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Pembrolizumab for Advanced NSCLC and PS 2-3

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Start date: May 26, 2023 to Dec 5, 2023
    • Study completion date: May 2028 to May 2027
    v7
  2. Notable Primary completion date: May 2026 to May 2027
    • Study completion date: Oct 2026 to May 2028
    v6
  3. Notable Primary completion date: Mar 2025 to May 2026
    • Study completion date: Mar 2025 to Oct 2026
    • Start date: Jun 1, 2023 to May 26, 2023
    v5
  4. Minor Start date changed from estimate of Mar 2023 to Jun 1, 2023v4
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 2023 to Mar 2023
    • Site details revised
    v3
  6. Notable Start date: Nov 2022 to Feb 2023v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This single center open-label trial will enroll a single cohort of patients with advanced non-small cell lung cancer (NSCLC) who are ineligible for treatment with curative intent due to 1) disease stage IV, or 2) inability to tolerate intensive surgery or chemo-radiation. Patients will be eligible for the trial if ISMMS reviewed samples from tumor biopsy have a PDL-1 TPS ≥ 1% and have ECOG performance status rated 2 or 3. All patients will receive anti PD-1 therapy with pembrolizumab 200mg IV every 3 weeks, during which patients will also undergo serial QOL assessments. This trial will follow a phase II single arm, open label design. The study will enroll 45 patients evaluable for the primary endpoint of which will be change in QOL as measured by the EORTC's QLQ-C30 between Day 1 and Day 84 +/- 7 days. Secondary outcomes including evaluation for development of confounding mental health conditions will be evaluated via serial HADS assessments. Concomitant radiographic assessment with PET/CT, regardless of the doses of pembrolizumab received, will allow for evaluation of secondary efficacy outcomes, including disease response by RECIST 1.1 criteria.
Trial Details
NCT Number NCT05589818
Lead Sponsor Icahn School of Medicine at Mount Sinai
Conditions
(from sponsor)
Non-Small Cell Lung Cancer (NSCLC)
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov