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

Last updated: March 13, 2025
Sponsor: Servier Bio-Innovation LLC
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

Cemiplimab

S095029 RDE

S095018

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)

  • Active infection, including infection requiring systemic antibiotic therapy

  • 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: 176
Treatment Group(s): 7
Primary Treatment: Cemiplimab
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

    Ciudad Autonoma de Buenos Aires,
    Argentina

    Site Not Available

  • Sanatorio Parque S.A.

    Santa Fe,
    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

    Active - Recruiting

  • Flinders Medical Centre

    Bedford Park, 5042
    Australia

    Active - Recruiting

  • Sunshine Hospital

    St Albans, 3021
    Australia

    Active - Recruiting

  • Latrobe Regional Health

    Traralgon, 3844
    Australia

    Active - Recruiting

  • Ordensklinikum Linz Elisabethinen

    Linz, 4020
    Austria

    Active - Recruiting

  • Universitatsklinikum St. Poelten

    St. Poelten, 3100
    Austria

    Active - Recruiting

  • Medical University of Vienna - Akh

    Wien, 1090
    Austria

    Active - Recruiting

  • Jessa Ziekenhuis

    Hasselt, 3500
    Belgium

    Site Not Available

  • Uz Leuven Campus Gasthuisberg

    Leuven, 3500
    Belgium

    Site Not Available

  • Hospital de Amor - Barretos

    Barretos, 14784-400
    Brazil

    Site Not Available

  • Supera Oncologia

    Chapecó, 89812618
    Brazil

    Active - Recruiting

  • CIONC

    Curitiba, 80810-050
    Brazil

    Active - Recruiting

  • ONCOSITE

    Ijuí, 98700-000
    Brazil

    Site Not Available

  • Liga Contra O Cancer - Natal

    Natal, 59035-055
    Brazil

    Active - Recruiting

  • Hospital São Lucas Da Pucrs

    Porto Alegre, 90619-900
    Brazil

    Active - Recruiting

  • Santa Casa de Porto Alegre

    Porto Alegre, 90020-090
    Brazil

    Site Not Available

  • Oncoclinicas Rj

    Rio De Janeiro, 22250-905
    Brazil

    Active - Recruiting

  • 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

  • Centre Georges Francois Leclerc

    Dijon, 21079
    France

    Active - Recruiting

  • Chu Grenoble Alpes

    Grenoble, 38043
    France

    Site Not Available

  • Institut Paoli Calmette

    Marseille, 13009
    France

    Active - Recruiting

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

    Saint-Herblain, 44805
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • Hong Kong United Onology Centre

    Hong Kong,
    Hong Kong

    Site Not Available

  • Prince of Wales Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Queen Marry Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Queen Mary Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

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

    Hong Kong,
    Hong Kong

    Site Not Available

  • Farkasgyepu Tudogyogyintezet

    Farkasgyepű, 8582
    Hungary

    Site Not Available

  • Bugat Pal Hospital

    Gyöngyös, 3200
    Hungary

    Active - Recruiting

  • Pecsi Tudomanyegyetem, Klinikai Kozpont

    Pécs, 7624
    Hungary

    Site Not Available

  • Centro Di Riferimento Oncologico

    Aviano, 33081
    Italy

    Active - Recruiting

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

    Meldola, 47014
    Italy

    Active - Recruiting

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

    Milano, 20162
    Italy

    Active - Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Active - Recruiting

  • Irccs Fondazione Istituto Nazionale Dei Tumori

    Milano, 20133
    Italy

    Site Not Available

  • Istituto Europeo Di Oncologia

    Milano, 20141
    Italy

    Active - Recruiting

  • Ist. Nazionale Tumori Irccs Fondazione G Pascale

    Napoli, 80131
    Italy

    Active - Recruiting

  • Azienda Ospedaliera S. Maria Della Misericordia

    Perugia, 06132
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144
    Italy

    Active - Recruiting

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

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Pusan National University Hospital

    Busan, 49241
    Korea, Republic of

    Suspended

  • Chungbuk National University Hospital

    Cheongju-si, 28644
    Korea, Republic of

    Suspended

  • Gacheon University Gil Medical Center

    Incheon, 21565
    Korea, Republic of

    Suspended

  • Korea University Guro Hospital

    Seoul, 08308
    Korea, Republic of

    Suspended

  • Inst Oncologic "Prof Dr I Chiricuta" Cluj Napoca

    Cluj-Napoca,
    Romania

    Site Not Available

  • Centrul de Oncologie Sf Nectarie

    Craiova,
    Romania

    Site Not Available

  • Centrul de Radioterapie Amethyst

    Otopeni,
    Romania

    Site Not Available

  • Ploiesti Municipal Hospital

    Ploieşti,
    Romania

    Site Not Available

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

    Barcelona, 08035
    Spain

    Active - Recruiting

  • 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

    Active - Recruiting

  • Hospital Univ. Hm Sanchinarro Start Ciocc Early Phase

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital Regional Universitario (Carlos Haya)

    Málaga, 29010
    Spain

    Site Not Available

  • Hospital Universitario Virgen de La Victoria

    Málaga, 29010
    Spain

    Active - Recruiting

  • Clinica Universitaria de Navarra (Pamplona

    Pamplona, 31008
    Spain

    Site Not Available

  • Clinica Universitaria de Navarra (Pamplona)

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de La Victoria

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Virgen Del Rocío

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Y Politecnico La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 100225
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei, 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

  • The Christie Nhs Foundation Foundation Trust

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Loma Linda University

    Loma Linda, California 92354
    United States

    Site Not Available

  • University of Kansas Medical Center

    Lawrence, Kansas 66160
    United States

    Site Not Available

  • Henry Ford Health

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Comprehensive Cancer Center of Nevada

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Gabrail Cancer Center

    Canton, Ohio 44718
    United States

    Active - Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Virginia Cancer Specialists, P.C.

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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