Lazertinib/Pemetrexed/Carboplatin After Osimertinib Failure in NSCLC With Brain Metastases
Status:
Not yet recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
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.