BridgeMD
A study to evaluate novel immunotherapy combinations in participants with advanced non-small cell lung cancer (NSCLC)
EU CTIS ID: 2023-508730-34-00
What this study is testing
Part A (combination therapy safety lead-in): To evaluate the safety and tolerability of each combination arm and to confirm the recommended dose for expansion (RDE) Part B (Randomized dose expansion): To evaluate the efficacy of each combination arm compared with the cemiplimab (control) arm
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- Adult participants (must be ≥18 years of age or according to local requirement)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Measurable disease as determintaed by RECIST v1.1
You likely can't join if
- Tumors harboring driver mutations/genetic aberrations for which targeted therapies are approved as frontline treatment (e.g., EGFR mutation, ALK fusion oncogene, ROS1 aberrations)
- 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
See the full eligibility criteria
- 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
- Adult participants (must be ≥18 years of age or according to local requirement)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Measurable disease as determintaed 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)
- 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)
- Clinical significant infection, as assessed by the investigators.
- 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
- Prior immune checkpoint inhibitor therapy.
- Active brain metastases
- Participants with active and uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Hong Kong
- United Kingdom
- Korea, Republic of
- Brazil
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Hong Kong; United Kingdom; Korea, Republic of; Brazil; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.