The Efficacy and Safety of Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With EGFR Classical Mutations, a Prospective, Single-arm, Multicenter Clinical Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

To evaluate the efficacy, safety, recurrence site, recurrence pattern and resistance mechanism of 160mg furmonertinib as first-line therapy in advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR classical mutations(19Del or L858R).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 18 years old, Male or Female

• Histologically or cytologically confirmed locally advanced or metastatic lung adenocarcinoma not amenable to curative surgery or radiotherapy;

• Patients have been confirmed by local laboratory to have one of the following EGFR mutations: 19Del or L858R (single or compound)

• Patients had locally advanced NSCLC or metastatic NSCLC without any systemic antitumor therapy

• Having at least one measurable lesion (in accordance with RECIST1.1). Note: measurable lesion can neither be subject to local therapy as radiotherapy nor used for biopsy in screening period; if there is only one measurable lesion, this lesion will be permitted to be biopsied. However, the baseline radiological examination can be performed for this lesion at least 14 days after biopsy

• Adequate organ function as shown in the laboratory test, including: (1) ANC \>= 1.5 x 10\^9/L; PLT \>= 100 x 10\^9/L; HGB \>= 90 g/L; (2) TBIL \<= 1.5 times ULN, AST and ALT \<= 2.5 times ULN (with liver metastasis, TBIL \<= 3 times ULN, AST and ALT \<= 5 times ULN); (3) CrCL \>= 50 mL/min (according to Cockcroft-Gault formula);

• ECOG PS 0-1, and there was no obvious disease deterioration within 2 weeks prior to screening

• Life expectancy \> 12 weeks after the first dose of investigational product

• Female of childbearing age are not pregnant and have no pregnancy plan. Female subjects at childbearing age and male subjects agree to take effective contraceptive measures during the study and within 6 months after drug discontinuation

• Being able to understand and voluntarily participate in the study, and sign the informed consent form.

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Time Frame
Start Date: 2024-07-15
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 144
Treatments
Experimental: Furmonertinib
Furmonertinib 160mg, once daily, orally
Sponsors
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov