Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Clinical summary
Summary
This study is evaluating a type of immunotherapy called cemiplimab in combination with other forms of immunotherapy in participants with previously untreated advanced or metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression.
The study is made up of two parts:
Part A aims to determine the recommended dose of each combination of immunotherapy through a combination-therapy safety lead-in phase.
Part B will assess the effectiveness of each combination of immunotherapy through a randomised dose expansion phase.
Participants will be randomally allocated into one of four groups:
- Experimental: S095018 (anti-TIM3 antibody) in combination with cemiplimab
- Experimental: S095024 (anti-CD73 antibody) in combination with cemiplimab
- Experimental: S095029 (anti-NKG2A antibody) in combination with cemiplimab
- Active Comparator: Cemiplimab (control arm)
All participants will recieve their treatment on Day 1 of a 21 day cycle via IV infusion.
Treatment will be administered for a maximum of 108 weeks, or until confirmed disease progression and/or until meeting other treatment discontinuation criteria.
Conditions
This trial is treating people with Advanced Non-small Cell Lung Cancer (NSCLC) who have not had prior systemic treatment for their advanced or metastatic disease
Eligibility
Inclusion
- 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
- 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
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Servier Bio-Innovation LLC
Scientific 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
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