A Multicenter, Randomized, Controlled, Double Blind, Double Simulated, Phase III Clinical Study of Befotertinib vs Icotinib for Postoperative Adjuvant Treatment of IB-IIIB (T3N2M0) Stage Non Small Cell Lung Cancer With Positive EGFR Sensitive Mutations

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This multicenter, randomized, controlled, double-blind, double-simulated, Phase III study is designed to evaluate the efficacy and safety of Befotertinib compared with Icotinib as adjuvant treatment in EGFR-sensitive mutation-positive stage IB-IIIB (T3N2M0) non-small cell lung cancer after surgical resection.

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

• Willingness to sign informed consent prior to any study specific procedures, and ability to with scheduled visits, treatment plans, laboratory tests, and other study procedures.

• Male or female, aged at least 18 years.

• Histologically confirmed primary NSCLC, and mainly non-squamous cell carcinoma (including mixed type carcinoma mainly composed of adenocarcinoma components).

• Absence of brain metastasis.

• Complete resection of histologically confirmed Stage IB, II, IIIA or IIIB(T3N2M0) according to the TNM staging system for lung cancer (AJCC/UICC 8th edition), with negative margins.

• Confirmation by the central laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R).

• Patients who fully recover from surgery during randomization (any surgery must achieve complete postoperative wound healing) and should receive adjuvant treatment within 4-10 weeks after surgery.

• ECOG-PS score of 0 or 1 and did not deteriorate 2 weeks before the first administration of the investigational drug, with a minimum expected survival greater than 12 weeks.

• Female subjects with fertility need to have a negative serum pregnancy test during screening.

⁃ Female subjects who have possibility of becoming pregnant, as well as male subjects whose partners are women of childbearing age, must use a highly effective contraceptive method (such as oral contraceptives, intrauterine devices, abstinence or barrier contraception combined with spermicides) throughout the study and continue to use contraception for 3 months after the end of treatment.

Locations
Other Locations
China
Peking University International Hospital
RECRUITING
Beijing
Jiangsu Cancer Hospital
RECRUITING
Nanjing
Shanghai chest hospital
RECRUITING
Shanghai
Contact Information
Primary
Shun Lu, M.D.
shunlu@sjtu.edu.cn
+86 21 2220 0000
Time Frame
Start Date: 2023-03-28
Estimated Completion Date: 2029-11-30
Participants
Target number of participants: 570
Treatments
Experimental: Befotertinib + Icotinib placebo
Befotertinib (75 mg or 100 mg orally, once daily) and Icotinib placebo(125 mg orally, three times daily),in accordance with the randomization schedule
Active_comparator: Icotinib + Befotertinib placebo
Icotinib (125 mg orally, three times daily) and Befotertinib placebo (75 mg or 100 mg orally, once daily),in accordance with the randomization schedule
Sponsors
Leads: Betta Pharmaceuticals Co., Ltd.

This content was sourced from clinicaltrials.gov

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