Befotertinib treatment for early-stage lung cancer patients after surgery

A Prospective Study of Befotertinib Adjuvant Therapy in Patients With Postoperative MRD-positive Non-small Cell Lung Cancer in Stage IA2-IB With High Risk Factors

This study is testing if a new treatment called befortertinib can help early-stage lung cancer patients who have had surgery stay cancer-free for longer.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 592 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (other)
• Drugs / interventions: befortinib
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06561620 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of befortertinib as an adjuvant therapy in patients with stage IA2-IB non-small cell lung cancer (NSCLC) who have undergone complete surgical resection. The focus is on patients with minimal residual disease (MRD) and EGFR-sensitive mutations, assessing their 3-year disease-free survival rates. Participants will be monitored under routine observation to determine the impact of the treatment on their long-term outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with lung adenocarcinoma who have undergone complete resection and have MRD-positive EGFR-sensitive mutations.

Not a fit: Patients with non-EGFR-sensitive mutations or those who have not undergone complete resection may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve disease-free survival rates for patients with early-stage NSCLC.

How similar studies have performed: While there have been studies on adjuvant therapies for NSCLC, the specific use of befortertinib in this context is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Age: 18-75 years old.
2. Gender: both men and women are acceptable, as balanced as possible.
3. 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.
4. 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.

4\. 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.

5\. The ECOG behavioral status score is 0 to 1, and the expected survival time is \> 1 year.

6\. Voluntary MRD screening and voluntary befortinib adjuvant therapy; 7. Have a certain organ system function, defined as follows, based on the researcher's experience A. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L B. Platelets ≥ 100 x 109/L; C. Hemoglobin ≥ 9 g/dL (≥ 90 g/L) Note that in order to achieve the required hemoglobin level, blood transfusion is allowed; D. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); E. If there is no liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; if liver metastasis, ≤ 5 × ULN; F. Creatinine ≤ 1.5 x ULN. Patients are still eligible for inclusion if the creatinine clearance value calculated by the Cockcroft-Gault method is ≥ 50 mL/min (0.83 mL/s).

8\. 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.

9\. Voluntary and capable of following the test and follow-up procedures. 10. Sign the informed consent form.

Exclusion Criteria:

1. There is any other treatment before the operation, and no informed consent is signed;
2. The patient has been diagnosed with cancer within 2 years;
3. 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.
4. Patients who are known to be allergic to any component of befortinib or similar drugs;
5. Pregnant or lactating women;
6. Situations considered unsuitable for inclusion by other researchers.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Cancer Center — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Hang Li

Conditions: 3-year Disease-free Survival