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

NCT05477615 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-07-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Lazertinib

\- Lazertinib 240mg (3 tablets, 80mg/1tablet) once a day, oral, before disease progression

DRUG

Pemetrexed

\- 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.

DRUG

Carboplatin

\- 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.

Sponsors & Collaborators

  • Korea University Anam Hospital

    collaborator OTHER

  • Jin Hyoung Kang

    lead OTHER

Principal Investigators

  • Jin Hyoung Kang · Seoul St. Mary's Hospital, The Catholic University of Korea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2023-06-30
Completion
2025-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05477615 on ClinicalTrials.gov