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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-07

Study Completion Date

2028-12-31

Brief Summary

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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Befotertinib combined Bevacizumab

Group Type EXPERIMENTAL

Befotertinib combined Bevacizumab

Intervention Type DRUG

Befotertinib combined Bevacizumab

Befotertinib combined platinum-based double chemotherapy

Group Type EXPERIMENTAL

Befotertinib combined platinum-based double chemotherapy

Intervention Type DRUG

Befotertinib combined platinum-based double chemotherapy

Interventions

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Befotertinib combined Bevacizumab

Intervention Type DRUG

Befotertinib combined platinum-based double chemotherapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No