Befotertinib Adjuvant Therapy in Stage IA2-IB NSCLC Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Befotertinib.
- Who it may be relevant to
- Registry conditions: 3-year Disease-free Survival. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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).
Interventions
- Drug Befotertinib
Befotertinib is a novel, selective oral third-generation epidermal growth factor receptor tyrosine-kinase inhibitor.
Primary outcome measures
- 3-year disease-free survival [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- 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.
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
- 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;
- Situations considered unsuitable for inclusion by other researchers.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Cancer Center — Shanghai
Identifiers
NCT: NCT06561620 · ECTOP-1024