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

August 10, 2026 updated by: Servier Bio-Innovation LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
  • Phone Number: +33 1 55 72 60 00
  • Email: scientificinformation@servier.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Instituto Médico Especializado Alexander Fleming
      • Santa Fe, Argentina
        • Sanatorio Parque S.A.
  • Australia
      • Albury, Australia, 2640
        • Border Medical Oncology Research Unit
      • Bedford Park, Australia, 5042
        • Flinders Medical Centre
      • St Albans, Australia, 3021
        • Sunshine Hospital
      • Traralgon, Australia, 3844
        • Latrobe Regional Health
  • Austria
      • Linz, Austria, 4020
        • Ordensklinikum Linz Elisabethinen
      • Sankt Pölten, Austria, 3100
        • Universitatsklinikum St. Poelten
      • Vienna, Austria, 1090
        • Medical University of Vienna - Akh
  • Belgium
      • Hasselt, Belgium, 3500
        • Jessa Ziekenhuis
      • Leuven, Belgium, 3500
        • Uz Leuven Campus Gasthuisberg
  • Brazil
      • Barretos, Brazil, 14784-400
        • Hospital de Amor - Barretos
      • Chapecó, Brazil, 89812618
        • Supera Oncologia
      • Curitiba, Brazil, 80810-050
        • CIONC
      • Natal, Brazil, 59035-055
        • Liga Contra O Cancer - Natal
      • Porto Alegre, Brazil, 90020-090
        • Santa Casa de Porto Alegre
      • Porto Alegre, Brazil, 90619-900
        • Hospital São Lucas da PUCRS
      • Rio de Janeiro, Brazil, 22250-905
        • Oncoclinicas Rj
      • São Paulo, Brazil, 01509-010
        • Hospital A C Camargo
      • São Paulo, Brazil, 03102-002
        • Hospital São Camilo
      • São Paulo, Brazil, 04538-132
        • Oncoclinicas Sp
      • São Paulo, Brazil, 05652-900
        • Hospital Albert Einstein
  • France
      • Dijon, France, 21079
        • Centre Georges François Leclerc
      • Grenoble, France, 38043
        • Chu Grenoble Alpes
      • Marseille, France, 13009
        • Institut Paoli Calmette
      • Saint-Herblain, France, 44805
        • Centre René Gauducheau/Inst de Cancér. de L'Ouest
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
  • Hungary
      • Farkasgyepű, Hungary, 8582
        • Farkasgyepu Tudogyogyintezet
      • Gyöngyös, Hungary, 3200
        • Bugat Pal Hospital
      • Pécs, Hungary, 7624
        • Pecsi Tudomanyegyetem, Klinikai Kozpont
  • Italy
      • Aviano, Italy, 33081
        • Centro Di Riferimento Oncologico
      • Meldola, Italy, 47014
        • Inst. Romagnolo Per Lo Studio E La Cura Dei Tumori
      • Milan, Italy, 20141
        • Istituto Europeo Di Oncologia
      • Milan, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda
      • Milan, Italy, 20133
        • Irccs Fondazione Istituto Nazionale Dei Tumori
      • Naples, Italy, 80131
        • Ist. Nazionale Tumori Irccs Fondazione G Pascale
      • Perugia, Italy, 06132
        • Azienda Ospedaliera S. Maria Della Misericordia
      • Roma, Italy, 00144
        • Istituto Nazionale Tumori Regina Elena
      • Rozzano, Italy, 20089
        • Istituto Clinico Humanitas I.R.C.C.S
  • Romania
      • Cluj-Napoca, Romania
        • Inst Oncologic "Prof Dr I Chiricuta" Cluj Napoca
  • Spain
      • Barcelona, Spain, 08035
        • Vall D' Hebron Institute of Oncology (Vhio), University Hospital
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain, 28027
        • Clinica Universitaria de Navarra (Madrid)
      • Madrid, Spain, 28050
        • Hospital Univ. Hm Sanchinarro Start Ciocc Early Phase
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Pamplona, Spain, 31008
        • Clinica Universitaria de Navarra (Pamplona)
      • Valencia, Spain, 46026
        • Hospital Universitario Y Politecnico La Fe
  • Taiwan
      • Taipei, Taiwan, 100225
        • National Taiwan University Hospital
      • Taipei, Taiwan, 114202
        • TRI-Service General Hospital
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden in Chelsea
      • London, United Kingdom, SM2 5PT
        • The Royal Marsden in Sutton
      • Manchester, United Kingdom, M20 4BX
        • The Christie Nhs Foundation Foundation Trust
  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: S095018 (anti-TIM3 antibody) in combination with cemiplimab
Part A: Combination-therapy safety lead-in
Drug: S095018
Via IV infusion on Day 1 of each 21-day cycle
Drug: Cemiplimab
350 mg via IV infusion on Day 1 of each 21-day cycle
Experimental: S095024 (anti-CD73 antibody) in combination with cemiplimab
Part A: Combination-therapy safety lead-in
Drug: Cemiplimab
350 mg via IV infusion on Day 1 of each 21-day cycle
Drug: S095024
Via IV infusion on Day 1 of each 21-day cycle
Experimental: S095029 (anti-NKG2A antibody) in combination with cemiplimab
Part A: Combination-therapy safety lead-in
Drug: Cemiplimab
350 mg via IV infusion on Day 1 of each 21-day cycle
Drug: S095029
Via IV infusion on Day 1 of each 21-day cycle
Experimental: S095018 (anti-TIM3 antibody) RDE in combination with cemiplimab
Part B: Randomized dose expansion
Drug: Cemiplimab
350 mg via IV infusion on Day 1 of each 21-day cycle
Drug: S095018 Recommended Dose Expansion (RDE)
Via IV infusion on Day 1 of each 21-day cycle
Experimental: S095024 (anti-CD73 antibody) RDE in combination with cemiplimab
Part B: Randomized dose expansion
Drug: Cemiplimab
350 mg via IV infusion on Day 1 of each 21-day cycle
Drug: S095024 RDE
Via IV infusion on Day 1 of each 21-day cycle
Experimental: S095029 (anti-NKG2A antibody) RDE in combination with cemiplimab
Part B: Randomized dose expansion
Drug: Cemiplimab
350 mg via IV infusion on Day 1 of each 21-day cycle
Drug: S095029 RDE
Via IV infusion on Day 1 of each 21-day cycle
Active Comparator: Cemiplimab (control arm)
Part B: Randomized dose expansion
Drug: Cemiplimab
350 mg via IV infusion on Day 1 of each 21-day cycle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence and severity of dose-limiting toxicities (DLTs) during the first 2 cycles of combination treatment
Time Frame: Through the end of the Cycle 2 (each cycle is 21 days)
Part A
Through the end of the Cycle 2 (each cycle is 21 days)
Incidence and severity of adverse events (AEs)
Time Frame: From the signed informed consent form (ICF) to 30 days after the last dose
Part A
From the signed informed consent form (ICF) to 30 days after the last dose
Incidence and severity of serious adverse events (SAEs)
Time Frame: From the signed ICF to 120 days after the last dose
Part A
From the signed ICF to 120 days after the last dose
Adverse Events (AEs) Leading to Dose Interruption, Modification, or Delays
Time Frame: From signed ICF through treatment discontinuation (up to 108 weeks of treatment)
Part A
From signed ICF through treatment discontinuation (up to 108 weeks of treatment)
Adverse Events (AEs) Leading to Permanent Treatment Discontinuation
Time Frame: From signed ICF through treatment discontinuation (up to 108 weeks of treatment)
Part A
From signed ICF through treatment discontinuation (up to 108 weeks of treatment)
Objective Response (OR)
Time Frame: Until study termination (approximately 2 years)
Part B: Participants who achieve complete response (CR) or partial response (PR), as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Until study termination (approximately 2 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response (OR)
Time Frame: Until study termination (approximately 3 years)
Part A: Participants who achieve CR or PR, as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune RECIST (iRECIST) as assessed by the investigator.
Until study termination (approximately 3 years)
Best Overall Response (BOR)
Time Frame: Until study termination (approximately 3 years)
Part A and B: The best response designation using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune RECIST (iRECIST), recorded between the date of the first dose of treatment and the date of the first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first. CR or PR used in the BOR requires a confirmation that is at least 4 weeks apart.
Until study termination (approximately 3 years)
Duration of Response (DoR)
Time Frame: Until study termination (approximately 3 years)
Part A and B: The time from the first documentation of CR or PR until the documented progressive disease (PD) or death, as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune RECIST (iRECIST) as assessed by the investigator.
Until study termination (approximately 3 years)
Disease Control (DC)
Time Frame: Until study termination (approximately 3 years)
Part A and B: Participants who achieved stable disease (SD), PR, or CR (based on participant's best response), as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune RECIST (iRECIST) as assessed by the investigator.
Until study termination (approximately 3 years)
6-month Durable Response (6-month DR)
Time Frame: Until study termination (approximately 3 years)
Part A and B: Continuous CR or PR for ≥ 6 months, recorded between the date of the first dose of treatment and the date of the first objectively documented progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or the date of subsequent anti-cancer therapy, whichever occurs first.
Until study termination (approximately 3 years)
Progression-Free Survival (PFS)
Time Frame: Until study termination (approximately 3 years)
Part A and B: The time from the first dose to the first documented PD or death due to any cause, whichever occurs first, as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune RECIST (iRECIST) as assessed by the investigator.
Until study termination (approximately 3 years)
Plasma or serum concentration of S095018
Time Frame: From first dose to 30 days after the last dose
Part A and B
From first dose to 30 days after the last dose
Plasma or serum concentration of S095024
Time Frame: From first dose to 30 days after the last dose
Part A and B
From first dose to 30 days after the last dose
Plasma or serum concentration of S095029
Time Frame: From first dose to 30 days after the last dose
Part A and B
From first dose to 30 days after the last dose
Incidence and titer of anti-drug antibodies (ADA) directed against S095018
Time Frame: From screening to 90 days after the last dose
Part A and B
From screening to 90 days after the last dose
Incidence and titer of anti-drug antibodies (ADA) directed against S095024
Time Frame: From screening to 90 days after the last dose
Part A and B
From screening to 90 days after the last dose
Incidence and titer of anti-drug antibodies (ADA) directed against S095029
Time Frame: From screening to 90 days after the last dose
Part A and B
From screening to 90 days after the last dose
Incidence and severity of adverse events (AEs)
Time Frame: From signed ICF to 30 days after the last dose
Part B
From signed ICF to 30 days after the last dose
Incidence and severity of serious adverse events (SAEs)
Time Frame: From signed ICF to 120 days after the last dose
Part B
From signed ICF to 120 days after the last dose
Adverse Events (AEs) Leading to Dose Interruption, Modification, or Delays
Time Frame: From signed ICF through treatment discontinuation (up to 108 weeks of treatment)
Part B
From signed ICF through treatment discontinuation (up to 108 weeks of treatment)
Adverse Events (AEs) Leading to Permanent Treatment Discontinuation
Time Frame: From signed ICF through treatment discontinuation (up to 108 weeks of treatment)
Part B
From signed ICF through treatment discontinuation (up to 108 weeks of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Servier Bio-Innovation LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Regeneron Pharmaceuticals
Institut de Recherches Internationales Servier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPLFIO-174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

  • used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

  • sponsored by Servier
  • with a first patient enrolled as of 1 January 2004 onwards
  • for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

IPD Sharing Time Frame

After Marketing Authorization in EEA or US if the study is used for the approval.

IPD Sharing Access Criteria

Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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