Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer

Launched by PENG ZHANG · Dec 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a combination of new treatments for patients with a specific type of lung cancer called non-small cell lung cancer (NSCLC) that has a mutation in the EGFR gene. The trial is focusing on patients whose cancer is at an early stage (II-IIIA) and can be surgically removed. Researchers want to see if adding a medication called befotertinib to standard chemotherapy and another drug called bevacizumab can improve treatment outcomes before surgery.

To be eligible for this trial, participants must be between 18 and 75 years old and have confirmed NSCLC with an EGFR mutation. They need to have good lung function and no signs of cancer spreading to other parts of the body. Participants will undergo various tests to ensure they are healthy enough for surgery and the trial treatments. If you or someone you know is considering joining, it's important to discuss it with a healthcare provider to understand the potential benefits and risks involved.

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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.