Clinical trial NCT06755684: Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: EGFR
Non-Small Cell Lung Cancer
Locally Advanced Non-Small Cell Lung Cancer
Pemetrexed
Carboplatin
Bevacizumab
Antineoplastic Agents
Tyrosine Kinase Inhibitor
Keywords: EGFR-TKI
NSCLC
Chemotherapy
Bevacizumab
Locally advanced non-small cell lung cancer
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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;
* The patient shall sign the Informed Consent Form.

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.

Primary outcomes:
measure: Major pathologic response (MPR)
timeFrame: up to 4 months
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 4 months
measure: Progression-free survival (PFS)
timeFrame: up to 60 months
measure: Event-free survival (EFS)
timeFrame: Up to 60 months
measure: Disease-free survival (DFS)
timeFrame: up to 60 months
measure: Overall survival (OS)
timeFrame: up to 60 months
measure: R0 rate
timeFrame: up to 4 months
measure: adverse event (AE) rate
timeFrame: up to 4 months
measure: Complete Pathological response (CPR)
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
References: