C4221008 - A Phase 2, Open-label Study of Encorafenib + Binimetinib in Patients with BRAFV600-mutant Non-small Cell Lung Cancer

Conditions

Non-small Cell Lung Cancer

Brief summary

ORR defined as the proportion of patients who have achieved a confirmed best overall response (CR or PR) as determined by IRR per RECIST v1.1 in the treatment-naïve setting, ORR defined as the proportion of patients who have achieved a confirmed best overall response (CR of PR) as determined by IRR per RECIST v1.1 in the previously treated setting

Detailed description

Confirmed ORR by Investigator per RECIST v1.1, DOR (by IRR and by Investigator) defined as the time from the date of the first documented response (CR or PR) that is subsequently confirmed(by IRR and by Investigator, respectively) to the earliest date of disease progression, per RECIST v1.1, or death due to any cause, DCR (by IRR and by Investigator), defined as the proportion of patients who have a confirmed CR or confirmed PR, or SD per RECIST v1.1, PFS (by IRR and by Investigator), defined as the time from the date of first dose of study drug to the earliest date of disease progression, per RECIST v1.1, or death due to any cause., TTR (by IRR and Investigator), defined as the time from the date of first dose to the first documentation of objective response (CR or PR) which is subsequently confirmed (by IRR and by Investigator, respectively)

Related papers

No related papers found yet.

Interventions

DRUGEncorafenib

DRUGMektovi 15 mg film-coated tablets

DRUGBraftovi 75 mg hard capsules

DRUGBraftovi 50 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
ORR defined as the proportion of patients who have achieved a confirmed best overall response (CR or PR) as determined by IRR per RECIST v1.1 in the treatment-naïve setting, ORR defined as the proportion of patients who have achieved a confirmed best overall response (CR of PR) as determined by IRR per RECIST v1.1 in the previously treated setting	—

Secondary

Measure	Time frame
Confirmed ORR by Investigator per RECIST v1.1, DOR (by IRR and by Investigator) defined as the time from the date of the first documented response (CR or PR) that is subsequently confirmed(by IRR and by Investigator, respectively) to the earliest date of disease progression, per RECIST v1.1, or death due to any cause, DCR (by IRR and by Investigator), defined as the proportion of patients who have a confirmed CR or confirmed PR, or SD per RECIST v1.1, PFS (by IRR and by Investigator), defined as the time from the date of first dose of study drug to the earliest date of disease progression, per RECIST v1.1, or death due to any cause., TTR (by IRR and Investigator), defined as the time from the date of first dose to the first documentation of objective response (CR or PR) which is subsequently confirmed (by IRR and by Investigator, respectively)	—

Measure

Time frame

Confirmed ORR by Investigator per RECIST v1.1, DOR (by IRR and by Investigator) defined as the time from the date of the first documented response (CR or PR) that is subsequently confirmed(by IRR and by Investigator, respectively) to the earliest date of disease progression, per RECIST v1.1, or death due to any cause, DCR (by IRR and by Investigator), defined as the proportion of patients who have a confirmed CR or confirmed PR, or SD per RECIST v1.1, PFS (by IRR and by Investigator), defined as the time from the date of first dose of study drug to the earliest date of disease progression, per RECIST v1.1, or death due to any cause., TTR (by IRR and Investigator), defined as the time from the date of first dose to the first documentation of objective response (CR or PR) which is subsequently confirmed (by IRR and by Investigator, respectively)

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Countries

Italy, Netherlands, Spain

Outcome results

None listed