T-Cell Repertoire Sequencing: Assessing Pembrolizumab Efficacy in Advanced Non-small Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAri Raphael
About this trial
This is a single site, non-randomized trial for the assessment of intravenous (IV) pembrolizumab (also known as MK-3475) combined with pemetrexed/platinum-based chemotherapy in subjects with advanced or metastatic non-squamous non-small lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease and in whom directed therapy is not indicated. Approximately 30 subjects will be enrolled in this trial to examine the clonality and diversity dynamics matched with disease response evaluated by RECIST 1.1.
Eligibility criteria
Qualifiers
Participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Archival tumor tissue sample or newly obtained [core, incisional or excisional] biopsy of a tumor lesion not previously irradiated has been provided.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Disqualifiers
Pregnancy or breastfeeding
Aberration in a known targetable molecular driver.
Received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
Received prior systemic anti-cancer therapy for metastatic disease.
Trial design
Treatments tested in this trial
- Pembrolizumab 50 MG Injection [Keytruda]
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Ari Raphael
Lead sponsor
Tel Aviv Medical Center
Sponsor institution
Bar-Ilan University, Israel
Collaborator
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov