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 (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
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 →Frequently asked questions
Is NCT04253964 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Are patients with EGFR alterations eligible?
No. EGFR activating mutation is an exclusion criterion.
Are patients with ALK alterations eligible?
No. ALK rearrangement is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages