Covid 19 Research using Clinical Trials (Home Page)
HP:0030358: Non-small cell lung carcinomaHPO
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (11)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug757 | Convalescent Plasma Transfusion Wiki | 1.00 |
| drug2366 | Random Donor Plasma Wiki | 0.71 |
| drug2508 | SBRT Wiki | 0.71 |
| drug3140 | YH25448 Wiki | 0.71 |
| drug3176 | anti-CD40 antibody Wiki | 0.71 |
| drug1074 | FLT3 Ligand Wiki | 0.71 |
| drug2765 | Supportive Care Wiki | 0.41 |
| drug1433 | Interferon Beta-1A Wiki | 0.35 |
| drug812 | DAS181 Wiki | 0.29 |
| drug1489 | Ivermectin Wiki | 0.16 |
| drug1284 | Hydroxychloroquine Wiki | 0.07 |
There are 2 clinical trials
Clinical Trials
1 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)
The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of YH25448 when given orally to participants with epidermal growth factor receptor single activating mutation positive (EGFRm+) locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC).
NCT04075396 Carcinoma, Non-Small-Cell Lung Drug: YH25448 MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma
Primary Outcomes
Description: 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.
Measure: Part D: Number of Participants with Adverse Event as a Measure of Safety and Tolerability Time: Up to 2 years
Description: Plasma Concentration of YH25448 after administration of single dose will be evaluated.
Measure: Part D: Plasma Concentration of YH25448 After Administration of Single Dose (SD) Time: Up to 2 years
Description: Plasma Concentration of YH25448 after administration of multiple dose will be evaluated.
Measure: Part D: Plasma Concentration of YH25448 After Administration of Multiple Dose (MD) Time: Up to 2 years
Secondary Outcomes
Description: Plasma Concentration of YH25448 metabolites (M6 and M7) after administration of single and multiple dose will be evaluated.
Measure: Part D: Plasma Concentration of YH25448 Metabolites (M6 and M7) After Administration of Single and Multiple Dose Time: Up to 2 years
Description: 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.
Measure: Part D: Overall Response Rate (ORR) Time: Up to 2 years
Description: DoR is defined as the time from the date of first documented responses until date of documented progression or death whichever comes first.
Measure: Part D: Duration of Response (DoR) Time: Up to 2 years
Description: 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.
Measure: Part D: Disease Control Rate (DCR) Time: Up to 2 years
Description: 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).
Measure: Part D: Tumor Shrinkage Time: Up to 2 years
Description: 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.
Measure: Part D: Progression Free Survival (PFS) Time: Up to 2 years
Description: OS is defined as the interval between the date of first dose and the date of participants death due to any cause.
Measure: Part D: Overall Survival (OS) Time: Up to 2 years
2 FLT3 Ligand, CD40 Agonist Antibody, and Stereotactic Radiotherapy Versus Standard Therapy for Advanced Non-small Cell Lung Cancer: A Phase I/II Randomized Trial
Primary Outcomes
Description: 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.
Measure: Part D: Number of Participants with Adverse Event as a Measure of Safety and Tolerability Time: Up to 2 yearsDescription: Plasma Concentration of YH25448 after administration of single dose will be evaluated.
Measure: Part D: Plasma Concentration of YH25448 After Administration of Single Dose (SD) Time: Up to 2 yearsDescription: Plasma Concentration of YH25448 after administration of multiple dose will be evaluated.
Measure: Part D: Plasma Concentration of YH25448 After Administration of Multiple Dose (MD) Time: Up to 2 yearsSecondary Outcomes
Description: Plasma Concentration of YH25448 metabolites (M6 and M7) after administration of single and multiple dose will be evaluated.
Measure: Part D: Plasma Concentration of YH25448 Metabolites (M6 and M7) After Administration of Single and Multiple Dose Time: Up to 2 yearsDescription: 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.
Measure: Part D: Overall Response Rate (ORR) Time: Up to 2 yearsDescription: DoR is defined as the time from the date of first documented responses until date of documented progression or death whichever comes first.
Measure: Part D: Duration of Response (DoR) Time: Up to 2 yearsDescription: 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.
Measure: Part D: Disease Control Rate (DCR) Time: Up to 2 yearsDescription: 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).
Measure: Part D: Tumor Shrinkage Time: Up to 2 yearsDescription: 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.
Measure: Part D: Progression Free Survival (PFS) Time: Up to 2 yearsDescription: OS is defined as the interval between the date of first dose and the date of participants death due to any cause.
Measure: Part D: Overall Survival (OS) Time: Up to 2 yearsThe purpose of this study is to test a new way of treating the most common form of lung cancer. The investigators are testing a combination of radiotherapy with two new forms of immunotherapy. This study is testing the safety and effectiveness of this treatment approach as compared to standard treatment options.
NCT04491084 Non Small Cell Lung Cancer Lung Cancer Drug: FLT3 Ligand Biological: anti-CD40 antibody Radiation: SBRT MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma
Primary Outcomes
Description: Death
Any ≥ Grade 3 non-hematological toxicity, with the following exceptions:
Grade 3 alopecia, vitiligo, or endocrinopathies controlled by hormone replacement therapy Grade 3 nausea that resolves to ≤ grade 2 with or without treatment within 72 hours Grade 3 vomiting and diarrhea that resolves to ≤ grade 2 with or without treatment within 72 hours Grade 3 fatigue that resolves to ≤ grade 2 within 5 days Grade 3 hypertension in the absence of maximal medical therapy Grade 3 adverse event of tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor) of ≤ 7 days in duration Grade 3 amylase or lipase abnormalities that are not associated with symptoms or clinical manifestations of pancreatitis. It is recommended to consult with the Principal Investigator for grade 4 amylase or lipase abnormalities
Grade 3 clinically significant laboratory abnormalities that are asymptomatic and can be reversed within 72 hours, however:
Any Grade 4
Measure: Phase I: Dose-limiting toxicity (DLT), defined as follows: Time: up to 8 weeks after initiation of study therapy
Measure: Phase II: Progression-free survival (PFS) duration Time: defined as time from study registration until disease progression (scored using iRECIST) or death, whichever comes first up to 51 weeks.
Secondary Outcomes
Description: Length of time that patient survives from time of study registration
Measure: Overall survival (OS) duration Time: From date of registration until the date of death from any cause, assessed up to 2 years
Description: The clinical benefit rate (CBR) will be defined as the percentage of subjects who achieve best response of confirmed CR or PR, or stable disease (SD) for at least four months.
Measure: Radiographic responses using descriptive statistics Time: From date of registration, assessed up to 4 months
Description: Summary statistics (mean, standard deviation, median, 25th and 75th percentiles, and range) and the mean change from baseline of linear-transformed scores will be reported for all the items and subscales of the EORTC QLQ-C30 questionnaire and the QLQ-LC13, according to the EORTC scoring manual guidelines. higher scores are a better level of functioning
Measure: Quality of Life using EORTC QLQ-LC13 (quality of Life Questionnaire, Lung Cancer) Time: 1 year
Description: Summary statistics (mean, standard deviation, median, 25th and 75th percentiles, and range) and the mean change from baseline of linear-transformed scores will be reported for all the items and subscales of the EORTC QLQ-C30 questionnaire and the QLQ-LC13, according to the EORTC scoring manual guidelines. Most items are scored 1 to 4, higher scores are a better level of functioning.
Measure: Quality of Life using QLQ-C30 (Quality of Life Questionnaire) Time: 1 year
Description: Average daily step counts
Measure: Daily step count using descriptive statistics Time: 1 year
HPO Nodes
Primary Outcomes
Description: Death Any ≥ Grade 3 non-hematological toxicity, with the following exceptions: Grade 3 alopecia, vitiligo, or endocrinopathies controlled by hormone replacement therapy Grade 3 nausea that resolves to ≤ grade 2 with or without treatment within 72 hours Grade 3 vomiting and diarrhea that resolves to ≤ grade 2 with or without treatment within 72 hours Grade 3 fatigue that resolves to ≤ grade 2 within 5 days Grade 3 hypertension in the absence of maximal medical therapy Grade 3 adverse event of tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor) of ≤ 7 days in duration Grade 3 amylase or lipase abnormalities that are not associated with symptoms or clinical manifestations of pancreatitis. It is recommended to consult with the Principal Investigator for grade 4 amylase or lipase abnormalities Grade 3 clinically significant laboratory abnormalities that are asymptomatic and can be reversed within 72 hours, however: Any Grade 4
Measure: Phase I: Dose-limiting toxicity (DLT), defined as follows: Time: up to 8 weeks after initiation of study therapyMeasure: Phase II: Progression-free survival (PFS) duration Time: defined as time from study registration until disease progression (scored using iRECIST) or death, whichever comes first up to 51 weeks.
Secondary Outcomes
Description: Length of time that patient survives from time of study registration
Measure: Overall survival (OS) duration Time: From date of registration until the date of death from any cause, assessed up to 2 yearsDescription: The clinical benefit rate (CBR) will be defined as the percentage of subjects who achieve best response of confirmed CR or PR, or stable disease (SD) for at least four months.
Measure: Radiographic responses using descriptive statistics Time: From date of registration, assessed up to 4 monthsDescription: Summary statistics (mean, standard deviation, median, 25th and 75th percentiles, and range) and the mean change from baseline of linear-transformed scores will be reported for all the items and subscales of the EORTC QLQ-C30 questionnaire and the QLQ-LC13, according to the EORTC scoring manual guidelines. higher scores are a better level of functioning
Measure: Quality of Life using EORTC QLQ-LC13 (quality of Life Questionnaire, Lung Cancer) Time: 1 yearDescription: Summary statistics (mean, standard deviation, median, 25th and 75th percentiles, and range) and the mean change from baseline of linear-transformed scores will be reported for all the items and subscales of the EORTC QLQ-C30 questionnaire and the QLQ-LC13, according to the EORTC scoring manual guidelines. Most items are scored 1 to 4, higher scores are a better level of functioning.
Measure: Quality of Life using QLQ-C30 (Quality of Life Questionnaire) Time: 1 yearDescription: Average daily step counts
Measure: Daily step count using descriptive statistics Time: 1 year