BridgeMD
A clinical study of pembrolizumab and other treatments for non-small cell lung cancer (MK-3475-01G)
EU CTIS ID: 2024-515772-12-00
What this study is testing
1. To evaluate ORR per RECIST 1.1 as assessed by BICR 2. To evaluate the safety and tolerability of investigational treatment combinations based on proportion of AEs
- Therapeutic exploratory (Phase II)
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 or cytologically confirmed diagnosis of Stage IV squamous or non-squamous non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) Staging Manual Version 8
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 7 days before randomization
- Has archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on ART
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to treatment randomization
You likely can't join if
- Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
- Has uncontrolled angina pectoris within 6 months
- Has cardiac arrhythmia requiring ongoing antiarrhythmic treatment
- Has history of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes
- Has bradycardia of less than 50 beats per minute (bpm) unless the participant has a pacemaker
- Has history of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers, and have no history of fainting or clinically relevant arrhythmia with pacemakers
See the full eligibility criteria
Who can join
- Histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) Staging Manual Version 8
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 7 days before randomization
- Has archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on ART
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to treatment randomization
What rules you out
- Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
- Has uncontrolled angina pectoris within 6 months
- Has cardiac arrhythmia requiring ongoing antiarrhythmic treatment
- Has history of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes
- Has bradycardia of less than 50 beats per minute (bpm) unless the participant has a pacemaker
- Has history of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers, and have no history of fainting or clinically relevant arrhythmia with pacemakers
- Has coronary/peripheral artery bypass graft within 6 months
- Has complete left bundle branch block
- Has inadequate washout period from prior concomitant therapy as specified in protocol before randomization
- Has received prior treatment with a topoisomerase I inhibitor or an anti-HER3 antibody and/or ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor
- Has received prior systemic anticancer therapy for their metastatic NSCLC
- Participants with squamous histology are excluded if there is a known tumor-activating epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) or c ros oncogene 1 (ROS1) gene rearrangement
- Has received prior therapy with an anti- programmed cell death 1 protein (anti-PD-1), anti- programmed cell death ligand 1 protein (anti-PD-L1), or anti- programmed cell death ligand 2 protein (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor
- Has received prior radiotherapy within 2 weeks of randomization, has radiation related toxicity requiring corticosteroids, or has had radiation pneumonitis
- Has Received radiation therapy to the lung that is >30 gray within 6 months of start of study intervention
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has severe hypersensitivity to any of the study interventions and/or any of their excipients
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has active infection requiring systemic therapy
- Is HIV-infected with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
- Has concurrent active Hepatitis B and Hepatitis C virus infection
- Have not adequately recovered from major surgery or have ongoing surgical complications
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement
- Has evidence of any leptomeningeal disease
- Has known history of, or active, neurologic paraneoplastic syndrome
- Has clinically significant corneal disease
- Has myocardial infarction within 6 months
- Has New York Heart Association (NYHA) Classes 3 or 4 congestive heart failure
The study team makes the final eligibility decision.
Where it's taking place
- Ukraine
- Chile
- Israel
- Korea, Republic of
- Turkey
- United States
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 Ukraine; Chile; Israel; Korea, Republic of; Turkey; United States. 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.