Neoadjuvant Furmonertinib Plus Bevacizumab or Furmonertinib Monotherapy for Resectable and Potentially Resectable Stage III-IVA EGFR Mutation-Positive Lung Adenocarcinoma

Launched by SHANGHAI PULMONARY HOSPITAL, SHANGHAI, CHINA · Aug 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for patients with a specific type of lung cancer called lung adenocarcinoma that has positive EGFR mutations, which can make the cancer more aggressive. The researchers want to see how effective and safe a combination of two drugs, furmonertinib and bevacizumab, is when given before surgery (this is called neoadjuvant therapy) compared to using furmonertinib alone. The trial is open to adults over 18 who have stage III-IVA lung adenocarcinoma that can potentially be removed through surgery, and who have good lung function and overall health.

To participate, patients must have a confirmed EGFR mutation, no spread of cancer to other parts of the body, and at least one measurable tumor. Importantly, participants will need to sign a consent form agreeing to take part in the study. Throughout the trial, patients can expect close monitoring for their health and any side effects from the medications. Additionally, women of childbearing age will need to take pregnancy tests and use effective birth control during the study. This trial is currently recruiting participants, and it aims to provide insights that could improve treatment options for this type of lung cancer.

Gender

ALL

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.