Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05503667

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

Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2022-08-17

96

Participants Needed

1

Research Sites

360 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To explore the efficacy and safety of neoadjuvant furmonertinib combined with bevacizumab in the treatment of resectable and potentially resectable stage III-IVA EGFR mutation-positive lung adenocarcinoma.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China, 200433

Actively Recruiting

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Research Team

P

Peng Zhang, MD,PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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