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Clinical Trials in the UK / NCT06162572
Active, not recruiting Phase 1/2

Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)

NCT06162572 · tracked via the Priya Life Science UK tracker
Sponsor
Servier Bio-Innovation LLC
Phase
Phase 1/2
Started
2024-08-07
Last updated
2026-10-09

Condition(s) studied

Non-small Cell Lung Cancer (NSCLC)

Investigational drug(s) / intervention(s)

S095018S095024S095029 →S095018 Recommended Dose Expansion (RDE)S095024 RDES095029 RDECemiplimab →

S095018: Via IV infusion on Day 1 of each 21-day cycle

S095024: Via IV infusion on Day 1 of each 21-day cycle

S095029: Via IV infusion on Day 1 of each 21-day cycle

S095018 Recommended Dose Expansion (RDE): Via IV infusion on Day 1 of each 21-day cycle

S095024 RDE: Via IV infusion on Day 1 of each 21-day cycle

S095029 RDE: Via IV infusion on Day 1 of each 21-day cycle

Cemiplimab: 350 mg via IV infusion on Day 1 of each 21-day cycle

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence and severity of dose-limiting toxicities (DLTs) during the first 2 cycles of combination treatment — Through the end of the Cycle 2 (each cycle is 21 days)
    Part A
  • Incidence and severity of adverse events (AEs) — From the signed informed consent form (ICF) to 30 days after the last dose
    Part A
  • Incidence and severity of serious adverse events (SAEs) — From the signed ICF to 120 days after the last dose
    Part A
  • Adverse Events (AEs) Leading to Dose Interruption, Modification, or Delays — From signed ICF through treatment discontinuation (up to 108 weeks of treatment)
    Part A
  • Adverse Events (AEs) Leading to Permanent Treatment Discontinuation — From signed ICF through treatment discontinuation (up to 108 weeks of treatment)
    Part A
  • Objective Response (OR) — Until study termination (approximately 2 years)
    Part B: Participants who achieve complete response (CR) or partial response (PR), as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Trial sites (52)

FacilityCityRegionStatus
Henry Ford Health Detroit Michigan
Gabrail Cancer Center Canton Ohio
Ohio State University Comprehensive Cancer Center Columbus Ohio
Border Medical Oncology Research Unit Albury Australia
Flinders Medical Centre Bedford Park Australia
Sunshine Hospital St Albans Australia
Latrobe Regional Health Traralgon Australia
Universitatsklinikum St. Poelten Sankt Pölten Austria
Medical University of Vienna - Akh Vienna Austria
Jessa Ziekenhuis Hasselt Belgium
Uz Leuven Campus Gasthuisberg Leuven Belgium
Hospital de Amor - Barretos Barretos Brazil
Supera Oncologia Chapecó Brazil
CIONC Curitiba Brazil
Liga Contra O Cancer - Natal Natal Brazil
Santa Casa de Porto Alegre Porto Alegre Brazil
Hospital São Lucas Da Pucrs Porto Alegre Brazil
Oncoclinicas Rj Rio de Janeiro Brazil
Hospital A C Camargo São Paulo Brazil
Hospital São Camilo São Paulo Brazil
Oncoclinicas Sp São Paulo Brazil
Hospital Albert Einstein São Paulo Brazil
Centre Georges Francois Leclerc Dijon France
Chu Grenoble Alpes Grenoble France
Institut Paoli Calmette Marseille France
Centre René Gauducheau/Inst de Cancér. de L'Ouest Saint-Herblain France
Institut Gustave Roussy Villejuif France
Queen Mary Hospital Hong Kong Hong Kong
Farkasgyepu Tudogyogyintezet Farkasgyepű Hungary
Bugat Pal Hospital Gyöngyös Hungary
Pecsi Tudomanyegyetem, Klinikai Kozpont Pécs Hungary
Centro Di Riferimento Oncologico Aviano Italy
Inst. Romagnolo Per Lo Studio E La Cura Dei Tumori Meldola Italy
Irccs Fondazione Istituto Nazionale Dei Tumori Milan Italy
Istituto Europeo Di Oncologia Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Ist. Nazionale Tumori Irccs Fondazione G Pascale Naples Italy
Azienda Ospedaliera S. Maria Della Misericordia Perugia Italy
Istituto Nazionale Tumori Regina Elena Roma Italy
Istituto Clinico Humanitas I.R.C.C.S Rozzano Italy

+ 12 more sites — see the full list on the official registry below.

On this site

📄 Libtayo (cemiplimab) drug profile →

More Servier Bio-Innovation LLC trials in the UK

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A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers. Active, not recruiting

Other trials for the same condition

Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations Recruiting
GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors Active, not recruiting
A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202) Recruiting
Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004) Active, not recruiting
A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06162572 on ClinicalTrials.gov ↗ ← All trials in the UK