Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 8, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT05477615). This is a study registration, not published results. Lead sponsor: Jin Hyoung Kang. Recruitment status: TERMINATED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 14 participants (ACTUAL). Conditions: Non-small Cell Lung Cancer. Interventions: DRUG: Lazertinib; DRUG: Pemetrexed; DRUG: Carboplatin. Primary outcome measures: intracranial objective response rate , "every 6 weeks up to 24 weeks, and every 12 weeks thereafter up to 2 years ". Brief summary: The primary objective is to evaluate the intracranial efficacy of pemetrexed/carboplatin chemotherapy and lazertinib combination therapy after osimertinib failure in EGFR-positive non-small cell lung cancer patients with brain metastasis. The primary endpoint is the incracranial objective response rate (iORR). Secondary endpoints are intracranial progression free survival, (iPFS), objective response rate (ORR), duration of response (DoR), disease control rate, (DCR), overall survival (OS), the pattern of treatment failure, intracranial salvage treatment rate, and toxicity. Patients should take lazertinib 240 mg (80 mg, 3 tablets) once a day at the same time as possible before meals. Chemotherapy will be administered on the 1st day every 3 weeks. (Pemetrexed 500mg/m2, Carboplatin AUC x 5 mg/mL.min) One cycle of treatment is defined as continuous administration for 21 days. The treatment will be applied to the all patients until documented evidence of disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. If the investigator decides to reduce the dose due to an adverse reaction during the administration of lazertinib 240 mg, the dose may be reduced to 160 mg (80 mg, 2 tablets) of lazertinib. Pemetrexed and carboplatin can be administered in reduced doses according to the principles of each institution.