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OncoMatch/Clinical Trials/NCT06041776

Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations

Is NCT06041776 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies non-drug interventions for non-small cell lung cancer.

Phase 3RecruitingBetta Pharmaceuticals Co., Ltd.NCT06041776Data as of May 2026

This multicenter, randomized, controlled, double-blind, double-simulated, Phase III study is designed to evaluate the efficacy and safety of Befotertinib compared with Icotinib as adjuvant treatment in EGFR-sensitive mutation-positive stage IB-IIIB (T3N2M0) non-small cell lung cancer after surgical resection.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR exon 19 deletion

Required: EGFR l858r

Disease stage

Required: Stage IB, II, IIIA, IIIB(T3N2M0) (AJCC/UICC 8th edition)

Complete resection of histologically confirmed Stage IB, II, IIIA or IIIB(T3N2M0) according to the TNM staging system for lung cancer (AJCC/UICC 8th edition), with negative margins

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: systemic anti-tumor therapy

Received systematic anti-tumor therapy, including chemotherapy, radiotherapy or targeted therapy (including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitors), immunotherapy, investigational therapy, etc., before being enrolled in this study

Lab requirements

Cardiac function

QTcF interval >450 ms (men) or >470 ms (women), symptomatic bradycardia (<45 beats /min), or other significant ECG abnormalities as determined by the investigator (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval >250 msec). Echocardiography showed LVEF <50%. Hypertension was clinically uncontrollable (e.g., blood pressure >160/100 mmHg; Except that isolated elevated readings that were determined by the investigators to be clinically insignificant or controllable hypertension.)

Clinically significant cardiovascular diseases, including: QTcF interval >450 ms (men) or >470 ms (women), symptomatic bradycardia (<45 beats /min), or other significant ECG abnormalities as determined by the investigator (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval >250 msec). Echocardiography showed LVEF <50%. Hypertension was clinically uncontrollable (e.g., blood pressure >160/100 mmHg; Except that isolated elevated readings that were determined by the investigators to be clinically insignificant or controllable hypertension.)

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

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