Ignite Creation Date:
2024-05-06 @ 5:55 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05477615
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-07-28
First Post:
2022-07-17
Brief Title:
LazertinibPemetrexedCarboplatin After Osimertinib Failure in NSCLC With Brain Metastases
Sponsor:
Jin Hyoung Kang
Organization:
Seoul St Marys Hospital
Study Overview
Official Title:
Phase II Trial of Lazertinib and PemetrexedCarboplatin Combination in Patients With EGFR Positive Metastatic NSCLC With Asymptomatic or Mild Symptomatic Brain Metastases After Failure of Osimertinib
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to evaluate the intracranial efficacy of pemetrexedcarboplatin 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 500mgm2 Carboplatin AUC x 5 mgmLmin 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
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 500mgm2 Carboplatin AUC x 5 mgmLmin 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
Detailed Description:
The primary objective is to evaluate the intracranial efficacy of pemetrexedcarboplatin 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 defined as the proportion of patients achieving a complete response or partial response of intracranial lesions per RECIST v11 by investigators assessments 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
Intracranial objective response rate iORR percentage of subjects with at least one confirmed response CR or PR or responding in the intracranial lesion before evidence of progression in patients with brain metastases Intracranial progression free survival iPFS From C1D1 to the date of either disease progression of intracranial lesions or death Objective response rate ORR proportion of patients achieving a complete response or partial response of overall lesions Duration of response DoR From the first recorded response to the first recorded disease progression or death Disease control rate DCR proportion of patients achieving a complete response or partial response or stable disease of overall lesions Overall survival From C1D1 to the date of all-cause mortality Safety Evaluated by NCI-CTCAE v50 Pattern of treatment failure intracranial progression extracranial progression or both Intracranial salvage treatment rate Percentage of subjects who underwent salvage treatmentsurgery or radiation due to intracranial disease progression
The exploratory objective is to identify molecular profiling using next generation sequencing
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 500mgm2 Carboplatin AUC x 5 mgmLmin 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 To prevent side effects of pemetrexed start at least 7 days before cycle 1 daily dose of 350-1000 μgday of folic acid and 1000 μg3 of vitamin B12
Intracranial objective response rate iORR percentage of subjects with at least one confirmed response CR or PR or responding in the intracranial lesion before evidence of progression in patients with brain metastases Intracranial progression free survival iPFS From C1D1 to the date of either disease progression of intracranial lesions or death Objective response rate ORR proportion of patients achieving a complete response or partial response of overall lesions Duration of response DoR From the first recorded response to the first recorded disease progression or death Disease control rate DCR proportion of patients achieving a complete response or partial response or stable disease of overall lesions Overall survival From C1D1 to the date of all-cause mortality Safety Evaluated by NCI-CTCAE v50 Pattern of treatment failure intracranial progression extracranial progression or both Intracranial salvage treatment rate Percentage of subjects who underwent salvage treatmentsurgery or radiation due to intracranial disease progression
The exploratory objective is to identify molecular profiling using next generation sequencing
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 500mgm2 Carboplatin AUC x 5 mgmLmin 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 To prevent side effects of pemetrexed start at least 7 days before cycle 1 daily dose of 350-1000 μgday of folic acid and 1000 μg3 of vitamin B12
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None