Recruiting PHASE2 NSCLC (Non-small Cell Lung Cancer)

New treatment option for NSCLC (Non-small Cell Lung Cancer)

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

ClinicalTrials.gov ID: NCT06863506

What this study is testing

What is befotertinib?

befotertinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for nsclc (non-small cell lung cancer).

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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).
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Age ≥18 years, ECOG performance status 0-2
  • Histologically confirmed locally advanced/metastatic NSCLC
  • Documented EGFR mutations: Cohort 1 (G719X/L861Q/S768I) or Cohort 2 (exon 20 insertion)
  • No prior EGFR-TKI therapy
  • Progression or intolerance to ≥1 line of platinum-based chemotherapy -≥1 measurable lesion per RECIST 1.1

You likely can't join if

  • Previous EGFR-TKI treatment
  • Active CNS metastases (asymptomatic patients with stable lesions allowed)
  • Severe cardiovascular disease (e.g., QTc ≥450 ms, myocardial infarction within 6 months)
  • Active HBV/HCV/HIV infection
  • Pregnancy or lactation

The study team makes the final eligibility decision.

Where it's taking place

  • Hangzhou, Zhejiang, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.