RECRUITING

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

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Conditions

Non-small Cell Lung Cancer (NSCLC)Non-small Cell Lung Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-08-07
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06162572

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patient aged ≥ 18 years
  2. * Written informed consent
  3. * Histologically (squamous or non-squamous) or cytologically documented locally advanced NSCLC not eligible for surgical resection and/or definitive chemoradiation, or metastatic NSCLC
  4. * No prior systemic treatment for locally advanced or metastatic NSCLC
  5. * High tumor cell PD-L1 expression \[Tumor Proportion Score (TPS) ≥50%\] based on documented status as determined by an approved test
  6. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  7. * Measurable disease as determined by RECIST v1.1
  1. * Tumors harboring driver mutations/genetic aberrations for which targeted therapies are approved as frontline treatment (e.g. EGFR mutation, ALK fusion oncogene, ROS1 aberrations)
  2. * Prior immune checkpoint inhibitor therapy
  3. * Active brain metastases
  4. * Participants with active and uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  5. * 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
  6. * Active, known or suspected autoimmune disease or immune deficiency
  7. * History of hypersensitivity reactions to any ingredient of the investigational medicinal product (IMP) and other monoclonal antibody (mAbs) and/or their excipients
  8. * History of interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis or active pneumonitis ≥ grade 2
  9. * History of inflammatory bowel disease or colitis ≥ grade 2
  10. * Systemic chronic steroid therapy (\>10mg/d prednisone or equivalent)
  11. * Active infection, including infection requiring systemic antibiotic therapy
  12. * Pregnant or breast-feeding (lactating) women
  13. * Participants with a history of allogeneic organ transplantation (e.g., stem cell or solid organ transplant)
  14. * Any medical condition that would in the investigator's judgement prevent the participant's participation in the clinical study

Contacts and Locations

Study Contact

Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
CONTACT
+33 1 55 72 60 00
scientificinformation@servier.com

Study Locations (Sites)

Loma Linda University
Loma Linda, California, 92354
United States
University of Kansas Medical Center
Lawrence, Kansas, 66160
United States
Henry Ford Health
Detroit, Michigan, 48202
United States
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, 89119
United States
Gabrail Cancer Center
Canton, Ohio, 44718
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
Virginia Cancer Specialists, P.C.
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Servier Bio-Innovation LLC

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 Registration Dates

Study Start Date2024-08-07
Study Completion Date2027-07

Study Record Updates

Study Start Date2024-08-07
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • Non-small Cell Lung Carcinoma

Additional Relevant MeSH Terms

  • Non-small Cell Lung Cancer (NSCLC)