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

NCT06755684 | Recruiting Phase 2 DMC

• 1 other identifier: LungMate-021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

EGFR; Non-Small Cell Lung Cancer; Locally Advanced Non-Small Cell Lung Cancer; Pemetrexed; Carboplatin; Bevacizumab; Antineoplastic Agents; Tyrosine Kinase Inhibitor

Keywords

EGFR-TKI; NSCLC; Chemotherapy; Bevacizumab; Locally advanced non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Major pathologic response (MPR)

  MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery

  up to 4 months

Secondary Outcomes (8)

• Objective response rate (ORR)

  Up to 4 months

• Progression-free survival (PFS)

  up to 60 months

• Event-free survival (EFS)

  Up to 60 months

• Disease-free survival (DFS)

  up to 60 months

• Overall survival (OS)

  up to 60 months

Study Arms (2)

Befotertinib combined Bevacizumab

EXPERIMENTAL

Befotertinib combined Bevacizumab

Drug: Befotertinib combined Bevacizumab

Befotertinib combined platinum-based double chemotherapy

EXPERIMENTAL

Befotertinib combined platinum-based double chemotherapy

Drug: Befotertinib combined platinum-based double chemotherapy

Interventions

Befotertinib combined Bevacizumab DRUG

Befotertinib combined Bevacizumab

Befotertinib combined Bevacizumab

Befotertinib combined platinum-based double chemotherapy DRUG

Befotertinib combined platinum-based double chemotherapy

Befotertinib combined platinum-based double chemotherapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peng Zhang: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Peng Zhang

CONTACT

02165115006; zhangpeng1121@tongji.edu.cn

Yue Liu

CONTACT

18831402353@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Archiater

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 1, 2025
• Study Start: November 7, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 6, 2025

Record last verified: 2025-01

Locations

CN (1)