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Furmonertinib 160mg / Furmonertinib 240mg / Nsclc · Phase 1 Trial
ClinicalTrials.gov · August 14, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1b clinical trial registration for furmonertinib in NSCLC patients with EGFR exon 20 insertion mutations. Recruitment has been completed but no efficacy or safety results are reported in this registry record, and the primary outcome measure is objective response rate (ORR) assessed up to 12 months.
Phase 1, Interventional, Randomized, Single Group, Open label, Treatment purpose. NSCLC; age from 18 Years; to 75 Years. Intervention: treated subjects will receive Furmonertinib 160mg/day,; treated subjects will receive Furmonertinib 240mg/day,; treatment-naïve subjects will receive Furmonertinib 240mg/d…. Compared with: Two-arm comparison within pretreated cohort (160 mg vs 240 mg); treatment-naïve cohort received single dose (240 mg) with no comparator.. n = 90. 1 site: China.
This is a Phase 1b clinical trial registration for furmonertinib in NSCLC patients with EGFR exon 20 insertion mutations. Recruitment has been completed but no efficacy or safety results are reported in this registry record, and the primary outcome measure is objective response rate (ORR) assessed up to 12 months.
No results are reported in this registry record; outcomes, response rates, and safety data are not available.
Clinicians awaiting efficacy and safety data should monitor for publication of results from this completed Phase 1b study. This registry record alone does not provide sufficient evidence to guide treatment decisions.
Phase 1b registry record with recruitment completed but no results posted; describes planned efficacy and safety exploration in a small, dose-ranging study of a novel agent.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians awaiting efficacy and safety data should monitor for publication of results from this completed Phase 1b study. This registry record alone does not provide sufficient evidence to guide treatment decisions.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04858958). This is a study registration, not published results. Lead sponsor: Allist Pharmaceuticals, Inc.. Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 90 participants (ACTUAL). Conditions: NSCLC. Interventions: DRUG: Furmonertinib 160mg; DRUG: Furmonertinib 240mg. Primary outcome measures: ORR, objective response rate , up to 12 months. Brief summary: This is a phase Ⅰb multi-center clinical study. To explore the preliminary efficacy and safety of Furmonertinib Mesilate at different doses in locally advanced or metastatic NSCLC patients with EGFR exon 20 insertion mutation. The study plans to enroll 30 subjects, including 20 treated patients and 10 treatment-naïve patients. The subjects with disease progression after previous systematic anti-tumor therapy will be randomized to receive Furmonertinib Mesilate 160 mg/day (N=10) or 240 mg/day (N=10), respectively. The treatment-naïve patients do not need to be randomized and all will receive Furmonertinib Mesilate 240 mg/day (N=10) until disease progression, death or intolerability. The primary endpoint is ORR; the secondary study endpoints include DCR, DOR, DepOR, PFS, OS, CNS ORR, safety and the PK profile of Furmonertinib Mesilate and its metabolites (AST5902). In addition, the peripheral blood ctDNA will be collected and analyzed in this study
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.