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OncoMatch/Clinical Trials/NCT06426511

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

Is NCT06426511 recruiting? Yes, currently enrolling (Jun 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 Jun 2026Location: China

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

Treatments studied

Other

Toripalimab+ChemotherapyToripalimab+Chemotherapy followed by consolidation toripalimab

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)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT06426511 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 ALK?

Yes, ALK wild-type is a required biomarker for enrollment.

Does this trial require EGFR?

Yes, EGFR wild-type is a required biomarker for enrollment.

What disease stage is eligible?

Stage IB or II or IIIA is required.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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