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

NCT05503667 | Recruiting Phase 2

• 1 other identifier: LungMate-012
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Adenocarcinoma Stage III; Lung Adenocarcinoma Stage IV; EGFR Gene Mutation

Keywords

neoadjuvant chemoimmunotherapy

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  It refers to the proportion of patients who have had a complete response or partial response (according to RECIST1.1) as confirmed by CT evaluation after 3 weeks in all patients who have completed the neoadjuvant therapy. Only patients with measurable lesions at baseline will be analyzed.

  up to 21 months

Secondary Outcomes (8)

• Disease-free survival (DFS)

  up to 54 months

• Overall survival (OS)

  up to 60 months

• Health related quality of life (HRQol)

  up to 6 months

• Progression-free survival (PFS)

  up to 54 months

• R0 resection

  up to 24 months

Study Arms (2)

Furmonertinib Plus Bevacizumab

EXPERIMENTAL

Furmonertinib Plus Bevacizumab

Drug: Furmonertinib; Drug: Bevacizumab

Furmonertinib

ACTIVE COMPARATOR

Furmonertinib monotherapy

Drug: Furmonertinib

Interventions

Furmonertinib DRUG

Furmonertinib 80 mg/day for 16 weeks

Also known as: Ivesa

Furmonertinib; Furmonertinib Plus Bevacizumab

Bevacizumab DRUG

bevacizumab 400 mg/4 weeks i.v. for 4 times

Also known as: Avastin

Furmonertinib Plus Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

aflutinib; Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Peng Zhang, MD,PhD

CONTACT

+8613512185932; zhangpeng1121@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of science and education department

Study Record Dates

• First Submitted: August 13, 2022
• First Posted: August 17, 2022
• Study Start: February 1, 2022
• Primary Completion: October 1, 2023
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)