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

NCT ID: NCT06162572

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-07

Study Completion Date

2027-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer (NSCLC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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S095018 (anti-TIM3 antibody) in combination with cemiplimab

Part A: Combination-therapy safety lead-in

Group Type EXPERIMENTAL

S095018

Intervention Type DRUG

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

Cemiplimab

Intervention Type DRUG

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

S095024 (anti-CD73 antibody) in combination with cemiplimab

Part A: Combination-therapy safety lead-in

Group Type EXPERIMENTAL

S095024

Intervention Type DRUG

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

Cemiplimab

Intervention Type DRUG

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

S095029 (anti-NKG2A antibody) in combination with cemiplimab

Part A: Combination-therapy safety lead-in

Group Type EXPERIMENTAL

S095029

Intervention Type DRUG

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

Cemiplimab

Intervention Type DRUG

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

S095018 (anti-TIM3 antibody) RDE in combination with cemiplimab

Part B: Randomized dose expansion

Group Type EXPERIMENTAL

S095018 Recommended Dose Expansion (RDE)

Intervention Type DRUG

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

Cemiplimab

Intervention Type DRUG

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

S095024 (anti-CD73 antibody) RDE in combination with cemiplimab

Part B: Randomized dose expansion

Group Type EXPERIMENTAL

S095024 RDE

Intervention Type DRUG

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

Cemiplimab

Intervention Type DRUG

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

S095029 (anti-NKG2A antibody) RDE in combination with cemiplimab

Part B: Randomized dose expansion

Group Type EXPERIMENTAL

S095029 RDE

Intervention Type DRUG

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

Cemiplimab

Intervention Type DRUG

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

Cemiplimab (control arm)

Part B: Randomized dose expansion

Group Type ACTIVE_COMPARATOR

Cemiplimab

Intervention Type DRUG

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

Interventions

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S095018

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

Intervention Type DRUG

S095024

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

Intervention Type DRUG

S095029

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

Intervention Type DRUG

S095018 Recommended Dose Expansion (RDE)

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

Intervention Type DRUG

S095024 RDE

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

Intervention Type DRUG

S095029 RDE

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

Intervention Type DRUG

Cemiplimab

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de Recherches Internationales Servier

OTHER

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Servier Bio-Innovation LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Loma Linda University

Loma Linda, California, United States

Site Status ACTIVE_NOT_RECRUITING

University of Kansas Medical Center

Lawrence, Kansas, United States

Site Status WITHDRAWN

Henry Ford Health

Detroit, Michigan, United States

Site Status NOT_YET_RECRUITING

Comprehensive Cancer Center of Nevada

Las Vegas, Nevada, United States

Site Status ACTIVE_NOT_RECRUITING

Gabrail Cancer Center

Canton, Ohio, United States

Site Status RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status RECRUITING

Virginia Cancer Specialists, P.C.

Fairfax, Virginia, United States

Site Status ACTIVE_NOT_RECRUITING

Instituto Médico Especializado Alexander Fleming

Buenos Aires, , Argentina

Site Status RECRUITING

Sanatorio Parque S.A.

Santa Fe, , Argentina

Site Status RECRUITING

Border Medical Oncology Research Unit

Albury, , Australia

Site Status RECRUITING

Flinders Medical Centre

Bedford Park, , Australia

Site Status RECRUITING

Sunshine Hospital

St Albans, , Australia

Site Status RECRUITING

Latrobe Regional Health

Traralgon, , Australia

Site Status RECRUITING

Ordensklinikum Linz Elisabethinen

Linz, , Austria

Site Status RECRUITING

Universitatsklinikum St. Poelten

Sankt Pölten, , Austria

Site Status RECRUITING

Medical University of Vienna - Akh

Vienna, , Austria

Site Status RECRUITING

Jessa Ziekenhuis

Hasselt, , Belgium

Site Status RECRUITING

Uz Leuven Campus Gasthuisberg

Leuven, , Belgium

Site Status RECRUITING

Hospital de Amor - Barretos

Barretos, , Brazil

Site Status RECRUITING

Supera Oncologia

Chapecó, , Brazil

Site Status RECRUITING

CIONC

Curitiba, , Brazil

Site Status RECRUITING

ONCOSITE

Ijuí, , Brazil

Site Status SUSPENDED

Liga Contra O Cancer - Natal

Natal, , Brazil

Site Status RECRUITING

Santa Casa de Porto Alegre

Porto Alegre, , Brazil

Site Status RECRUITING

Hospital São Lucas Da Pucrs

Porto Alegre, , Brazil

Site Status RECRUITING

Oncoclinicas Rj

Rio de Janeiro, , Brazil

Site Status RECRUITING

Icesp - Instituto Do Câncer Do Estado de São Paulo

São Paulo, , Brazil

Site Status SUSPENDED

Hospital A C Camargo

São Paulo, , Brazil

Site Status NOT_YET_RECRUITING

Hospital São Camilo

São Paulo, , Brazil

Site Status RECRUITING

Oncoclinicas Sp

São Paulo, , Brazil

Site Status RECRUITING

Hospital Albert Einstein

São Paulo, , Brazil

Site Status RECRUITING

Centre Georges Francois Leclerc

Dijon, , France

Site Status RECRUITING

Chu Grenoble Alpes

Grenoble, , France

Site Status RECRUITING

Institut Paoli Calmette

Marseille, , France

Site Status RECRUITING

Centre René Gauducheau/Inst de Cancér. de L'Ouest

Saint-Herblain, , France

Site Status RECRUITING

Institut Gustave Roussy

Villejuif, , France

Site Status RECRUITING

Hong Kong United Onology Centre

Hong Kong, , Hong Kong

Site Status RECRUITING

Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Farkasgyepu Tudogyogyintezet

Farkasgyepű, , Hungary

Site Status RECRUITING

Bugat Pal Hospital

Gyöngyös, , Hungary

Site Status RECRUITING

Pecsi Tudomanyegyetem, Klinikai Kozpont

Pécs, , Hungary

Site Status RECRUITING

Centro Di Riferimento Oncologico

Aviano, , Italy

Site Status RECRUITING

Inst. Romagnolo Per Lo Studio E La Cura Dei Tumori

Meldola, , Italy

Site Status RECRUITING

Irccs Fondazione Istituto Nazionale Dei Tumori

Milan, , Italy

Site Status RECRUITING

Istituto Europeo Di Oncologia

Milan, , Italy

Site Status RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Site Status RECRUITING

Ist. Nazionale Tumori Irccs Fondazione G Pascale

Napoli, , Italy

Site Status RECRUITING

Azienda Ospedaliera S. Maria Della Misericordia

Perugia, , Italy

Site Status RECRUITING

Istituto Nazionale Tumori Regina Elena

Roma, , Italy

Site Status RECRUITING

Istituto Clinico Humanitas I.R.C.C.S

Rozzano, , Italy

Site Status RECRUITING

Inst Oncologic "Prof Dr I Chiricuta" Cluj Napoca

Cluj-Napoca, , Romania

Site Status RECRUITING

Centrul de Oncologie Sf Nectarie

Craiova, , Romania

Site Status NOT_YET_RECRUITING

Centrul de Radioterapie Amethyst

Otopeni, , Romania

Site Status NOT_YET_RECRUITING

Ploiesti Municipal Hospital

Ploieşti, , Romania

Site Status RECRUITING

Pusan National University Hospital

Busan, , South Korea

Site Status SUSPENDED

Chungbuk National University Hospital

Cheongju-si, , South Korea

Site Status SUSPENDED

Gacheon University Gil Medical Center

Incheon, , South Korea

Site Status SUSPENDED

Korea University Guro Hospital

Seoul, , South Korea

Site Status SUSPENDED

Vall D' Hebron Institute of Oncology (Vhio), University Hospital

Barcelona, , Spain

Site Status RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status RECRUITING

Clinica Universitaria de Navarra (Madrid)

Madrid, , Spain

Site Status RECRUITING

Hospital Univ. Hm Sanchinarro Start Ciocc Early Phase

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Virgen de La Victoria

Málaga, , Spain

Site Status RECRUITING

Clinica Universitaria de Navarra (Pamplona)

Pamplona, , Spain

Site Status RECRUITING

Hospital Virgen Del Rocío

Seville, , Spain

Site Status RECRUITING

Hospital Universitario Y Politecnico La Fe

Valencia, , Spain

Site Status RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Tri-Service General Hospital

Taipei, , Taiwan

Site Status RECRUITING

The Royal Marsden in Sutton

London, , United Kingdom

Site Status RECRUITING

The Royal Marsden in Chelsea

London, , United Kingdom

Site Status RECRUITING

Imperial College London

London, , United Kingdom

Site Status SUSPENDED

The Christie Nhs Foundation Foundation Trust

Manchester, , United Kingdom

Site Status RECRUITING

Countries

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United States Argentina Australia Austria Belgium Brazil France Hong Kong Hungary Italy Romania South Korea Spain Taiwan United Kingdom

Central Contacts

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Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department

Role: CONTACT

[email protected]
+33 1 55 72 60 00

Other Identifiers

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SPLFIO-174

Identifier Type: -

Identifier Source: org_study_id

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