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RECRUITINGPHASE2

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

Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer: a Single-center, Randomized Controlled Trial

NCT06755684•Peng Zhang

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;
+1 more criteria

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.

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

November 7, 2024

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2028

Last Updated

January 6, 2025

Enrollment

ESTIMATED participants

Conditions

EGFRNon-Small Cell Lung CancerLocally Advanced Non-Small Cell Lung CancerPemetrexedCarboplatinBevacizumabAntineoplastic AgentsTyrosine Kinase Inhibitor

Interventions

Befotertinib combined Bevacizumab

DRUG

Befotertinib combined platinum-based double chemotherapy

DRUG

Contacts

Peng Zhang

CONTACT

02165115006 zhangpeng1121@tongji.edu.cn

Yue Liu

CONTACT

18831402353@163.com

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

View study

RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)