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 Australia tracker

Sponsor

Servier Bio-Innovation LLC

Phase

Phase 1/2

Started

2024-08-07

Last updated

2026-08-11

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

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 (56)

Facility	City	Region
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	Argentina
Sanatorio Parque S.A.	Santa Fe	Argentina
Border Medical Oncology Research Unit	Albury	Australia
Flinders Medical Centre	Bedford Park	Australia
Sunshine Hospital	St Albans	Australia
Latrobe Regional Health	Traralgon	Australia
Ordensklinikum Linz Elisabethinen	Linz	Austria
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

+ 16 more sites — see the full list on the official registry below.

On this site

📄 Libtayo (cemiplimab) drug profile →

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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 Australia