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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
Contact Information
Primary
Peng Zhang, MD,PhD
zhangpeng1121@outlook.com
+8613512185932
Time Frame
Start Date: 2022-02-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 96
Treatments
Experimental: Furmonertinib Plus Bevacizumab
Furmonertinib Plus Bevacizumab
Active_comparator: Furmonertinib
Furmonertinib monotherapy
Related Therapeutic Areas
Sponsors
Leads: Shanghai Pulmonary Hospital, Shanghai, China

This content was sourced from clinicaltrials.gov

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