RecruitingPhase 2NCT06863506

Phase II Clinical Study of Befotertinib in EGFR Non-classical Mutant NSCLC

Prospective, Multi-cohort, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Befotertinib in EGFR-positive Non-classical Mutant Non-small Cell Lung Cancer Patients

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

78 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

NSCLC (Non-small Cell Lung Cancer)

Summary

This is a prospective, multi-cohort, single-arm Phase II clinical trial evaluating the efficacy and safety of befotertinib, a third-generation EGFR tyrosine kinase inhibitor (TKI), in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR non-classical mutations. The study comprises two independent cohorts: Cohort 1: Patients with EGFR uncommon mutations (G719X, L861Q, or S768I). Cohort 2: Patients with EGFR exon 20 insertion mutation Primary endpoint: Objective response rate (ORR) assessed by RECIST 1.1. Secondary endpoints: Disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety profile (CTCAE v4.03).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a targeted drug called befotertinib in people with advanced non-small cell lung cancer (NSCLC) whose tumors have specific uncommon EGFR gene mutations — not the most common type — and who have already tried chemotherapy. **You may be eligible if...** - You are 18 or older and in reasonably good health (ECOG 0–2) - You have locally advanced or metastatic NSCLC confirmed by biopsy - Your tumor has one of these specific EGFR mutations: G719X, L861Q, S768I (Cohort 1), or an exon 20 insertion mutation (Cohort 2) - You have not previously received an EGFR-targeted therapy (EGFR-TKI) - You have progressed on or could not tolerate at least one platinum-based chemotherapy regimen **You may NOT be eligible if...** - You have had prior EGFR-targeted therapy - You have active brain metastases (though stable lesions may be allowed) - You have severe heart problems or active viral infections (HIV, HBV, HCV) - 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

Befotertinib will be administered orally at an initial dose of 75 mg once daily for 21 days, with escalation to 100 mg if tolerated. Treatment continues until disease progression, unacceptable toxicity, or withdrawal.