Actively Recruiting
Sequential Chemotherapy With Befotertinib in Non-Small Cell Lung Cancer (NSCLC) Patients With Resistance to Third-Generation EGFR-TKI
Led by Betta Pharmaceuticals Co., Ltd. · Updated on 2025-09-30
28
Participants Needed
2
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Non-small cell lung cancer (NSCLC) accounts for over 85% of lung cancers. Approximately 30-40% of East Asian adenocarcinoma patients harbor EGFR mutations. Third-generation EGFR-TKIs achieve a median PFS of about 20 months as first-line therapy, but resistance eventually develops. Studies like MARIPOSA-2 confirm that amivantamab combined with chemotherapy ± lazertinib or immunotherapy regimens (ivucitinib/sintilimab + bevacizumab + chemotherapy) can extend median PFS post-resistance from approximately 4 months to 6-8 months. As a third-generation TKI, befitinib has demonstrated PFS of 16-22 months in both first-line and post-T790M mutation settings. This study aims to further evaluate the feasibility and safety of "pemetrexed + carboplatin followed by befotertinib" for patients resistant to third-generation TKIs.
CONDITIONS
Official Title
Sequential Chemotherapy With Befotertinib in Non-Small Cell Lung Cancer (NSCLC) Patients With Resistance to Third-Generation EGFR-TKI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed advanced or metastatic non-squamous NSCLC with prior resistance to third-generation EGFR TKIs and EGFR-sensitive mutations (19 Del or 21 L858R)
- No transformation to small cell lung cancer or squamous cell carcinoma and no known targetable mutations like HER2, MET amplification, KRAS G12C, BRAF V600E, RET, ALK, or NTRK fusions
- ECOG performance status 0-2
- Life expectancy of at least 12 weeks
- Ability to swallow oral medications
- Adequate organ function including neutrophil count ≥1.5 x 10⁹/L, platelets ≥100 x 10⁹/L, hemoglobin ≥9 g/dL (blood transfusions allowed), total bilirubin ≤1.5 times upper limit of normal, liver enzymes ≤2.5 times ULN without liver metastases or ≤5 times ULN with liver metastases, and creatinine ≤1.5 times ULN or creatinine clearance ≥50 mL/min
- Female participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and for 3 months after the study
- Male participants with partners of childbearing potential must be sterilized or use effective contraception during and for 3 months after the study
- Willingness and ability to comply with study and follow-up procedures
- Ability to understand the trial and provide written informed consent
You will not qualify if you...
- Presence of rare EGFR mutations
- Prior treatment with pemetrexed and platinum-based chemotherapy
- Advanced or symptomatic brain metastases or leptomeningeal metastases
- Active hepatitis B, hepatitis C, HIV infection, or positive tests for syphilis
- Positive pregnancy test, pregnancy, lactation, or lack of effective contraception during and 3 months after treatment
- Use of drugs causing QTc prolongation, strong CYP3A inhibitors or inducers within 14 days before or during treatment
- Major surgery or immunotherapy within 4 weeks or radiotherapy within 2 weeks before first dose
- Tumor invasion of major vessels or high risk of fatal hemorrhage
- History or presence of interstitial lung disease or idiopathic pulmonary fibrosis
- Severe acute or chronic medical conditions affecting safety or study results
- Any other condition the investigator deems unsuitable for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
2
The Cancer Center of The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
Actively Recruiting
Research Team
S
Shaodong Hong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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