Befotertinib Adjuvant Therapy in Stage IA2-IB NSCLC Patients

NCT06561620 | Recruiting Phase 4

• 1 other identifier: ECTOP-1024
• Study Type: interventional
• Target: 592
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate 3-year disease-free survival after complete resection in patients with MRD-positive EGFR-sensitive mutations in Stage IA2-IB NSCLC treated with adjuvant befortinib and under routine observation (3y-DFS).

Conditions

3-year Disease-free Survival

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival

  3-year disease-free survival after complete resection in patients with MRD-positive EGFR-sensitive mutations in Stage IA2-IB NSCLC

  3 years

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Drug: Befotertinib

Observation

NO INTERVENTION

Interventions

Befotertinib DRUG

Befotertinib is a novel, selective oral third-generation epidermal growth factor receptor tyrosine-kinase inhibitor.

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-75 years old.
• Gender: both men and women are acceptable, as balanced as possible.
• Patients with lung adenocarcinoma who underwent R0 resection and were clinically confirmed as IA2-IB by histopathology and whose tumor size was (1-4cm), the surgical tissue samples tested positive for EGFR-sensitive mutations and positive for MRD after surgery.
• Accompanied by arbitrary ≥ 2 high-risk factors; High risk factors such as pleural invasion, airway diffusion, vascular infiltration, low differentiation, pathological micropapillary composition ≥ 15%, complex glandular composition ≥ 20%, etc.
• \. Achieve R0 resection: For CTR \< 50% ground glass nodules, wedge resection is acceptable and the margin is negative, and 3 groups of lymph node biopsies are negative; for CTR ≥ 50% or pure solid nodules, at least segmental resection is undergone, and lymph node dissection is systematically performed; if there is no clear evidence of metastasis, if it cannot be judged, it can be determined by an independent review committee for pathological consultation.
• \. The ECOG behavioral status score is 0 to 1, and the expected survival time is \> 1 year.
• \. Female subjects of childbearing age must have a serum pregnancy test within 3 days before the start of the study drug, and the result is negative, and they are willing to use a medically approved high-efficacy contraceptive method (such as intrauterine devices, contraceptives or condoms) during the study period and within 3 months after the last administration of the study drug; for significant other male subjects who are women of childbearing age, they should be surgically sterilized, or agree to use effective methods of contraception during the study period and within 3 months after the last study dose.
• \. Voluntary and capable of following the test and follow-up procedures. 10. Sign the informed consent form.

You may not qualify if:

• There is any other treatment before the operation, and no informed consent is signed;
• The patient has been diagnosed with cancer within 2 years;
• Have a history of interstitial lung disease, drug-induced interstitial disease or any active interstitial lung disease with clinical evidence; CT scan at baseline revealed idiopathic pulmonary fibrosis.
• Patients who are known to be allergic to any component of befortinib or similar drugs;
• Pregnant or lactating women;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Central Study Contacts

Hang Li

CONTACT

+862164175590; drlihang@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the MDT board of thoracic cancer

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 20, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2029
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)