Combining Befotertinib with Bevacizumab or Chemotherapy for Lung Cancer Treatment

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

This study is testing if a new lung cancer treatment combining befotertinib with either bevacizumab or chemotherapy can help patients with early-stage cancer that has an EGFR mutation feel better before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China (Academic / other)
• Drugs / interventions: bevacizumab, befotertinib, chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06755684 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of befotertinib, an EGFR-TKI, in combination with either bevacizumab or platinum-based double chemotherapy for patients with resectable stage II-IIIA non-small cell lung cancer (NSCLC) that has an EGFR mutation. The study aims to assess the safety and efficacy of these combinations prior to surgical intervention. Eligible participants will undergo various imaging tests to confirm their cancer stage and ensure they do not have systemic metastasis. The trial focuses on patients who are capable of tolerating surgery and have measurable tumor foci.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with resectable stage II-IIIA NSCLC and confirmed EGFR sensitive mutations.

Not a fit: Patients with systemic metastasis or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve surgical outcomes and overall survival rates for patients with advanced EGFR mutation-positive NSCLC.

How similar studies have performed: Other studies have shown promising results with similar combinations of targeted therapies and chemotherapy in treating NSCLC, indicating potential for success.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Peng Zhang

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