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Non-small Cell Lung Cancer (NSCLC)Phase 1/2NCT06162572

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

A Phase 1/2 study testing S095018, S095024 and S095029 in people with Non-small Cell Lung Cancer (NSCLC), run by Servier Bio-Innovation LLC at 52 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer (NSCLC)
What is being tested?
S095018, S095024 and S095029
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
52 sitesin 13 countries
Study dates
7 Aug 2024to Jul 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

52 sites in 13 countries.

52 sites in 13 countries

Brazil11 sites

  • Hospital de Amor - Barretos

    Barretos, 14784-400

  • Supera Oncologia

    Chapecó, 89812618

  • CIONC

    Curitiba, 80810-050

  • Liga Contra O Cancer - Natal

    Natal, 59035-055

  • Santa Casa de Porto Alegre

    Porto Alegre, 90020-090

  • Hospital São Lucas Da Pucrs

    Porto Alegre, 90619-900

  • Oncoclinicas Rj

    Rio de Janeiro, 22250-905

  • Hospital A C Camargo

    São Paulo, 01509-010

  • Hospital São Camilo

    São Paulo, 03102-002

  • Oncoclinicas Sp

    São Paulo, 04538-132

  • Hospital Albert Einstein

    São Paulo, 05652-900

Other trials in Brazil

Italy9 sites

  • Centro Di Riferimento Oncologico

    Aviano, 33081

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

    Meldola, 47014

  • Irccs Fondazione Istituto Nazionale Dei Tumori

    Milan, 20133

  • Istituto Europeo Di Oncologia

    Milan, 20141

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Ist. Nazionale Tumori Irccs Fondazione G Pascale

    Naples, 80131

  • Azienda Ospedaliera S. Maria Della Misericordia

    Perugia, 06132

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144

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

    Rozzano, 20089

Other trials in Italy

Spain6 sites

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

    Barcelona, 08035

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Clinica Universitaria de Navarra (Madrid)

    Madrid, 28027

  • Hospital Univ. Hm Sanchinarro Start Ciocc Early Phase

    Madrid, 28050

  • Hospital Universitario Virgen de La Victoria

    Málaga, 29010

  • Hospital Universitario Y Politecnico La Fe

    Valencia, 46026

Other trials in Spain

France5 sites

  • Centre Georges Francois Leclerc

    Dijon, 21079

  • Chu Grenoble Alpes

    Grenoble, 38043

  • Institut Paoli Calmette

    Marseille, 13009

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

    Saint-Herblain, 44805

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Australia4 sites

  • Border Medical Oncology Research Unit

    Albury, 2640

  • Flinders Medical Centre

    Bedford Park, 5042

  • Sunshine Hospital

    St Albans, 3021

  • Latrobe Regional Health

    Traralgon, 3844

Other trials in Australia

United States3 sites

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Henry Ford Health

    Detroit, Michigan, 48202

Other trials in United States

Hungary3 sites

  • Farkasgyepu Tudogyogyintezet

    Farkasgyepű, 8582

  • Bugat Pal Hospital

    Gyöngyös, 3200

  • Pecsi Tudomanyegyetem, Klinikai Kozpont

    Pécs, 7624

Other trials in Hungary

United Kingdom3 sites

  • The Royal Marsden in Sutton

    London, SM2 5PT

  • The Royal Marsden in Chelsea

    London, SW3 6JJ

  • The Christie Nhs Foundation Foundation Trust

    Manchester, M20 4BX

Other trials in United Kingdom

Austria2 sites

  • Universitatsklinikum St. Poelten

    Sankt Pölten, 3100

  • Medical University of Vienna - Akh

    Vienna, 1090

Other trials in Austria

Belgium2 sites

  • Jessa Ziekenhuis

    Hasselt, 3500

  • Uz Leuven Campus Gasthuisberg

    Leuven, 3500

Other trials in Belgium

Taiwan2 sites

  • National Taiwan University Hospital

    Taipei, 100225

  • Tri-Service General Hospital

    Taipei, 114202

Other trials in Taiwan

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

Romania1 site

  • Inst Oncologic "Prof Dr I Chiricuta" Cluj Napoca

    Cluj-Napoca

Other trials in Romania

About this study

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

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.

Being tested
S095018, S095024, S095029, S095018 Recommended Dose Expansion (RDE), S095024 RDE
Keywords
Non-small Cell Lung Carcinoma
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S095018Drug

    Via IV infusion on Day 1 of each 21-day cycle

  • S095024Drug

    Via IV infusion on Day 1 of each 21-day cycle

  • S095029Drug

    Via IV infusion on Day 1 of each 21-day cycle

  • S095018 Recommended Dose Expansion (RDE)Drug

    Via IV infusion on Day 1 of each 21-day cycle

  • S095024 RDEDrug

    Via IV infusion on Day 1 of each 21-day cycle

  • S095029 RDEDrug

    Via IV infusion on Day 1 of each 21-day cycle

  • CemiplimabDrug

    350 mg via IV infusion on Day 1 of each 21-day cycle

Study groups in NCT06162572
Study groupRoleWhat they receive
S095018 (anti-TIM3 antibody) in combination with cemiplimabExperimentalPart A: Combination-therapy safety lead-in
Receives: Drug: S095018; Drug: Cemiplimab
S095024 (anti-CD73 antibody) in combination with cemiplimabExperimentalPart A: Combination-therapy safety lead-in
Receives: Drug: S095024; Drug: Cemiplimab
S095029 (anti-NKG2A antibody) in combination with cemiplimabExperimentalPart A: Combination-therapy safety lead-in
Receives: Drug: S095029; Drug: Cemiplimab
S095018 (anti-TIM3 antibody) RDE in combination with cemiplimabExperimentalPart B: Randomized dose expansion
Receives: Drug: S095018 Recommended Dose Expansion (RDE); Drug: Cemiplimab
S095024 (anti-CD73 antibody) RDE in combination with cemiplimabExperimentalPart B: Randomized dose expansion
Receives: Drug: S095024 RDE; Drug: Cemiplimab
S095029 (anti-NKG2A antibody) RDE in combination with cemiplimabExperimentalPart B: Randomized dose expansion
Receives: Drug: S095029 RDE; Drug: Cemiplimab
Cemiplimab (control arm)Active comparatorPart B: Randomized dose expansion
Receives: Drug: Cemiplimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of dose-limiting toxicities (DLTs) during the first 2 cycles of combination treatment

    Part A

    Measured: Through the end of the Cycle 2 (each cycle is 21 days)

  2. Incidence and severity of adverse events (AEs)

    Part A

    Measured: From the signed informed consent form (ICF) to 30 days after the last dose

  3. Incidence and severity of serious adverse events (SAEs)

    Part A

    Measured: From the signed ICF to 120 days after the last dose

  4. Adverse Events (AEs) Leading to Dose Interruption, Modification, or Delays

    Part A

    Measured: From signed ICF through treatment discontinuation (up to 108 weeks of treatment)

  5. Adverse Events (AEs) Leading to Permanent Treatment Discontinuation

    Part A

    Measured: From signed ICF through treatment discontinuation (up to 108 weeks of treatment)

  6. Objective Response (OR)

    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.

    Measured: Until study termination (approximately 2 years)

Secondary outcomes (16)

  1. Objective Response (OR)

    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.

    Measured: Until study termination (approximately 3 years)

  2. Best Overall Response (BOR)

    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.

    Measured: Until study termination (approximately 3 years)

  3. Duration of Response (DoR)

    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.

    Measured: Until study termination (approximately 3 years)

  4. Disease Control (DC)

    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.

    Measured: Until study termination (approximately 3 years)

  5. 6-month Durable Response (6-month DR)

    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.

    Measured: Until study termination (approximately 3 years)

  6. Progression-Free Survival (PFS)

    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.

    Measured: Until study termination (approximately 3 years)

  7. Plasma or serum concentration of S095018

    Part A and B

    Measured: From first dose to 30 days after the last dose

  8. Plasma or serum concentration of S095024

    Part A and B

    Measured: From first dose to 30 days after the last dose

  9. Plasma or serum concentration of S095029

    Part A and B

    Measured: From first dose to 30 days after the last dose

  10. Incidence and titer of anti-drug antibodies (ADA) directed against S095018

    Part A and B

    Measured: From screening to 90 days after the last dose

  11. Incidence and titer of anti-drug antibodies (ADA) directed against S095024

    Part A and B

    Measured: From screening to 90 days after the last dose

  12. Incidence and titer of anti-drug antibodies (ADA) directed against S095029

    Part A and B

    Measured: From screening to 90 days after the last dose

  13. Incidence and severity of adverse events (AEs)

    Part B

    Measured: From signed ICF to 30 days after the last dose

  14. Incidence and severity of serious adverse events (SAEs)

    Part B

    Measured: From signed ICF to 120 days after the last dose

  15. Adverse Events (AEs) Leading to Dose Interruption, Modification, or Delays

    Part B

    Measured: From signed ICF through treatment discontinuation (up to 108 weeks of treatment)

  16. Adverse Events (AEs) Leading to Permanent Treatment Discontinuation

    Part B

    Measured: From signed ICF through treatment discontinuation (up to 108 weeks of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2023
  2. Study start7 Aug 2024
  3. Primary completionApr 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06162572
Sponsor's protocol ID
SPLFIO-174
Status last verified
Oct 2026
First submitted
29 Nov 2023
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing S095018, S095024 and S095029 in people with Non-small Cell Lung Cancer (NSCLC), run by Servier Bio-Innovation LLC at 52 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in Brazil, Italy, Spain, France, Australia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06162572.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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