OncoMatch/Clinical Trials/NCT06269211

Neoadjuvant Toripalimab for Clinically Stage II-IIIB Resectable Non-small Cell Lung Cancer with EGFR Mutation and PD-L1 Positive Expression

Is NCT06269211 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Toripalimab for carcinoma, non-small-cell lung.

Phase 2RecruitingRuijin HospitalNCT06269211Data as of May 2026

Treatment: Toripalimab — The study is a prospective, open label, multicenter, single arm Phase II clinical trial, aiming to explore the use of neoadjuvant Toripalimab for clinically stage II-IIIB NSCLC patients with EGFR mutations and PD-L1 positive expression, providing a novel perspective for further improving the prognosis of NSCLC patients. This study will provide valuable information for further clinical trials of neoadjuvant Toripalimab and other immune checkpoint inhibitors in NSCLC patients with EGFR mutations and PD-L1 positive expression.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR sensitive mutation

tumor harbors EGFR mutations either sensitive mutations, uncommon mutations or complex mutations

Required: EGFR uncommon mutation

tumor harbors EGFR mutations either sensitive mutations, uncommon mutations or complex mutations

Required: EGFR complex mutation

tumor harbors EGFR mutations either sensitive mutations, uncommon mutations or complex mutations

Required: PD-L1 (CD274) tumor proportion score (TPS) ≥ 1% (TPS ≥ 1%)

PD-L1 tumor proportion score (TPS) ≥ 1% determined by IHC at the central laboratory

Excluded: ALK fusion

Molecular testing confirmed ALK translocation

Disease stage

Required: Stage II, IIIA, IIIB

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: systemic cancer therapy

Treatment with prior systemic cancer therapy for the current lung cancer at any time (chemotherapy, radiotherapy, target therapy, ablation, and any other local or systemic therapy)

Lab requirements

Blood counts

Adequate blood and organ function

Kidney function

Adequate blood and organ function

Liver function

Adequate blood and organ function

Adequate blood and organ function

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

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