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

Status: Recruiting
Location: See all (73) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Loma Linda University
ACTIVE_NOT_RECRUITING
Loma Linda
Kansas
University of Kansas Medical Center
NOT_YET_RECRUITING
Lawrence
Michigan
Henry Ford Health
NOT_YET_RECRUITING
Detroit
Nevada
Comprehensive Cancer Center of Nevada
ACTIVE_NOT_RECRUITING
Las Vegas
Ohio
Gabrail Cancer Center
RECRUITING
Canton
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Virginia
Virginia Cancer Specialists, P.C.
RECRUITING
Fairfax
Other Locations
Argentina
Instituto Médico Especializado Alexander Fleming
NOT_YET_RECRUITING
Buenos Aires
Sanatorio Parque S.A.
NOT_YET_RECRUITING
Santa Fe
Australia
Border Medical Oncology Research Unit
RECRUITING
Albury
Flinders Medical Centre
RECRUITING
Bedford Park
Sunshine Hospital
RECRUITING
St Albans
Latrobe Regional Health
RECRUITING
Traralgon
Austria
Ordensklinikum Linz Elisabethinen
RECRUITING
Linz
Universitatsklinikum St. Poelten
RECRUITING
Sankt Pölten
Medical University of Vienna - Akh
RECRUITING
Vienna
Belgium
Jessa Ziekenhuis
RECRUITING
Hasselt
Uz Leuven Campus Gasthuisberg
RECRUITING
Leuven
Brazil
Hospital de Amor - Barretos
NOT_YET_RECRUITING
Barretos
Supera Oncologia
RECRUITING
Chapecó
CIONC
RECRUITING
Curitiba
ONCOSITE
NOT_YET_RECRUITING
Ijuí
Liga Contra O Cancer - Natal
RECRUITING
Natal
Hospital São Lucas Da Pucrs
RECRUITING
Porto Alegre
Santa Casa de Porto Alegre
RECRUITING
Porto Alegre
Oncoclinicas Rj
RECRUITING
Rio De Janeiro
Hospital A C Camargo
NOT_YET_RECRUITING
São Paulo
Hospital Albert Einstein
NOT_YET_RECRUITING
São Paulo
Hospital São Camilo
RECRUITING
São Paulo
Icesp - Instituto Do Câncer Do Estado de São Paulo
NOT_YET_RECRUITING
São Paulo
Oncoclinicas Sp
RECRUITING
São Paulo
France
Centre Georges Francois Leclerc
RECRUITING
Dijon
Chu Grenoble Alpes
RECRUITING
Grenoble
Institut Paoli Calmette
RECRUITING
Marseille
Centre René Gauducheau/Inst de Cancér. de L'Ouest
RECRUITING
Saint-herblain
Institut Gustave Roussy
NOT_YET_RECRUITING
Villejuif
Hong Kong Special Administrative Region
Hong Kong United Onology Centre
RECRUITING
Hong Kong
Prince of Wales Hospital
RECRUITING
Hong Kong
Queen Mary Hospital
RECRUITING
Hong Kong
Hungary
Farkasgyepu Tudogyogyintezet
NOT_YET_RECRUITING
Farkasgyepű
Bugat Pal Hospital
RECRUITING
Gyöngyös
Pecsi Tudomanyegyetem, Klinikai Kozpont
NOT_YET_RECRUITING
Pécs
Italy
Centro Di Riferimento Oncologico
RECRUITING
Aviano
Inst. Romagnolo Per Lo Studio E La Cura Dei Tumori
RECRUITING
Meldola
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Irccs Fondazione Istituto Nazionale Dei Tumori
RECRUITING
Milan
Istituto Europeo Di Oncologia
RECRUITING
Milan
Ist. Nazionale Tumori Irccs Fondazione G Pascale
RECRUITING
Napoli
Azienda Ospedaliera S. Maria Della Misericordia
RECRUITING
Perugia
Istituto Nazionale Tumori Regina Elena
RECRUITING
Roma
Istituto Clinico Humanitas I.R.C.C.S
RECRUITING
Rozzano
Republic of Korea
Pusan National University Hospital
SUSPENDED
Busan
Chungbuk National University Hospital
SUSPENDED
Cheongju-si
Gacheon University Gil Medical Center
SUSPENDED
Incheon
Korea University Guro Hospital
SUSPENDED
Seoul
Romania
Inst Oncologic Prof Dr I Chiricuta Cluj Napoca
NOT_YET_RECRUITING
Cluj-napoca
Centrul de Oncologie Sf Nectarie
NOT_YET_RECRUITING
Craiova
Centrul de Radioterapie Amethyst
NOT_YET_RECRUITING
Otopeni
Ploiesti Municipal Hospital
NOT_YET_RECRUITING
Ploieşti
Spain
Val de Hebron Institute of Oncology (Vhio), University Hospital
RECRUITING
Barcelona
Clinica Universitaria de Navarra (Madrid)
RECRUITING
Madrid
Hospital General Universitario Gregorio Marañón
RECRUITING
Madrid
Hospital Univ. Hm Sanchinarro Start Ciocc Early Phase
RECRUITING
Madrid
Hospital Universitario Virgen de La Victoria
RECRUITING
Málaga
Clinica Universitaria de Navarra (Pamplona)
RECRUITING
Pamplona
Hospital Virgen Del Rocío
RECRUITING
Seville
Hospital Universitario Y Politecnico La Fe
RECRUITING
Valencia
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Tri-Service General Hospital
RECRUITING
Taipei
United Kingdom
Imperial College London
SUSPENDED
London
The Royal Marsden in Chelsea
NOT_YET_RECRUITING
London
The Royal Marsden in Sutton
NOT_YET_RECRUITING
London
The Christie Nhs Foundation Foundation Trust
RECRUITING
Manchester
Contact Information
Primary
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
scientificinformation@servier.com
+33 1 55 72 60 00
Time Frame
Start Date: 2024-08-07
Estimated Completion Date: 2027-07
Participants
Target number of participants: 176
Treatments
Experimental: S095018 (anti-TIM3 antibody) in combination with cemiplimab
Part A: Combination-therapy safety lead-in
Experimental: S095024 (anti-CD73 antibody) in combination with cemiplimab
Part A: Combination-therapy safety lead-in
Experimental: S095029 (anti-NKG2A antibody) in combination with cemiplimab
Part A: Combination-therapy safety lead-in
Experimental: S095018 (anti-TIM3 antibody) RDE in combination with cemiplimab
Part B: Randomized dose expansion
Experimental: S095024 (anti-CD73 antibody) RDE in combination with cemiplimab
Part B: Randomized dose expansion
Experimental: S095029 (anti-NKG2A antibody) RDE in combination with cemiplimab
Part B: Randomized dose expansion
Active_comparator: Cemiplimab (control arm)
Part B: Randomized dose expansion
Related Therapeutic Areas
Lung Cancer
Non-Small Cell Lung Cancer (NSCLC)
Sponsors
Leads: Servier Bio-Innovation LLC
Collaborators: Regeneron Pharmaceuticals, Institut de Recherches Internationales Servier

This content was sourced from clinicaltrials.gov

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