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Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)
Sponsor: Servier Bio-Innovation LLC
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.
Official title: A Phase 1b/2, Multicenter, Open-label Platform Study of Select Immunotherapy Combinations in Adult Participants With Previously Untreated Advanced Non-small Cell Lung Cancer (NSCLC) With High PD-L1 Expression
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
101
Start Date
2024-08-07
Completion Date
2027-07
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
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
Locations (63)
Loma Linda University
Loma Linda, California, United States
Henry Ford Health
Detroit, Michigan, United States
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, United States
Gabrail Cancer Center
Canton, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Virginia Cancer Specialists, P.C.
Fairfax, Virginia, United States
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
Hong Kong United Onology Centre
Hong Kong, Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
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
Inst Oncologic "Prof Dr I Chiricuta" Cluj Napoca
Cluj-Napoca, Romania
Ploiesti Municipal Hospital
Ploieşti, Romania
Vall D' Hebron Institute of Oncology (Vhio), University Hospital
Barcelona, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Clinica Universitaria de Navarra (Madrid)
Madrid, Spain
Hospital Univ. Hm Sanchinarro Start Ciocc Early Phase
Madrid, Spain
Hospital Universitario Virgen de La Victoria
Málaga, Spain
Clinica Universitaria de Navarra (Pamplona)
Pamplona, Spain
Hospital Virgen Del Rocío
Seville, Spain
Hospital Universitario Y Politecnico La Fe
Valencia, Spain
National Taiwan University Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
The Royal Marsden in Sutton
London, United Kingdom
The Royal Marsden in Chelsea
London, United Kingdom
The Christie Nhs Foundation Foundation Trust
Manchester, United Kingdom