OncoMatch/Clinical Trials/NCT05493566
Low-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer
Is NCT05493566 recruiting? Yes, currently enrolling (Jun 2026). This Early Phase 1 trial studies multiple treatments including Aldesleukin and Pembrolizumab for lung non-small cell carcinoma.
Treatment: Aldesleukin · Pembrolizumab — This early phase 1 trial will investigate the combination of low-dose interleukin-2 (IL-2) and pembrolizumab in patients with previously untreated stage IV non-small cell lung cancer (NSCLC). Preclinical data demonstrate reinvigoration of exhausted T cells into an effector-like phenotype with improved anti-tumor activity in response to this combination. This study will evaluate T cell function as well as clinical outcomes associated with this combination therapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression ≥1% (≥1%)
Patients must have tumor PD-L1 expression of ≥1% (by 22c3 PD-L1 companion testing); patients whose PD-L1 status could not be determined are also eligible. Patients with known PD-L1 of 0% will be excluded.
Excluded: ALK any targetable driver mutation
Any targetable driver mutation (e.g. ALK, EGFR exon 19 del, etc).
Excluded: EGFR exon 19 deletion
Any targetable driver mutation (e.g. ALK, EGFR exon 19 del, etc).
Disease stage
Required: Stage IV, IVA, IVB (AJCC v8)
Metastatic disease required
Stage IV non-small cell lung cancer (NSCLC), based on the 8th edition of the American Joint Committee on Cancer (AJCC) NSCLC Staging System.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Any prior chemotherapy or immunotherapy for advanced lung cancer.
Cannot have received: immunotherapy
Any prior chemotherapy or immunotherapy for advanced lung cancer.
Cannot have received: anti-PD-1 therapy
Prior treatment with anti-PD-1 or anti-PD-L1 therapies or pathway-targeting agents.
Cannot have received: anti-PD-L1 therapy
Prior treatment with anti-PD-1 or anti-PD-L1 therapies or pathway-targeting agents.
Lab requirements
Blood counts
ANC ≥ 1,500/mcL; Platelet count ≥ 100,000/mcL; Hemoglobin ≥ 9.0 g/dL (patients may be transfused to meet this)
Kidney function
Creatinine Clearance > 60 mL/min
Liver function
AST/ALT ≤ 2.5 x ULN; serum bilirubin ≤ 1.5 x ULN
Patients must have adequate organ and marrow function, including: Absolute neutrophil count (ANC) ≥ 1,500/mcL; Platelet count ≥ 100,000/mcL; Hemoglobin ≥ 9.0 g/dL (patients may be transfused to meet this); AST/ALT ≤ 2.5 x ULN; Serum bilirubin ≤ 1.5 x ULN; Creatinine Clearance > 60 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Emory University/Winship Cancer Institute · Atlanta, Georgia
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05493566 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.
Does this trial require CD274?
Yes, CD274 expression ≥1% is a required biomarker for enrollment.
Are patients with ALK alterations eligible?
No. ALK any targetable driver mutation is an exclusion criterion.
Are patients with EGFR alterations eligible?
No. EGFR exon 19 deletion is an exclusion criterion.
What disease stage is eligible?
Stage IV or IVA or IVB is required (metastatic disease required).
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 qualify