SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT03653546

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized, Open-label, Controlled, Multi-Center Phase II/III Study to Assess the Efficacy and Safety of AZD3759 vs. a Standard of Care EGFR TKI, as First Line Treatment to EGFR Mutation Positive Advanced NSCLC With CNS Metastases

Primary Hypothesis The first-line treatment with single agent AZD3759 results in superior Progression Free Survival (PFS) compared to Standard of Care (SoC) Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKI), in patients with advanced Non-Small Cell Lung Cancer (NSCLC) with Central Nervous System (CNS) metastasis Secondary Hypothesis The safety profile of AZD3759 is comparable to EGFR TKI first-line treatment in patients with advanced NSCLC with CNS metastasis.

NCT03653546 Non-small Cell Lung Cancer EGFR Gene Mutation Brain Metastases
MeSH:Neoplasm Metastasis Neoplasms, Second Primary

3 Interventions

Name: AZD3759

Description: Advanced Non-Small Cell Lung Cancer (NSCLC) with CNS metastases.
Type: Drug
Group Labels: 1

AZD3759 Group

Name: Erlotinib

Description: SoC EGFRTKI Erlotinib 150 mg PO Q.D
Type: Drug
Group Labels: 1

Erlotinib or Gefitinib Group

Name: Gefitinib

Description: SoC EGFRTKI Gefitinib 250 mg PO Q.D
Type: Drug
Group Labels: 1

Erlotinib or Gefitinib Group


Primary Outcomes

Description: To assess if first line treatment with AZD3759 results in significant PFS efficacy compared to Gefitinib or Erlotinib as determined by Blinded Independent Central Radiological (BICR) review using RECIST 1.1.

Measure: PFS assessed by Blinded Independent Central Radiological

Time: 36 months

Secondary Outcomes

Description: Investigator assessment of PFS using RECIST 1.1

Measure: PFS assess by investigator

Time: 36 months

Description: Intracranial PFS (iPFS) assessed by investigator using RECIST 1.1

Measure: Intracranial PFS (iPFS) assessed by investigator

Time: 36 months

Description: Intracranial PFS (iPFS) assessed by Blinded Independent Central Radiological (BICR) using RECIST 1.1

Measure: Intracranial PFS (iPFS) assessed by BICR

Time: 36 months

Description: Extracranial PFS (ePFS) assessed by investigator using RECIST 1.1

Measure: Extracranial PFS (ePFS) assessed by investigator

Time: 36 months

Description: Extracranial PFS (ePFS) assessed by Blinded Independent Central Radiological (BICR) using RECIST 1.1

Measure: Extracranial PFS (ePFS) assessed by BICR

Time: 36 months

Description: Objective Response Rate (ORR) for Intracranial lesions and Extracranial lesions assessed separately by investigator using RECIST 1.1

Measure: Objective Response Rate (ORR) assessed by investigator using RECIST 1.1

Time: 36 months

Description: Disease Control Rate (DCR) for Intracranial lesions and Extracranial lesions assessed separately by investigator using RECIST 1.1

Measure: Disease Control Rate (DCR) assessed by investigator using RECIST 1.1

Time: 36 months

Description: Duration of Response (DoR) for Intracranial lesions and Extracranial lesions assessed separately by investigator using RECIST 1.1

Measure: Duration of Response (DoR) assessed by investigator using RECIST 1.1

Time: 36 months

Description: Overall ORR assessed by investigator using RECIST 1.1

Measure: Overall ORR assessed by investigator using RECIST 1.1

Time: 36 months

Description: Overall DCR assessed by investigator using RECIST 1.1

Measure: Overall DCR assessed by investigator using RECIST 1.1

Time: 36 months

Description: Overall DoR assessed by investigator using RECIST 1.1

Measure: Overall DoR assessed by investigator using RECIST 1.1

Time: 36 months

Description: ORR for Intracranial lesions assessed by investigator using RANO-BM

Measure: ORR for Intracranial lesions assessed by investigator using RANO-BM

Time: 36 months

Description: DCR for Intracranial lesions assessed by investigator using RANO-BM

Measure: DCR for Intracranial lesions assessed by investigator using RANO-BM

Time: 36 months

Description: DoR for Intracranial lesions assessed by investigator using RANO-BM

Measure: DoR for Intracranial lesions assessed by investigator using RANO-BM

Time: 36 months

Description: Overall Survival

Measure: Overall Survival

Time: 36 months

Description: The 30-items questionnaire measures cancer patients' functioning and symptoms. The scale range of EORTC QLQ-C30 is 30-126. Lower values represent a better outcome.

Measure: Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30).

Time: 36 months

Description: The 20-items questionnaire was used among brain cancer patients. The scale range of EORTC BN20 is 20-80. Lower values represent a better outcome.

Measure: Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire BN20 (EORTC QLQ-BN20).

Time: 36 months

Description: Neurological function improvement rate assessed by Mini-Mental Status Examination (MMSE)

Measure: Neurological function improvement rate assessed by Mini-Mental Status Examination (MMSE)

Time: 36 months

Description: Neurological function improvement rate assessed by RANO-BM criteria

Measure: Neurological function improvement rate assessed by RANO-BM criteria

Time: 36 months

Description: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Measure: Number of participants with treatment-related Adverse Events as assessed by CTCAE v5.0

Time: 36 months

Description: Number of participants with treatment-related Serious Adverse Events as assessed by CTCAE v5.0

Measure: Number of participants with treatment-related Serious Adverse Events as assessed by CTCAE v5.0

Time: 36 months

Description: Incidence of laboratory abnormalities collected by hematology tests during the study as assessed by CTCAE v5.0

Measure: Incidence of laboratory abnormalities collected by hematology tests during the study as assessed by CTCAE v5.0

Time: 36 months

Description: Incidence of laboratory abnormalities collected by biochemistry tests during the study as assessed by CTCAE v5.0

Measure: Incidence of laboratory abnormalities collected by biochemistry tests during the study as assessed by CTCAE v5.0

Time: 36 months

Description: Incidence of laboratory abnormalities collected byurinalysis tests during the study as assessed by CTCAE v5.0

Measure: Incidence of laboratory abnormalities collected byurinalysis tests during the study as assessed by CTCAE v5.0

Time: 36 months

Description: Rhythm, PR, R-R, QRS and QT intervals and an overall evaluation of ECG assessed during the study period.

Measure: Rhythm, PR, R-R, QRS and QT intervals and an overall evaluation of ECG assessed during the study period.

Time: 36 months

Description: Systolic and Diastolic Blood Pressure assessed during the study period.

Measure: Systolic and Diastolic Blood Pressure assessed during the study period.

Time: 36 months

Description: Pulse rate to assessed during the study period.

Measure: Pulse rate assessed during the study period.

Time: 36 months

Description: Body temperature assessed during the study period.

Measure: Body temperature assessed during the study period.

Time: 36 months

Description: Blinded Independent Central Radiological (BICR) assessment of PFS using modified RECIST 1.1.

Measure: PFS assess by BICR

Time: 36 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

Blinded Independent Central Radiological (BICR) assessment of PFS using modified RECIST 1.1.. Inclusion Criteria: 1. Properly completed patient informed consent 2. Male or female aged at least 18 years 3. Histologically or cytologically confirmed diagnosis of NSCLC with activating EGFR mutations including L858R and/or Exon19Del. --- L858R ---

Inclusion Criteria: 1. Properly completed patient informed consent 2. Male or female aged at least 18 years 3. Histologically or cytologically confirmed diagnosis of NSCLC with activating EGFR mutations including L858R and/or Exon19Del. --- L858R ---

Eligible patients with documented EGFR mutation+ (L858R and/or Exon 19Del) TKI-naïve advanced NSCLC and documented intracranial disease will be enrolled. --- L858R ---



HPO Nodes