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

Last updated: February 11, 2026
Sponsor: Servier Bio-Innovation LLC
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

N/A

Treatment

S095024

S095018 Recommended Dose Expansion (RDE)

Cemiplimab

Clinical Study ID

NCT06162572
SPLFIO-174
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Adult patient aged ≥ 18 years

  • Written informed consent

  • Histologically (squamous or non-squamous) or cytologically documented locallyadvanced 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 ondocumented 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

Exclusion Criteria:

  • Tumors harboring driver mutations/genetic aberrations for which targeted therapiesare approved as frontline treatment (e.g. EGFR mutation, ALK fusion oncogene, ROS1aberrations)

  • Prior immune checkpoint inhibitor therapy

  • Active brain metastases

  • Participants with active and uncontrolled hepatitis B virus (HBV) or hepatitis Cvirus (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 stableantiviral regimen) are allowed to enroll

  • Active, known or suspected autoimmune disease or immune deficiency

  • History of hypersensitivity reactions to any ingredient of the investigationalmedicinal product (IMP) and other monoclonal antibody (mAbs) and/or their excipients

  • History of interstitial lung disease, idiopathic pulmonary fibrosis, drug-inducedpneumonitis, 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 orsolid organ transplant)

  • Any medical condition that would in the investigator's judgement prevent theparticipant's participation in the clinical study

Study Design

Total Participants: 74
Treatment Group(s): 7
Primary Treatment: S095024
Phase: 1/2
Study Start date:
August 07, 2024
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • Instituto Médico Especializado Alexander Fleming

    Buenos Aires,
    Argentina

    Site Not Available

  • Instituto Médico Especializado Alexander Fleming

    Buenos Aires 3435910,
    Argentina

    Site Not Available

  • Instituto Médico Especializado Alexander Fleming

    Ciudad Autonoma de Buenos Aires,
    Argentina

    Site Not Available

  • Sanatorio Parque S.A.

    Santa Fe,
    Argentina

    Site Not Available

  • Sanatorio Parque S.A.

    Santa Fe 3836277,
    Argentina

    Site Not Available

  • Sanatorio Parque S.A.

    Tucumán,
    Argentina

    Site Not Available

  • Albury Wodonga Regional Cancer Centre; Border Medical Oncology Research Unit

    Albury, 2640
    Australia

    Active - Recruiting

  • Border Medical Oncology Research Unit

    Albury, 2640
    Australia

    Site Not Available

  • Border Medical Oncology Research Unit

    Albury 2178174, 2640
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park, 5042
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park 2076918, 5042
    Australia

    Site Not Available

  • Sunshine Hospital

    St Albans, 3021
    Australia

    Site Not Available

  • Sunshine Hospital

    St Albans 8015209, 3021
    Australia

    Site Not Available

  • Latrobe Regional Health

    Traralgon, 3844
    Australia

    Site Not Available

  • Latrobe Regional Health

    Traralgon 2146108, 3844
    Australia

    Site Not Available

  • Ordensklinikum Linz Elisabethinen

    Linz, 4020
    Austria

    Site Not Available

  • Ordensklinikum Linz Elisabethinen

    Linz 2772400, 4020
    Austria

    Site Not Available

  • Universitatsklinikum St. Poelten

    Sankt Pölten 2766429, 3100
    Austria

    Site Not Available

  • Universitatsklinikum St. Poelten

    St. Poelten, 3100
    Austria

    Site Not Available

  • Medical University of Vienna - Akh

    Vienna 2761369, 1090
    Austria

    Site Not Available

  • Medical University of Vienna - Akh

    Wien, 1090
    Austria

    Site Not Available

  • Jessa Ziekenhuis

    Hasselt, 3500
    Belgium

    Site Not Available

  • Jessa Ziekenhuis

    Hasselt 2796491, 3500
    Belgium

    Site Not Available

  • Uz Leuven Campus Gasthuisberg

    Leuven, 3500
    Belgium

    Site Not Available

  • Uz Leuven Campus Gasthuisberg

    Leuven 2792482, 3500
    Belgium

    Site Not Available

  • Hospital de Amor - Barretos

    Barretos, 14784-400
    Brazil

    Site Not Available

  • Hospital de Amor - Barretos

    Barretos 3470451, 14784-400
    Brazil

    Site Not Available

  • Supera Oncologia

    Chapecó, 89812618
    Brazil

    Site Not Available

  • Supera Oncologia

    Chapecó 3466296, 89812618
    Brazil

    Site Not Available

  • CIONC

    Curitiba, 80810-050
    Brazil

    Site Not Available

  • CIONC

    Curitiba 3464975, 80810-050
    Brazil

    Site Not Available

  • ONCOSITE

    Ijuí, 98700-000
    Brazil

    Site Not Available

  • ONCOSITE

    Ijuí 3461444, 98700-000
    Brazil

    Site Not Available

  • Liga Contra O Cancer - Natal

    Natal, 59035-055
    Brazil

    Site Not Available

  • Liga Contra O Cancer - Natal

    Natal 3394023, 59035-055
    Brazil

    Site Not Available

  • Hospital São Lucas Da Pucrs

    Porto Alegre, 90619-900
    Brazil

    Site Not Available

  • Santa Casa de Porto Alegre

    Porto Alegre, 90020-090
    Brazil

    Active - Recruiting

  • Hospital São Lucas Da Pucrs

    Porto Alegre 3452925, 90619-900
    Brazil

    Site Not Available

  • Santa Casa de Porto Alegre

    Porto Alegre 3452925, 90020-090
    Brazil

    Site Not Available

  • Oncoclinicas Rj

    Rio De Janeiro, 22250-905
    Brazil

    Site Not Available

  • Oncoclinicas Rj

    Rio de Janeiro 3451190, 22250-905
    Brazil

    Site Not Available

  • Hospital A C Camargo

    São Paulo, 01509-010
    Brazil

    Site Not Available

  • Hospital Albert Einstein

    São Paulo, 05652-900
    Brazil

    Site Not Available

  • Hospital São Camilo

    São Paulo, 03102-002
    Brazil

    Active - Recruiting

  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    São Paulo, 01246-000
    Brazil

    Site Not Available

  • Oncoclinicas Sp

    São Paulo, 04538-132
    Brazil

    Active - Recruiting

  • Hospital A C Camargo

    São Paulo 3448439, 01509-010
    Brazil

    Site Not Available

  • Hospital Albert Einstein

    São Paulo 3448439, 05652-900
    Brazil

    Site Not Available

  • Hospital São Camilo

    São Paulo 3448439, 03102-002
    Brazil

    Site Not Available

  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    São Paulo 3448439, 01246-000
    Brazil

    Suspended

  • Oncoclinicas Sp

    São Paulo 3448439, 04538-132
    Brazil

    Site Not Available

  • Centre Georges Francois Leclerc

    Dijon, 21079
    France

    Site Not Available

  • Centre Georges Francois Leclerc

    Dijon 3021372, 21079
    France

    Site Not Available

  • Chu Grenoble Alpes

    Grenoble, 38043
    France

    Site Not Available

  • Chu Grenoble Alpes

    Grenoble 3014728, 38043
    France

    Site Not Available

  • Institut Paoli Calmette

    Marseille, 13009
    France

    Site Not Available

  • Institut Paoli Calmette

    Marseille 2995469, 13009
    France

    Site Not Available

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

    Saint-Herblain, 44805
    France

    Site Not Available

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

    Saint-Herblain 2979590, 44805
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif 2968705, 94805
    France

    Site Not Available

  • Hong Kong United Onology Centre

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Prince of Wales Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Queen Marry Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Queen Mary Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Sir Yue Kong Pao Centre for Cancer; Prince of Wales Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Hong Kong United Onology Centre

    Hong Kong 1819729,
    Hong Kong

    Site Not Available

  • Prince of Wales Hospital

    Hong Kong 1819729,
    Hong Kong

    Site Not Available

  • Queen Mary Hospital

    Hong Kong 1819729,
    Hong Kong

    Site Not Available

  • Farkasgyepu Tudogyogyintezet

    Farkasgyepű, 8582
    Hungary

    Site Not Available

  • Farkasgyepu Tudogyogyintezet

    Farkasgyepű 3053094, 8582
    Hungary

    Site Not Available

  • Bugat Pal Hospital

    Gyöngyös, 3200
    Hungary

    Site Not Available

  • Bugat Pal Hospital

    Gyöngyös 3052040, 3200
    Hungary

    Site Not Available

  • Pecsi Tudomanyegyetem, Klinikai Kozpont

    Pécs, 7624
    Hungary

    Site Not Available

  • Pecsi Tudomanyegyetem, Klinikai Kozpont

    Pécs 3046526, 7624
    Hungary

    Site Not Available

  • Centro Di Riferimento Oncologico

    Aviano, 33081
    Italy

    Site Not Available

  • Centro Di Riferimento Oncologico

    Aviano 3182635, 33081
    Italy

    Site Not Available

  • Inst. Romagnolo Per Lo Studio E La Cura Dei Tumori

    Meldola, 47014
    Italy

    Site Not Available

  • Inst. Romagnolo Per Lo Studio E La Cura Dei Tumori

    Meldola 3173635, 47014
    Italy

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan 6951411, 20162
    Italy

    Site Not Available

  • Irccs Fondazione Istituto Nazionale Dei Tumori

    Milan 6951411, 20133
    Italy

    Site Not Available

  • Istituto Europeo Di Oncologia

    Milan 6951411, 20141
    Italy

    Site Not Available

  • A.O. Ospedale Niguarda Ca' Granda-Milano

    Milano, 20162
    Italy

    Active - Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Site Not Available

  • Irccs Fondazione Istituto Nazionale Dei Tumori

    Milano, 20133
    Italy

    Active - Recruiting

  • Istituto Europeo Di Oncologia

    Milano, 20141
    Italy

    Active - Recruiting

  • Ist. Nazionale Tumori Irccs Fondazione G Pascale

    Napoli, 80131
    Italy

    Site Not Available

  • Ist. Nazionale Tumori Irccs Fondazione G Pascale

    Napoli 9031661, 80131
    Italy

    Site Not Available

  • Azienda Ospedaliera S. Maria Della Misericordia

    Perugia, 06132
    Italy

    Site Not Available

  • Azienda Ospedaliera S. Maria Della Misericordia

    Perugia 3171180, 06132
    Italy

    Site Not Available

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144
    Italy

    Site Not Available

  • Istituto Nazionale Tumori Regina Elena

    Roma 8957247, 00144
    Italy

    Site Not Available

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

    Rozzano, 20089
    Italy

    Site Not Available

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

    Rozzano 3168837, 20089
    Italy

    Site Not Available

  • Pusan National University Hospital

    Busan, 49241
    Korea, Republic of

    Site Not Available

  • Chungbuk National University Hospital

    Cheongju-si, 28644
    Korea, Republic of

    Site Not Available

  • Gacheon University Gil Medical Center

    Incheon, 21565
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul, 08308
    Korea, Republic of

    Site Not Available

  • Inst Oncologic "Prof Dr I Chiricuta" Cluj Napoca

    Cluj-Napoca,
    Romania

    Site Not Available

  • Inst Oncologic "Prof Dr I Chiricuta" Cluj Napoca

    Cluj-Napoca 681290,
    Romania

    Site Not Available

  • Centrul de Oncologie Sf Nectarie

    Craiova,
    Romania

    Site Not Available

  • Centrul de Oncologie Sf Nectarie

    Craiova 680332,
    Romania

    Site Not Available

  • Centrul de Radioterapie Amethyst

    Otopeni,
    Romania

    Site Not Available

  • Centrul de Radioterapie Amethyst

    Otopeni 671590,
    Romania

    Site Not Available

  • Ploiesti Municipal Hospital

    Ploieşti,
    Romania

    Site Not Available

  • Ploiesti Municipal Hospital

    Ploieşti 670474,
    Romania

    Site Not Available

  • Pusan National University Hospital

    Busan 1838524, 49241
    South Korea

    Site Not Available

  • Chungbuk National University Hospital

    Cheongju-si 1845604, 28644
    South Korea

    Site Not Available

  • Gacheon University Gil Medical Center

    Incheon 1843564, 21565
    South Korea

    Site Not Available

  • Korea University Guro Hospital

    Seoul 1835848, 08308
    South Korea

    Site Not Available

  • Val de Hebron Institute of Oncology (Vhio), University Hospital

    Barcelona, 08035
    Spain

    Site Not Available

  • Val de Hebron Institute of Oncology (Vhio), University Hospital

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

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

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Clinica Universitaria de Navarra (Madrid)

    Madrid, 28027
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Univ. Hm Sanchinarro Start Ciocc Early Phase

    Madrid, 28050
    Spain

    Active - Recruiting

  • Clinica Universitaria de Navarra (Madrid)

    Madrid 3117735, 28027
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañón

    Madrid 3117735, 28007
    Spain

    Site Not Available

  • Hospital Univ. Hm Sanchinarro Start Ciocc Early Phase

    Madrid 3117735, 28050
    Spain

    Site Not Available

  • Hospital Regional Universitario (Carlos Haya)

    Málaga, 29010
    Spain

    Site Not Available

  • Hospital Universitario Virgen de La Victoria

    Málaga, 29010
    Spain

    Site Not Available

  • Hospital Universitario Virgen de La Victoria

    Málaga 2514256, 29010
    Spain

    Site Not Available

  • Clinica Universitaria de Navarra (Pamplona

    Pamplona, 31008
    Spain

    Site Not Available

  • Clinica Universitaria de Navarra (Pamplona)

    Pamplona, 31008
    Spain

    Site Not Available

  • Clinica Universitaria de Navarra (Pamplona)

    Pamplona 3114472, 31008
    Spain

    Site Not Available

  • Hospital Universitario Virgen de La Victoria

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Virgen Del Rocío

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Virgen Del Rocío

    Seville 2510911, 41013
    Spain

    Site Not Available

  • Hospital Universitario Y Politecnico La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Universitario Y Politecnico La Fe

    Valencia 2509954, 46026
    Spain

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 100225
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei, 114202
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei 1668341, 100225
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei 1668341, 114202
    Taiwan

    Site Not Available

  • Imperial College London

    London, SW7 2BX
    United Kingdom

    Suspended

  • The Royal Marsden in Chelsea

    London, SW3 6JJ
    United Kingdom

    Site Not Available

  • The Royal Marsden in Sutton

    London, SM2 5PT
    United Kingdom

    Site Not Available

  • Imperial College London

    London 2643743, SW7 2BX
    United Kingdom

    Suspended

  • The Royal Marsden in Chelsea

    London 2643743, SW3 6JJ
    United Kingdom

    Site Not Available

  • The Royal Marsden in Sutton

    London 2643743, SM2 5PT
    United Kingdom

    Site Not Available

  • The Christie Nhs Foundation Foundation Trust

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • The Christie Nhs Foundation Foundation Trust

    Manchester 2643123, M20 4BX
    United Kingdom

    Site Not Available

  • Loma Linda University

    Loma Linda, California 92354
    United States

    Site Not Available

  • Loma Linda University

    Loma Linda 5367696, California 5332921 92354
    United States

    Site Not Available

  • University of Kansas Medical Center

    Lawrence, Kansas 66160
    United States

    Site Not Available

  • University of Kansas Medical Center

    Lawrence 4274277, Kansas 4273857 66160
    United States

    Site Not Available

  • Henry Ford Health

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Henry Ford Health

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

  • Comprehensive Cancer Center of Nevada

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Comprehensive Cancer Center of Nevada

    Las Vegas 5506956, Nevada 5509151 89119
    United States

    Site Not Available

  • Gabrail Cancer Center

    Canton, Ohio 44718
    United States

    Site Not Available

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Gabrail Cancer Center

    Canton 5149222, Ohio 5165418 44718
    United States

    Site Not Available

  • Ohio State University Comprehensive Cancer Center

    Columbus 4509177, Ohio 5165418 43210
    United States

    Site Not Available

  • Virginia Cancer Specialists, P.C.

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Virginia Cancer Specialists, P.C.

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

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