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OncoMatch/Clinical Trials/NCT06426511

ctDNA-MRD Guided Consolidation Toripalimab in Stage IB-IIIA NSCLC

Is NCT06426511 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Toripalimab+Chemotherapy and Toripalimab+Chemotherapy followed by consolidation toripalimab for lung cancer, nonsmall cell.

Phase 2RecruitingSun Yat-sen UniversityNCT06426511Data as of May 2026

Treatment: Toripalimab+Chemotherapy · Toripalimab+Chemotherapy followed by consolidation toripalimabThis study aims to incorporate circulating tumor DNA (ctDNA)-minimal residual disease (MRD) to personalize the administration of consolidation toripalimab therapy in resected stage IB-IIIA non-small-cell lung cancer (NSCLC) after adjuvant therapy. Toripalimab is a humanized monoclonal antibody for human programmed cell death protein 1. Toripalimab was approved as a consolidation treatment after perioperative therapy in combination with chemotherapy for resectable stage III NSCLC.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: ALK wild-type

Required: EGFR wild-type

Disease stage

Required: Stage IB, II, IIIA

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic antitumor therapy

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥2.0 x 10^9/L, Platelet count ≥100 x 10^9/L, Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level)

Kidney function

Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min

Liver function

Total bilirubin ≤ 1.5 x upper limit of normal (ULN), AST, ALT ≤ 2.5 x ULN

Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 10^9/L, and Platelet count ≥100 x 10^9/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level); Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN; Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min

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

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