Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With E… (NCT05466149) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With EGFR Exon 20 Insertion
China100 participantsStarted 2022-09-27
Plain-language summary
This is a Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Furmonertinib in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations.
The study plans to enroll approximately 100 patients from approximately 70 sites. Patients are locally advanced or metastatic NSCLC with EGFR exon 20 insertions who have progressed during or after platinum-based chemotherapy. Furmonertinib Mesilate will be treated 240 mg QD until disease progression or unacceptable toxicity.
Primary endpoint is ORR. Secondary endpoints include DOR, DCR, DepOR, PFS, OS, CNS ORR, CNS DOR, CNS PFS, safety and the PK profile of Furmonertinib Mesilate and its metabolites (AST5902).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ≥ 18 years at time of signing Informed Consent Form
* Histologically or cytologically documented, locally advanced or metastatic NSCLC not amenable to curative surgery or radiotherapy
* Documented validated results from local or central testing (as designated by the Sponsor) of blood or tumor tissue confirming the presence of an EGFR exon 20 insertion mutation
* Documented radiologic progression on or after prior platinum-based chemotherapy (with or without anti-PD1/PD-L1 agents) in the locally advanced or metastatic setting
* Documented radiologic disease progression during or after the last systemic anticancer therapy before the first dose of furmonertinib
* Measurable disease per RECIST v1.1
* ECOG performance status of 0 or 1
* Life expectancy of ≥ 12 weeks
* Patients with CNS metastases are eligible, provided they meet all of the following criteria: Measurable disease outside the CNS; No ongoing requirement for corticosteroids as therapy for CNS metastases, with corticosteroids discontinued for ≥ 2 weeks prior to enrollment; No ongoing symptoms attributed to CNS metastases; No active CNS metastases or spinal cord compression (i.e., progressing or requiring anticonvulsants or corticosteroids for symptomatic control); No evidence of interim CNS disease progression between the completion of CNS-directed therapy and the screening radiographic study; Time since whole brain radiation therapy (WBRT) is ≥ 21 days prior to first dose of study treatment,…
What they're measuring
1
ORR, Objective Response Rate
Timeframe: Approximately 7.5 months following the last patient enrolled