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ACTIVE NOT RECRUITING Phase 1

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

NCT06162572 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG S095018
  • DRUG S095024
  • DRUG S095029
  • DRUG S095018 Recommended Dose Expansion (RDE)
  • DRUG S095024 RDE

Study Locations (20)

Other

  • Instituto Médico Especializado Alexander Fleming — Buenos Aires
  • Sanatorio Parque S.A. — Santa Fe
  • Border Medical Oncology Research Unit — Albury
  • Flinders Medical Centre — Bedford Park
  • Sunshine Hospital — St Albans
  • Latrobe Regional Health — Traralgon
  • Ordensklinikum Linz Elisabethinen — Linz
  • Universitatsklinikum St. Poelten — Sankt Pölten
  • Medical University of Vienna - Akh — Vienna
  • Jessa Ziekenhuis — Hasselt
  • Uz Leuven Campus Gasthuisberg — Leuven
  • Hospital de Amor - Barretos — Barretos
  • Supera Oncologia — Chapecó
  • CIONC — Curitiba

Ohio

  • Gabrail Cancer Center — Canton
  • Ohio State University Comprehensive Cancer Center — Columbus

California

  • Loma Linda University — Loma Linda

Michigan

  • Henry Ford Health — Detroit

Nevada

  • Comprehensive Cancer Center of Nevada — Las Vegas

Virginia

  • Virginia Cancer Specialists, P.C. — Fairfax

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2024-08-07
Est. Completion 2027-07
Phase Phase 1

Sponsor

Servier Bio-Innovation

36 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06162572

The ClinicalTrials.gov registry entry for NCT06162572 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Servier Bio-Innovation, which has 36 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Non-small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 5 interventions — of which S095018 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06162572 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Other, Ohio, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06162572 about?

NCT06162572 is a clinical study titled "Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)". 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...

What is the current status of trial NCT06162572?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2024-08-07. Estimated completion is 2027-07.

What conditions does trial NCT06162572 study?

This clinical trial studies the following conditions: Non-small Cell Lung Cancer (NSCLC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06162572?

The interventions under investigation include: S095018 (DRUG), S095024 (DRUG), S095029 (DRUG), S095018 Recommended Dose Expansion (RDE) (DRUG), S095024 RDE (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06162572?

This trial is sponsored by Servier Bio-Innovation, which has 36 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06162572 being conducted?

This trial has 20 study locations across California, Michigan, Nevada, Ohio, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial