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| Name | Class |
|---|---|
| Guangdong Provincial Hospital of Traditional Chinese Medicine | OTHER |
| Beijing Chest Hospital | OTHER |
| Guang'anmen Hospital of China Academy of Chinese Medical Sciences | OTHER |
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This is a multicenter, phase II exploratory clinical trial in untreated patients with EGFR-mutant non-small cell lung cancer (stages IIIB-IV) .All participants will receive oral befotertinib monotherapy for 3 weeks first, then serial minimal residual disease (MRD/MRD) testing is performed to adjust subsequent treatment. Patients with positive MRD will receive 4 cycles of pemetrexed plus platinum chemotherapy; patients with negative MRD will continue single-agent befotertinib. After induction, maintenance therapy will be given according to follow-up MRD results. The primary goal is to evaluate progression-free survival guided by dynamic MRD monitoring, and secondary endpoints include objective response rate, disease control rate, safety and MRD clearance rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Befotertinib with chemotherapy guided by dynamic MRD monitoring | Experimental | All participants receive oral befotertinib 75 mg once daily for 3 weeks as induction therapy, followed by MRD detection. Treatment is adjusted dynamically based on serial MRD results: MRD-positive patients get 4 cycles of befotertinib plus pemetrexed-platinum chemotherapy; MRD-negative patients continue single-agent befotertinib. Subsequent MRD tests every 12 weeks guide treatment adjustment: patients who have not previously received pemetrexed -platinum chemotherapy and convert to MRD-positive will receive 4 cycles of befotertinib plus pemetrexed-platinum chemotherapy; patients who have previously received pemetrexed-platinum chemotherapy will receive single agent befotertinib if MRD-negative or befotertinib plus pemetrexed maintenance if MRD-positive.Treatment cycles are 21 days, continued until disease progression, intolerable toxicity, withdrawal of consent or death. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Befotinib | Drug | Oral administration, initial dose 75 mg once daily; dose adjusted to 100 mg once daily based on safety and clinical benefit. Used as induction, single-agent maintenance, or combined with chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Time from first dose of study treatment to first radiographically confirmed isease progression according to RECIST version 1.1 or death from any cause, whichever occurs first. | Up to 48 months after the last participant enrollment,including at least 24 months of follow-up after the last participant is enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Overall Survival (OS) | Defined as the time from first dose of study treatment to death from any cause. | Including at least 24 months of follow-up after the last participant is enrolled.Participants lost to follow-up will be censored at the last date they were known to be alive. |
| Objective response rate (ORR) |
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Inclusion Criteria:
Histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC).
Age ≥18 years, any gender.
Confirmed EGFR exon 19 deletion or exon 21 (L858R) substitution mutation by central laboratory or site-validated testing assay.
No prior systemic anti-tumor therapy.
ECOG performance status 0-2.
Expected survival ≥12 weeks.
Able to swallow oral study medication.
At least one measurable lesion per RECIST 1.1 criteria.
Adequate organ function as defined below:
Fertile men and women agree to effective contraception during study treatment and for specified time after last dose.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoshu Chai, MD | Contact | +8613570301605 | chaixiaoshu@126.com | |
| Yanjuan Zhu, MD | Contact | +8613902260217 | zyjsophy@gzucm.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoshu Chai, MD | Guangdong Provincial Hospital of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Chinese Medicine | Guangzhou | Guangdong | 510120 | China |
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| Sichuan Cancer Hospital and Research Institute |
| OTHER |
| Yueyang Hospital of Integrated Traditional Chinese and Western Medicine | OTHER |
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
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| Pemetrexed + Cisplatin /Carboplatin | Drug | This is induction combination chemotherapy for MRD-positive patients after initial befotinib monotherapy. Pemetrexed at 500 mg/m² is given intravenously on Day 1 of each 21-day cycle, combined with either Cisplatin (75 mg/m² IV Day 1) or Carboplatin (AUC 5 IV Day 1) at investigator's discretion based on patient renal function and tolerability, for up to 4 cycles. Standard premedication with folic acid, vitamin B12 and dexamethasone is administered per pemetrexed prescribing guidelines. |
|
Defined as the proportion of participants achieving confirmed complete response (CR) or partial response (PR) per RECIST version 1.1. |
| including at least 24 months of follow-up after the last participant is enrolled. |
| Disease control rate (DCR) | defined as the proportion of participants achieving confirmed complete response (CR), partial response (PR) or stable disease (SD) per RECIST version 1.1. | including at least 24 months of follow-up after the last participant is enrolled. |
| Time to intolerable toxicity | Defined as the time from the first dose of study treatment to the first occurrence of treatment-related intolerable adverse event leading to permanent discontinuation of study therapy. | Including at least 24 months of follow-up after the last participant is enrolled. |
| ID | Term |
|---|---|
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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