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

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.

Conditions

Non-small Cell Lung Cancer (NSCLC)

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Non-small Cell Lung Cancer (NSCLC)
Intervention / Treatment

-

Contacts and Locations

Loma Linda

Loma Linda University, Loma Linda, California, United States, 92354

Lawrence

University of Kansas Medical Center, Lawrence, Kansas, United States, 66160

Detroit

Henry Ford Health, Detroit, Michigan, United States, 48202

Las Vegas

Comprehensive Cancer Center of Nevada, Las Vegas, Nevada, United States, 89119

Canton

Gabrail Cancer Center, Canton, Ohio, United States, 44718

Columbus

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States, 43210

Fairfax

Virginia Cancer Specialists, P.C., Fairfax, Virginia, United States, 22031

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Servier Bio-Innovation LLC,

Study Record Dates

2027-07