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Life sciences · Phase 2 Trial
ClinicalTrials.gov · November 4, 2026
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Phase 2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07709585). This is a study registration, not published results. Lead sponsor: Guangzhou University of Traditional Chinese Medicine. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 124 participants (ESTIMATED). Conditions: Advanced Non-small Cell Lung Cancer (NSCLC), EGFR Exon 19 Deletion Mutation, EGFR Exon 21 Mutation, EGFR Exon 21 L858R Mutation. Interventions: DRUG: Befotinib; DRUG: Pemetrexed + Cisplatin /Carboplatin. Primary outcome measures: Progression-Free Survival (PFS) , Up to 48 months after the last participant enrollment,including at least 24 months of follow-up after the last participant is enrolled.. Brief summary: This is a multicenter, phase II exploratory clinical trial in untreated patients with EGFR-mutant non-small cell lung cancer (stages IIIB-IV) .All participants will receive oral befotertinib monotherapy for 3 weeks first, then serial minimal residual disease (MRD/MRD) testing is performed to adjust subsequent treatment. Patients with positive MRD will receive 4 cycles of pemetrexed plus platinum chemotherapy; patients with negative MRD will continue single-agent befotertinib. After induction, maintenance therapy will be given according to follow-up MRD results. The primary goal is to evaluate progression-free survival guided by dynamic MRD monitoring, and secondary endpoints include objective response rate, disease control rate, safety and MRD clearance rate.