OncoMatch/Clinical Trials/NCT04253964
Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy
Is NCT04253964 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for nonsmall cell lung cancer.
Treatment: Pembrolizumab · Carboplatin · Paclitaxel · Nab paclitaxel · Pemetrexed — This pilot study is configured as a non-inferiority comparison of Performance Status 2 patients with Performance Status 0-1 patients, with the goal of demonstrating non-inferiority in terms of efficacy (progression-free survival, overall survival) and safety (rates of adverse events, quality of life) when treating Performance Status 2 patients with the same first-line immunotherapy-based regimen as Performance Status 0-1 patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Excluded: EGFR activating mutation
a targetable mutation in epidermal growth factor receptor (EGFR)
Excluded: ALK rearrangement
gene rearrangement of anaplastic lymphoma kinase (ALK)
Excluded: ROS1 rearrangement
gene rearrangement of c-ros oncogene 1 (ROS1)
Excluded: BRAF mutation
mutation in B isoform of rapidly accelerated fibrosarcoma (B-Raf)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Exception: prior therapy with curative intent for early-stage disease allowed
No prior systemic treatment with either chemotherapy or immunotherapy for non-curative intent. Patients may have previously received cancer treatment with curative intent for prior early-stage disease.
Cannot have received: immunotherapy
Exception: prior therapy with curative intent for early-stage disease allowed
No prior systemic treatment with either chemotherapy or immunotherapy for non-curative intent. Patients may have previously received cancer treatment with curative intent for prior early-stage disease.
Lab requirements
Blood counts
absolute neutrophil count ≥1,000/mcl; platelets ≥100,000/mcl
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Wake Forest Baptist Comprehensive Cancer Center · Winston-Salem, North Carolina
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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