Treatment for advanced lung cancer using furmonertinib and bevacizumab

Neoadjuvant Furmonertinib Plus Bevacizumab or Furmonertinib Monotherapy for Resectable and Potentially Resectable Stage III-IVA EGFR Mutation-Positive Lung Adenocarcinoma: A Randomized, Controlled, Open-label, Single-center Phase II Clinical Trial

This study is testing a new combination of medications to see if it can help shrink tumors in patients with advanced lung cancer before surgery, making it easier to remove the cancer completely.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China (Academic / other)
• Drugs / interventions: bevacizumab, furmonertinib
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05503667 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of neoadjuvant therapy combining furmonertinib, a third-generation TKI, with bevacizumab for patients with resectable and potentially resectable stage III-IVA lung adenocarcinoma that has EGFR mutations. The goal is to shrink tumors prior to surgery, thereby increasing the chances of complete surgical resection and reducing recurrence risks. The study aims to provide higher-level clinical evidence regarding the benefits of this treatment approach, which includes induction therapy followed by surgery and adjuvant therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with resectable stage III-IVA lung adenocarcinoma and confirmed EGFR mutations.

Not a fit: Patients with systemic metastasis or those who cannot tolerate surgical treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve progression-free survival and overall outcomes for patients with advanced lung adenocarcinoma.

How similar studies have performed: Limited clinical research data suggest that neoadjuvant TKI therapy has shown promise, but this specific combination approach is still being evaluated.

Eligibility criteria

Inclusion Criteria:

* Lung adenocarcinoma patient with EGFR sensitive mutation as confirmed by needle biopsy;
* At stage III-IVA (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 feasiblility or potential feasibility to receive radical surgery (radical lung lobectomy+systematic lymph node dissection);
* Good lung function that could tolerate surgical treatment;
* Aged \>= 18 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 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 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 furmonertinib or its any excipients;
* The patient is allergic to bevacizumab 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, MD,PhD

Conditions Lung Adenocarcinoma Stage III; Lung Adenocarcinoma Stage IV; EGFR Gene Mutation; neoadjuvant chemoimmunotherapy