RecruitingPhase 2NCT07181499

Sequential Chemotherapy With Befotertinib in Non-Small Cell Lung Cancer (NSCLC) Patients With Resistance to Third-Generation EGFR-TKI

A Study Evaluating the Efficacy and Safety of Pemetrexed Combined With Platinum-Based Chemotherapy Followed by Befotertinib in Patients With Non-Small Cell Lung Cancer After Third-Generation EGFR TKI Resistance

Sponsor

Betta Pharmaceuticals Co., Ltd.

Enrollment

28 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

NSCLC EGFR Adjuvant Drug Therapy

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment strategy for people with non-small cell lung cancer (NSCLC) whose cancer has developed resistance to third-generation EGFR-targeted therapy (such as osimertinib). It combines chemotherapy with a drug called befotertinib to overcome this resistance. **You may be eligible if...** - You are 18 or older - You have non-squamous non-small cell lung cancer confirmed by biopsy or cytology - Your cancer has a common EGFR mutation (exon 19 deletion or L858R) and has stopped responding to a third-generation EGFR inhibitor - Your performance status is good (ECOG 0-2) - You have a life expectancy of at least 12 weeks - You are able to swallow oral medications **You may NOT be eligible if...** - Your cancer has transformed to small cell lung cancer or squamous cell carcinoma - Your cancer has other specific driver mutations that have their own targeted treatments (such as HER2, MET, ALK, RET, BRAF, KRAS, NTRK) - You have serious organ function problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBefotertinib

Befotertinib was administered orally at a starting dose of 75 mg per day for 21 days, which could be increased to 100 mg per day if grade 2 or higher thrombocytopenia or headache did not occur within 21 days, or maintained at the original dose (75 mg per day) if grade 2 or higher thrombocytopenia or headache occurred within 21 days.

DRUGPemetrexed + Carboplatin

pemetrexed (500 mg/m²) and carboplatin (AUC 5), administered every 3 weeks, for a total of 2\~4 cycles.

Locations(2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The Cancer Center of The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

View Full Details on ClinicalTrials.gov

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NCT07181499

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