Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer: a Single-center, Randomized Controlled Trial

Peng Zhang1 site in 1 country60 target enrollmentNovember 7, 2024

ConditionsEGFR Non-Small Cell Lung Cancer Locally Advanced Non-Small Cell Lung Cancer Pemetrexed Carboplatin Bevacizumab Antineoplastic Agents Tyrosine Kinase Inhibitor

InterventionsBefotertinib combined Bevacizumab Befotertinib combined platinum-based double chemotherapy

DrugsBefotertinib combined Bevacizumab Befotertinib combined platinum-based double chemotherapy

Overview

Phase: Phase 2
Intervention: Befotertinib combined Bevacizumab
Conditions: EGFR
Sponsor: Peng Zhang
Enrollment: 60
Locations: 1
Primary Endpoint: Major pathologic response (MPR)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study targeted patients with resectable stage II-IIIA non-small cell lung cancer with EGFR mutation

Registry

clinicaltrials.gov

Start Date

November 7, 2024

End Date

December 31, 2028

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Peng Zhang

Responsible Party

Sponsor Investigator

Principal Investigator

Peng Zhang

Archiater

Shanghai Pulmonary Hospital, Shanghai, China

Eligibility Criteria

Inclusion Criteria

•NSCLC patient with EGFR sensitive mutation as confirmed by needle biopsy;
•At stage II-IIIA (TNM Staging, Version 8) as identified by chest CT, PET-CT or/and EBUS;
•No systemic metastasis (confirmed by head MRI, whole body bone scan, PET-CT, liver and adrenal CT, etc.);
•With the feasibility to receive radical surgery ;
•Good lung function that could tolerate surgical treatment;
•Aged 18-75 years;
•At least one measurable tumor foci (the longest diameter measured by CT shall be \> 10 mm);
•Other major organs shall function well (liver, kidney, blood system, etc.):
•ECOG PS score shall be 0-1;
•The child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. The child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial;

Exclusion Criteria

•The patient has undergone any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.;
•The patient suffers from any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that starts to attack within the last 3 months, congestive heart failure \[≥ Grade II specified by New York Heart Association (NYHA)\], cardiac infarction (6 months before enrollment), severe arrhythmia and liver, kidney or metabolic diseases that requires drug treatment;
•The patient is a carrier of HIV;
•The patient has had or is currently suffering from interstitial lung disease;
•The patient had undergone other major systemic operations or suffered from severe trauma within 3 months before the trial;
•The patient is allergic to befotertinib or its any excipients;
•The patient is allergic to bevacizumab or its any excipients;
•The patient is allergic to platinum-based double chemotherapy or its any excipients;
•The female patient is in pregnancy or lactation period;
•There are any conditions under which the investigator considers the patient is not suitable to be enrolled.

Arms & Interventions

Befotertinib combined Bevacizumab

Intervention: Befotertinib combined Bevacizumab

Befotertinib combined platinum-based double chemotherapy

Intervention: Befotertinib combined platinum-based double chemotherapy

Outcomes

Primary Outcomes

Major pathologic response (MPR)

Time Frame: up to 4 months

MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery