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OncoMatch/Clinical Trials/NCT04585477

Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)

Is NCT04585477 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including AVENIO ctDNA Surveillance Kit and Durvalumab for non-small cell lung cancer.

Phase 2RecruitingStanford UniversityNCT04585477Data as of May 2026

Treatment: AVENIO ctDNA Surveillance Kit · Durvalumab · Durvalumab (Imfinzi) alone or in combination with platinum-based chemotherapyIn this study circulating tumor DNA (ctDNA) blood testing is used to detect the residual blood cancer. If residual cancer using this blood test is detected there may be at higher risk of having the cancer return. The study is going to test whether or not the number of circulating cancer cells detected in the blood can be reduced by administration durvalumab after the standard treatment if you are tested positive for the residual cancer.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Excluded: EGFR exon 19 deletion

Adenocarcinoma patients must NOT be positive for EGFR Exon 19 deletion or L858R mutation

Excluded: EGFR L858R

Adenocarcinoma patients must NOT be positive for EGFR Exon 19 deletion or L858R mutation

Excluded: ALK rearrangement

Adenocarcinoma patients must NOT be positive for ... ALK or ROS1 rearrangement

Excluded: ROS1 rearrangement

Adenocarcinoma patients must NOT be positive for ... ALK or ROS1 rearrangement

Disease stage

Required: Stage IA2, IB, IIA, IIB, IIIA, IIIB, IIIC (AJCC 8th edition)

Excluded: Stage IA1

AJCC 8th edition clinical or pathological stage IA2 to IIIC or locoregionally recurrent disease. Stage IA1 tumors are excluded unless recurrent with radiographic solid component -or- pathologic invasive component of > 10 mm.

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: surgery — curative intent

Received curative intent therapy with surgery and/or radiation

Must have received: radiation therapy — curative intent

Received curative intent therapy with surgery and/or radiation

Cannot have received: immunotherapy (PD-1, PD-L1, or CTLA-4 antibodies)

Exception: apart from this study

Not received immunotherapy (PD-1, PD-L1, or CTLA-4 antibodies) or be intended to receive immunotherapy, apart from this study.

Cannot have received: systemic anti-cancer investigational product

Not received another systemic anti-cancer investigational product during the 4 weeks prior to enrollment.

Lab requirements

Blood counts

Absolute neutrophil count > 1.0 x 10^9/L; Platelets > 75 x 10^9/L; Hemoglobin ≥ 9.0 g/dL

Kidney function

Creatinine ≤ 1.5 x ULN; or measured creatinine clearance >40 mL/min; or calculated creatinine clearance >40 mL/min by Cockcroft-Gault formula

Liver function

Serum bilirubin ≤ 1.5 x ULN (except Gilbert's syndrome); AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN

Acceptable laboratory parameters: Absolute neutrophil count > 1.0 x 10^9/L; Platelets > 75 x 10^9/L; Hemoglobin ≥ 9.0 g/dL; Creatinine ≤ 1.5 x ULN; or Measured creatinine clearance (CL) >40 mL/min; or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula; Serum bilirubin ≤ 1.5 x ULN (except Gilbert's syndrome); AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal (ULN)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Stanford University · Stanford, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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