OncoMatch/Clinical Trials/NCT05715229
Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy
Is NCT05715229 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for carcinoma, non-small-cell lung.
Treatment: Nivolumab · Ipilimumab · Carboplatin · Paclitaxel · Pemetrexed — This clinical trial plans to assess to what extent the on-treatment circulating tumor DNA (ctDNA) can predict the subset of patients with NSCLC who will respond to immunotherapy treatment only and which patients will need both immunotherapy and chemotherapy modalities for their treatment regimen.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression ≥1% by IHC using Dako 22C3 assay (≥1%)
positive PD-L1 expression ≥1% by IHC using Dako 22C3 assay
Required: EGFR oncogenic driver alteration
Patients with known EGFR...oncogenic driver alterations that have approved first-line targeted therapies are excluded from the study (All patients must have a tissue or blood-based testing to identify these driver alterations)
Required: ALK oncogenic driver alteration
Patients with known...ALK...oncogenic driver alterations that have approved first-line targeted therapies are excluded from the study (All patients must have a tissue or blood-based testing to identify these driver alterations)
Required: ROS1 oncogenic driver alteration
Patients with known...ROS1...oncogenic driver alterations that have approved first-line targeted therapies are excluded from the study (All patients must have a tissue or blood-based testing to identify these driver alterations)
Required: MET oncogenic driver alteration
Patients with known...MET...oncogenic driver alterations that have approved first-line targeted therapies are excluded from the study (All patients must have a tissue or blood-based testing to identify these driver alterations)
Required: RET oncogenic driver alteration
Patients with known...RET...oncogenic driver alterations that have approved first-line targeted therapies are excluded from the study (All patients must have a tissue or blood-based testing to identify these driver alterations)
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
Hemoglobin > 9 g/dL; Platelets > 100,000mm3 or 100 x 10^9/L; Absolute neutrophil count (ANC) > 1500 cells/mm3
Kidney function
Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 60ml/min calculated by Cockcroft and Gault's equation
Liver function
AST, ALT < 2.5 x ULN with no liver metastases or < 5x ULN with the presence of liver metastases; Total bilirubin < 1.5 x ULN if no liver metastases or < 3 x ULN in the presence of documented Gilbert's Syndrome or liver metastases
Adequate organ function; Hemoglobin > 9 g/dL; Platelets > 100,000mm3 or 100 x 10^9/L; AST, ALT < 2.5 x ULN with no liver metastases or < 5x ULN with the presence of liver metastases; Total bilirubin < 1.5 x ULN if no liver metastases or < 3 x ULN in the presence of documented Gilbert's Syndrome or liver metastases; Absolute neutrophil count (ANC) > 1500 cells/mm3; Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 60ml/min calculated by Cockcroft and Gault's equation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Lombardi Comprehensive Cancer Center, Georgetown University · Washington D.C., District of Columbia
- John Theurer Cancer Center, Hackensack Meridian Health · Hackensack, New Jersey
- Jersey Shore University Medical Center · Neptune City, New Jersey
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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