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Neoadjuvant Furmonertinib and Cisplatin/Pemetrexed as in EGFR Mutated Stage IIA-IIIB Resectable NSCLC (FORESEE)

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Start date: Feb 24, 2022 to Jan 10, 2023
    • Interventions: Furmonertinib+cisplating/pemetrexed (Drug) to Furmonertinib+cisplating/pemetrexed (Drug)
    • Eligibility criteria expanded, about 23 words
  2. Enrollment closed, study ongoing
    • Study completion pushed from Sep 1, 2026 to Dec 1, 2029
    • Site details revised
    v3
  3. Primary completion date changed from estimate of Mar 1, 2023 to Sep 1, 2025v2 Show 4 more changesShow less
    • Study completion date: Mar 1, 2026 to Sep 1, 2026
    • Secondary endpoints: 6 to 7
    • Study title revised
    • Eligibility criteria shortened, about 2 words
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In this single-arm, phase II clinical trial, patients with resectable, EGFR-mutated, stage II-IIIB NSCLC received neoadjuvant therapy with furmonertinib (oral, 80 mg once daily, stopped 1 week preoperatively) in combination with platinum-based doublet chemotherapy every 3 weeks for a total of 3 cycles. Surgery was performed 4-6 weeks after chemotherapy. The primary endpoint was objective response rate (ORR). Secondary endpoints included the pathological complete response (pCR) rate, major pathological response (MPR) rate, TNM downstaging rate, R0 resection rate, EFS, overall survival (OS), drug safety and surgical complications.
Trial Details
NCT Number NCT05430802
Lead Sponsor Tang-Du Hospital
Conditions
(from sponsor)		 Non-small Cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov