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Sequential Chemotherapy With Befotertinib in Non-Small Cell Lung Cancer (NSCLC) Patients With Resistance to Third-Generation EGFR-TKI

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 2v3 Show 1 more changeShow less
    • Study sites: 1 to 2
  2. Interventions: Bevacizumab (Drug), Chemotherapy (Drug) to Befotertinib (Drug), Pemetrexed + Carboplatin (Drug) Eligibility criteria shortened, about 34 wordsv2 Show 1 more changeShow less
    • Eligibility criteria shortened, about 34 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Non-small cell lung cancer (NSCLC) accounts for over 85% of lung cancers. Approximately 30-40% of East Asian adenocarcinoma patients harbor EGFR mutations. Third-generation EGFR-TKIs achieve a median PFS of about 20 months as first-line therapy, but resistance eventually develops. Studies like MARIPOSA-2 confirm that amivantamab combined with chemotherapy ± lazertinib or immunotherapy regimens (ivucitinib/sintilimab + bevacizumab + chemotherapy) can extend median PFS post-resistance from approximately 4 months to 6-8 months. As a third-generation TKI, befitinib has demonstrated PFS of 16-22 months in both first-line and post-T790M mutation settings. This study aims to further evaluate the feasibility and safety of "pemetrexed + carboplatin followed by befotertinib" for patients resistant to third-generation TKIs.
Trial Details
NCT Number NCT07181499
Lead Sponsor Betta Pharmaceuticals Co., Ltd.
Conditions NSCLC, Adjuvant Drug Therapy, EGFR
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov