Lazertinib/Pemetrexed/Carboplatin After Osimertinib Failure in NSCLC With Brain Metastases

Sponsor
Jin Hyoung Kang
Study ID
NCT05477615
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lazertinib — DRUG
    \- Lazertinib 240mg (3 tablets, 80mg/1tablet) once a day, oral, before disease progression
  • Pemetrexed — DRUG
    \- Pemetrexed 500mg/m2 is administered on the 1st day every 3 weeks. One cycle of treatment is defined as continuous administration for 21 days. Pemetrexed and carboplatin can be administered in reduced doses according to the principles of each institution.
  • Carboplatin — DRUG
    \- Carboplatin AUC x 5 mg/mL.min is administered on the 1st day every 3 weeks. One cycle of treatment is defined as continuous administration for 21 days. Pemetrexed and carboplatin can be administered in reduced doses according to the principles of each institution.

Study Details

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.

Key Dates

Start date
Aug 31, 2022
Status verified
Jul 2022
Primary completion
Jun 30, 2023
Completion
Jun 30, 2025

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: lazertinib/pemetrexed/carboplatin
    combination of lazertinib with pemetrexed/carboplatin chemotherapy \- Lazertinib 240mg once daily and chemotherapy (pemetrexed and carboplatin) is administered on the 1st day every 3 weeks.

Primary Outcome Measure

intracranial objective response rate [ Time Frame: "every 6 weeks up to 24 weeks, and every 12 weeks thereafter up to 2 years " ]

Central Contacts

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