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NCT06755684RecruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 6 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
24 Dec 2024
Start date
7 Nov 2024
Primary completion date
31 Dec 2025
Lead sponsor
Peng Zhang
Diseases
Lung cancer
NCT number
NCT06755684

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 60
  • From 7 Nov 2024 to the primary completion date, 31 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 had undergone other major systemic operations or suffered from severe trauma within 3 months before the trial;

Other illness

  • 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 is a carrier of HIV;
  • The patient has had or is currently suffering from interstitial lung disease;
  • 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;
  • There are any conditions under which the investigator considers the patient is not suitable to be enrolled.

Other

  • The female patient is in pregnancy or lactation period;

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai Pulmonary Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.