Phase 2Terminated
Lazertinib/Pemetrexed/Carboplatin After Osimertinib Failure in NSCLC With Brain Metastases
Phase II Trial of Lazertinib and Pemetrexed/Carboplatin Combination in Patients With EGFR Positive, Metastatic NSCLC With Asymptomatic or Mild Symptomatic Brain Metastases After Failure of Osimertinib
- Sponsor
- Jin Hyoung Kang (Academic or other)
- Enrolment
- 14 enrolled
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Lazertinib; Pemetrexed; Carboplatin
- Ages
- adults, older adults
- Registry
- NCT05477615
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- intracranial objective response rate
History
Last registry update
Primary completion
Started
Registered