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New immunotherapy cocktails aim to shrink tough lung tumors

NCT ID NCT06162572

Disease control Sponsor: Servier Bio-Innovation LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times

Summary

This study tests three different immunotherapy drug combinations in people with advanced non-small cell lung cancer that has high PD-L1 levels and has not been treated before. The goal is to see if adding another immune-boosting drug to the standard anti-PD1 therapy can better control the cancer. About 102 adults will participate, and treatment lasts up to 108 weeks unless the disease gets worse.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

102 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer (NSCLC)

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Azienda Ospedaliera S. Maria Della Misericordia

    Perugia, 06132, Italy

  • Border Medical Oncology Research Unit

    Albury, 2640, Australia

  • Bugat Pal Hospital

    Gyöngyös, 3200, Hungary

  • CIONC

    Curitiba, 80810-050, Brazil

  • Centre Georges Francois Leclerc

    Dijon, 21079, France

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

    Saint-Herblain, 44805, France

  • Centro Di Riferimento Oncologico

    Aviano, 33081, Italy

  • Chu Grenoble Alpes

    Grenoble, 38043, France

  • Clinica Universitaria de Navarra (Madrid)

    Madrid, 28027, Spain

  • Clinica Universitaria de Navarra (Pamplona)

    Pamplona, 31008, Spain

  • Farkasgyepu Tudogyogyintezet

    Farkasgyepű, 8582, Hungary

  • Flinders Medical Centre

    Bedford Park, 5042, Australia

  • Gabrail Cancer Center

    Canton, Ohio, 44718, United States

  • Henry Ford Health

    Detroit, Michigan, 48202, United States

  • Hospital A C Camargo

    São Paulo, 01509-010, Brazil

  • Hospital Albert Einstein

    São Paulo, 05652-900, Brazil

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007, Spain

  • Hospital São Camilo

    São Paulo, 03102-002, Brazil

  • Hospital São Lucas Da Pucrs

    Porto Alegre, 90619-900, Brazil

  • Hospital Univ. Hm Sanchinarro Start Ciocc Early Phase

    Madrid, 28050, Spain

  • Hospital Universitario Virgen de La Victoria

    Málaga, 29010, Spain

  • Hospital Universitario Y Politecnico La Fe

    Valencia, 46026, Spain

  • Hospital de Amor - Barretos

    Barretos, 14784-400, Brazil

  • Inst Oncologic "Prof Dr I Chiricuta" Cluj Napoca

    Cluj-Napoca, Romania

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

    Meldola, 47014, Italy

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Institut Paoli Calmette

    Marseille, 13009, France

  • Instituto Médico Especializado Alexander Fleming

    Buenos Aires, Argentina

  • Irccs Fondazione Istituto Nazionale Dei Tumori

    Milan, 20133, Italy

  • Ist. Nazionale Tumori Irccs Fondazione G Pascale

    Naples, 80131, Italy

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

    Rozzano, 20089, Italy

  • Istituto Europeo Di Oncologia

    Milan, 20141, Italy

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144, Italy

  • Jessa Ziekenhuis

    Hasselt, 3500, Belgium

  • Latrobe Regional Health

    Traralgon, 3844, Australia

  • Liga Contra O Cancer - Natal

    Natal, 59035-055, Brazil

  • Medical University of Vienna - Akh

    Vienna, 1090, Austria

  • National Taiwan University Hospital

    Taipei, 100225, Taiwan

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • Oncoclinicas Rj

    Rio de Janeiro, 22250-905, Brazil

  • Oncoclinicas Sp

    São Paulo, 04538-132, Brazil

  • Ordensklinikum Linz Elisabethinen

    Linz, 4020, Austria

  • Pecsi Tudomanyegyetem, Klinikai Kozpont

    Pécs, 7624, Hungary

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Sanatorio Parque S.A.

    Santa Fe, Argentina

  • Santa Casa de Porto Alegre

    Porto Alegre, 90020-090, Brazil

  • Sunshine Hospital

    St Albans, 3021, Australia

  • Supera Oncologia

    Chapecó, 89812618, Brazil

  • The Christie Nhs Foundation Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • The Royal Marsden in Chelsea

    London, SW3 6JJ, United Kingdom

  • The Royal Marsden in Sutton

    London, SM2 5PT, United Kingdom

  • Tri-Service General Hospital

    Taipei, 114202, Taiwan

  • Universitatsklinikum St. Poelten

    Sankt Pölten, 3100, Austria

  • Uz Leuven Campus Gasthuisberg

    Leuven, 3500, Belgium

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

    Barcelona, 08035, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.