A Study of YH25448 in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
|ClinicalTrials.gov Identifier: NCT04075396|
Recruitment Status : Suspended (Recruitment temporarily on hold due to COVID-19 situation.)
First Posted : August 30, 2019
Last Update Posted : June 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: YH25448||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of YH25448 in Patients With EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)|
|Actual Study Start Date :||October 16, 2019|
|Estimated Primary Completion Date :||August 1, 2021|
|Estimated Study Completion Date :||November 23, 2021|
Experimental: Part D: Outside of Korea
Participants from outside of Korea with progressive disease and on prior epidermal growth factor receptor (EGFR) Tyrosine kinase inhibitor (TKI) therapy will receive recommended phase 2 doses based on safety, tolerability, efficacy and pharmacokinetics (PK) of YH25448.
Participants will receive YH25448 tablets once daily.
- Part D: Number of Participants with Adverse Event as a Measure of Safety and Tolerability [ Time Frame: Up to 2 years ]An adverse event is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
- Part D: Plasma Concentration of YH25448 After Administration of Single Dose (SD) [ Time Frame: Up to 2 years ]Plasma Concentration of YH25448 after administration of single dose will be evaluated.
- Part D: Plasma Concentration of YH25448 After Administration of Multiple Dose (MD) [ Time Frame: Up to 2 years ]Plasma Concentration of YH25448 after administration of multiple dose will be evaluated.
- Part D: Plasma Concentration of YH25448 Metabolites (M6 and M7) After Administration of Single and Multiple Dose [ Time Frame: Up to 2 years ]Plasma Concentration of YH25448 metabolites (M6 and M7) after administration of single and multiple dose will be evaluated.
- Part D: Overall Response Rate (ORR) [ Time Frame: Up to 2 years ]ORR is defined as the percentage of participants who have at least one confirmed Partial response (PR) or Complete response (CR) (according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) prior to disease progression or recurrence. CR is defined when all target lesions (TLs) and non-target lesions (NTLs) present at baseline have disappeared (with the exception of lymph nodes which must be less than (<)10 millimeters (mm) to be considered non-pathological) and no new lesions have developed since baseline. PR is defined when the sum of diameters of the TLs has decreased by 30 percent (%) or more compared to baseline (with no evidence of progression) and the NTLs are at least stable with no evidence of new lesions.
- Part D: Duration of Response (DoR) [ Time Frame: Up to 2 years ]DoR is defined as the time from the date of first documented responses until date of documented progression or death whichever comes first.
- Part D: Disease Control Rate (DCR) [ Time Frame: Up to 2 years ]DCR is defined as the percentage of participants with a best overall, extracranial and intracranial response of CR, PR or Stable Disease (SD). CR is defined as disappearance of all target lesions since baseline. Any pathological lymph nodes selected as target lesions must have a reduction in short axis to < 10 mm. PR is defined as At least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters. SD is defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm for extracranial and intracranial lesion, respectively.
- Part D: Tumor Shrinkage [ Time Frame: Up to 2 years ]Tumor shrinkage is measured at each visit by the percentage change in the sum of the diameters of target lesions compared to baseline measured as greater than or equal to (>=) 10 mm in the longest lesion diameter with computed tomography (CT) or magnetic resonance imaging (MRI).
- Part D: Progression Free Survival (PFS) [ Time Frame: Up to 2 years ]PFS is defined as the time from first dosing date until documented disease progression or death from any cause whichever occur first based on investigator assessment using RECIST 1.1. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm for extracranial and intracranial lesion, respectively.
- Part D: Overall Survival (OS) [ Time Frame: Up to 2 years ]OS is defined as the interval between the date of first dose and the date of participants death due to any cause.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075396
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|United States, Florida|
|Advent Health Orlando|
|Orlando, Florida, United States, 32804|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10461|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37211|
|Hosp. Univ. Vall D'Hebron|
|Barcelona, Spain, 8035|
|Hosp. Gral. Univ. Gregorio Marañon|
|Madrid, Spain, 28009|
|Hosp. Virgen de La Victoria|
|Malaga, Spain, 29010|
|Sarah Cannon Research Institute|
|London, United Kingdom, W1G 6AD|
|The Christie Nhs Foundation Trust|
|Manchester, United Kingdom, M20 4BX|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|