OncoMatch/Clinical Trials/NCT05589818
Pembrolizumab for Advanced NSCLC and PS 2-3
Is NCT05589818 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pembrolizumab for non-small cell lung cancer (nsclc).
Treatment: Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK molecular alteration
Patients may not have a molecular alteration in ALK, ROS1, EGFR, BRAF, NTRK, RET, MET, or any other gene for which first-line FDA approved targeted therapy exists.
Required: ROS1 molecular alteration
Patients may not have a molecular alteration in ALK, ROS1, EGFR, BRAF, NTRK, RET, MET, or any other gene for which first-line FDA approved targeted therapy exists.
Required: EGFR molecular alteration
Patients may not have a molecular alteration in ALK, ROS1, EGFR, BRAF, NTRK, RET, MET, or any other gene for which first-line FDA approved targeted therapy exists.
Required: BRAF molecular alteration
Patients may not have a molecular alteration in ALK, ROS1, EGFR, BRAF, NTRK, RET, MET, or any other gene for which first-line FDA approved targeted therapy exists.
Required: NTRK1 molecular alteration
Patients may not have a molecular alteration in ... NTRK ... or any other gene for which first-line FDA approved targeted therapy exists.
Required: NTRK2 molecular alteration
Patients may not have a molecular alteration in ... NTRK ... or any other gene for which first-line FDA approved targeted therapy exists.
Required: NTRK3 molecular alteration
Patients may not have a molecular alteration in ... NTRK ... or any other gene for which first-line FDA approved targeted therapy exists.
Required: RET molecular alteration
Patients may not have a molecular alteration in ALK, ROS1, EGFR, BRAF, NTRK, RET, MET, or any other gene for which first-line FDA approved targeted therapy exists.
Required: MET molecular alteration
Patients may not have a molecular alteration in ALK, ROS1, EGFR, BRAF, NTRK, RET, MET, or any other gene for which first-line FDA approved targeted therapy exists.
Performance status
ECOG 2–3(Limited self-care)
Prior therapy
Cannot have received: PD-1 inhibitor
Patients must not have received any PD-1 or PD-L1 inhibitor
Cannot have received: PD-L1 inhibitor
Patients must not have received any PD-1 or PD-L1 inhibitor
Lab requirements
Blood counts
Leukocytes ≥ 3,000/mcL; Absolute neutrophil count ≥ 1,000/mcL; Platelets ≥ 100,000/mcl
Kidney function
GFR (Cockroft-Gault) ≥ 30 mL/min
Liver function
Total bilirubin ≤ 1.5 x ULN; AST (SGOT)/ALT (SPGT) ≤ 3 x ULN or ≤5 x ULN if liver metastases present
Adequate organ and marrow function as defined below: * Leukocytes ≥ 3,000/mcL * Absolute neutrophil count ≥ 1,000/mcL * Platelets ≥ 100,000/mcl * Total bilirubin ≤ 1.5 x ULN * AST (SGOT)/ALT (SPGT) ≤ 3 x ULN or ≤5 x ULN if liver metastases present * GFR (Cockroft-Gault) ≥ 30 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mount Sinai Hospital · New York, New York
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