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Testing new immunotherapy combinations for advanced lung cancer

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

Phase1; Phase2 Interventional Servier · NCT06162572

This study is testing a new combination of immunotherapy drugs to see if they can help adults with untreated advanced lung cancer feel better and live longer.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment176 (estimated)
Ages18 Years and up
SexAll
SponsorServier Industry-sponsored
Drugs / interventionsprednisone, cemiplimab
Locations73 sites (Loma Linda, California and 72 other locations)
Trial IDNCT06162572 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the anti-PD1 antibody cemiplimab combined with other antibodies (S095018, S095024, S095029) in adults with untreated advanced non-small cell lung cancer (NSCLC) that has high PD-L1 expression. It consists of two parts: a safety lead-in phase to determine the recommended dose for expansion and a randomized dose expansion phase to assess the efficacy of these combinations. Participants will receive treatment for up to 108 weeks or until disease progression occurs. The study aims to improve treatment options for patients with this challenging cancer.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with untreated advanced or metastatic NSCLC and high PD-L1 expression.

Not a fit: Patients with specific driver mutations or those who have previously received immune checkpoint inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced non-small cell lung cancer.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy combinations, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)
* Active infection, including infection requiring systemic antibiotic therapy
* 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

Where this trial is running

Loma Linda, California and 72 other locations

+23 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-small Cell Lung CancerNon-small Cell Lung Carcinoma
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.