RecruitingPhase 3NCT06041776

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

A Multicenter, Randomized, Controlled, Double Blind, Double Simulated, Phase III Clinical Study of Befotertinib vs Icotinib for Postoperative Adjuvant Treatment of IB-IIIB (T3N2M0) Stage Non Small Cell Lung Cancer With Positive EGFR Sensitive Mutations

Sponsor

Betta Pharmaceuticals Co., Ltd.

Enrollment

570 participants

Start Date

Mar 28, 2023

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer Adjuvant Therapy EGFR Sensitive Mutation

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a targeted drug called befotertinib (an EGFR inhibitor) taken after surgery reduces the risk of lung cancer coming back in patients with early- to mid-stage non-small cell lung cancer that has a specific EGFR gene mutation. **You may be eligible if...** - You are 18 or older with confirmed non-squamous non-small cell lung cancer (stage IB, II, IIIA, or IIIB with T3N2M0) - Your tumor was completely surgically removed with clear margins - A laboratory test confirmed your tumor has a common EGFR mutation (exon 19 deletion or L858R) - You have not had brain metastases **You may NOT be eligible if...** - Your cancer was not completely removed by surgery - You have already received EGFR-targeted therapy or chemotherapy after surgery - You have significant heart, liver, or lung problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBefotertinib + Icotinib placebo

The initial dose of Befotertinib is 75 mg orally once daily (QD) for 21 days, and then increased to 100 mg orally QD in the absence of serious side effects , CTCAE grade ≥ 2 headache or thrombocytopenia during the 21 days. Befotertinib can be taken on an empty stomach or after meals, and the medication is used until the disease relapses or intolerable toxicity occurs, or the treatment lasts for 3 years (disease recurrence includes local recurrence and/or distant metastasis) Icotinib placebo 125 mg three times daily, on an empty stomach or in combination with food, use medication until the disease relapses or intolerable toxicity occurs or treatment lasts for 2 years (disease recurrence includes local recurrence and/or distant metastasis).

DRUGIcotinib + Befotertinib placebo

Icotinib 125 mg three times daily, on an empty stomach or in combination with food, use medication until the disease relapses or intolerable toxicity occurs or treatment lasts for 2 years (disease recurrence includes local recurrence and/or distant metastasis). The initial dose of Befotertinib placebo is 75 mg orally once daily (QD) for 21 days, and then increased to 100 mg orally QD in the absence of serious side effects , CTCAE grade ≥ 2 headache or thrombocytopenia during the 21 days. Befotertinib placebo can be taken on an empty stomach or after meals, and the medication is used until the disease relapses or intolerable toxicity occurs, or the treatment lasts for 3 years (disease recurrence includes local recurrence and/or distant metastasis.

Locations(3)

Peking University International Hospital

Beijing, China

Jiangsu Cancer Hospital

Nanjing, China

Shanghai chest hospital

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT06041776

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