Status:
NOT_YET_RECRUITING
T-Cell Repertoire Sequencing: Assessing Pembrolizumab Efficacy in Advanced Non-small Lung Cancer
Lead Sponsor:
Ari Raphael
Collaborating Sponsors:
Bar-Ilan University, Israel
Merck Sharp & Dohme LLC
Conditions:
Non-small Cell Lung Cancer Metastatic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
Subjects will receive pembrolizumab 200 mg combined with pemetrexed and platinum (investigator's choice of cisplatin or carboplatin), as indicated below: Pembrolizumab 200 mg + pemetrexed 500 mg/m2 (...
Eligibility Criteria
Inclusion
- 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.
- Adequate organ function.
Exclusion
- 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.
- Received prior radiotherapy within 2 weeks of start of study intervention.
- Major surgery within 14 days.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated or asymptomatic brain metastases may participate provided they are radiologically stable.
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06045767
Start Date
June 1 2024
End Date
January 1 2029
Last Update
June 3 2024
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