Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Study drug: AZD3759 Strength: 50mg/tablet, 100mg/tablet Dose escalation:A treatment cycle consists of consecutive 21 days of dosing. two dose cohorts are planned for dose escalation, including: 150 and 250 mg twice daily.

RP2D in dose expansion.

Strength: 50mg/tablet, 100mg/tablet Dosage and administration: Twice daily administration under fasting state.

AZD3759

Yilong Wu, Professor

This is a multi-center, open-label, dose escalation and phase I/II study, consisting of dose escalation in Part A and phase II study in Part B.

Dose escalation and dose expansion to determine safety and tolerability of AZD3759, and explore RP2D in treatment of Chinese patients with EGFRm+ NSCLC with CNS metastasis. Two dose cohorts include: 150 and 250mg twice daily. Subjects will receive multiple doses of AZD3759 for consecutively 21 days each cycle. Dose escalation is planned to be performed in a single center, and dose expansion in multiple centers.

This is a multi-center, open-label, dose escalation and phase II study, consisting of dose escalation study in Part A and phase II study in Part B.

Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD3759

A Phase I/II, Open-label, Multi-center Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD3759 in Chinese Patients With EGFRm+ NSCLC With Central Nervous System (CNS) Metastases

There is not a plan to make IPD available.

AE.SAE,vital signs, physical examination,laboratory examinations etc.

ORR, DCR, DOR, PFS and tumor size changing compared with baseline according to RECIST 1.1

Area under the plasma concentration versus time curve (AUC)

Tigermed Consulting Co., Ltd

LYZZ Alpha Holding Ltd

Nervous System Diseases

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Erlotinib Hydrochloride

Gefitinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

AZD3759 group will receive a 200 mg twice daily dose of AZD3759

SoC EGFR-TKI Erlotinib or Gefitinib Group will get EGFRTKI Erlotinib 150 mg or Gefitinib 250 mg PO Q.D

Erlotinib

Yilong Wu, M.D.

Myung-Ju Ahn, M.D.

Jie Wang, M.D.

Qing Zhou, M.D.

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 EGFR mutation positive non-small cell lung cancer (NSCLC) with Central Nervous System (CNS) metastasis

This is a Phase II/III randomized, open-label, multicenter study to compare the efficacy and safety of first line single-agent AZD3759 vs. Erlotinib or Gefitinib treatment in patients with advanced EGFR mutation positive NSCLC with CNS metastases.

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

First Line Treatment in EGFR Mutation Positive Advanced NSCLC Patients With Central Nervous System (CNS) Metastases

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

explore the correlation in exposure and efficacy, exposure and safety in the Study

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.

Investigator assessment of PFS using RECIST 1.1

Intracranial PFS (iPFS) assessed by investigator using RECIST 1.1

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

Extracranial PFS (ePFS) assessed by investigator using RECIST 1.1

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

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

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

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

Overall ORR assessed by investigator using RECIST 1.1

Overall DCR assessed by investigator using RECIST 1.1

Overall DoR assessed by investigator using RECIST 1.1

ORR for Intracranial lesions assessed by investigator using RANO-BM

DCR for Intracranial lesions assessed by investigator using RANO-BM

DoR for Intracranial lesions assessed by investigator using RANO-BM

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.

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.

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

Neurological function improvement rate assessed by RANO-BM criteria

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

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

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

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

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

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

Systolic and Diastolic Blood Pressure assessed during the study period.

Pulse rate to assessed during the study period.

Body temperature assessed during the study period.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD3759	NCT03360929	Non Small Cell ...	AZD3759	18 Years -	LYZZ Alpha Holding Ltd
First Line Treatment in EGFR Mutation Positive Advanced NSCLC Patients With Central Nervous System (CNS) Metastases	NCT03653546	Non-small Cell ... EGFR Gene Mutat... Brain Metastase...	AZD3759 Erlotinib Gefitinib	18 Years -	Alpha Biopharma (Jiangsu) Co., Ltd.
First Line Treatment in EGFR Mutation Positive Advanced NSCLC Patients With Central Nervous System (CNS) Metastases	NCT03653546	Non-small Cell ... EGFR Gene Mutat... Brain Metastase...	AZD3759 Erlotinib Gefitinib	18 Years -	Alpha Biopharma (Jiangsu) Co., Ltd.
Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD3759	NCT03360929	Non Small Cell ...	AZD3759	18 Years -	LYZZ Alpha Holding Ltd

Spots Global Cancer Trial Database for azd3759

Every month we try and update this database with for azd3759 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for azd3759

Every month we try and update this database with for azd3759 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for azd3759 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.