santa Fe,
- Border Medical Oncology Research Unit — Albury,
- Flinders Medical Centre — Bedford Park,
- Sunshine Hospital — St Albans,
- Latrobe Regional Health — Traralgon,
- Ordensklinikum Linz Elisabethinen — Linz,
- Universitatsklinikum St. Poelten — Sankt Pölten,
- Medical University of Vienna - Akh — Vienna,
- Jessa Ziekenhuis — Hasselt,
- Uz Leuven Campus Gasthuisberg — Leuven,
- Hospital de Amor - Barretos — Barretos,
- Supera Oncologia — Chapecó,
- CIONC — Curitiba,
- Liga Contra O Cancer - Natal — Natal,
- Santa Casa de Porto Alegre — Porto Alegre,
- Hospital São Lucas Da Pucrs — Porto Alegre,
- Oncoclinicas Rj — Rio de Janeiro,
- Hospital A C Camargo — São Paulo,
- Hospital São Camilo — São Paulo,
- Oncoclinicas Sp — São Paulo,
- Hospital Albert Einstein — São Paulo,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer — Santa Monica, California
- PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung — Tampa, Florida
- U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer — Duarte, California
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Explore by condition: All Non-small Cell Lung Cancer (NSCLC) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.