Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT07742332
NCT07742332RecruitingPhase 2

Targeted Induction Therapy for Stage III Unresectable EGFR Mutant Positive NSCLC: a Single-center, Randomized Controlled Trial

Peng Zhang1 site in 1 country160 target enrollmentStarted: November 25, 2025Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
160
Locations
1
Primary Endpoint
Progression-free survival (PFS)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The subjects of this study are patients with unresectable stage III non-small cell lung cancer (NSCLC) who have EGFR mutations.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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;
  • •Minimum age: 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.

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.

Outcomes

Primary Outcomes

Progression-free survival (PFS)

Time Frame: up to 60 months

It refers to the time (months) from the first administration of drug in this study to the disease progression or death (including any cause of death in the case of no progression) as recorded in CRF, regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression.

Secondary Outcomes

  • Major pathologic response (MPR)(up to 4 months)

Investigators

Sponsor
Peng Zhang
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Peng Zhang

Archiater

Shanghai Pulmonary Hospital, Shanghai, China

Study Sites (1)

Loading locations...

Similar Trials

Unknown
Not Applicable
张鹏医师：该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者，并与我们联系上传批件。 新辅助靶向或免疫治疗 III 期非小细胞肺癌的临床研究
ChiCTR2000032130上海肺科医院临床研究基金142
Not yet recruiting
Phase 3
Pivotal Study to Evaluate YL202 Versus Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung CancerNon-Small Cell Lung Cancer
NCT07416994MediLink Therapeutics (Suzhou) Co., Ltd.440
Not yet recruiting
Phase 1
A Clinical Study for the Efficacy and Safety of BL0020 Injection in Patients With Small Cell Lung Cancer Transformed From Non-Small Cell Lung Cancer Following EGFR TKI Therapy
NCT07414927Shanghai Best-Link Bioscience, LLC48
Recruiting
Phase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)Non-small Cell Lung Cancer
NCT07513376Merck Sharp & Dohme LLC876
Recruiting
Phase 3
A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D MutationNon-small Cell Lung Cancer (NSCLC)
NCT07566052Astellas Pharma Global Development, Inc.356