Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Bevacizumab 15 mg/kg shall be intravenous infusion on day 1 once every 3 weeks, Icotinib 250 mg tablets shall be administered orally 3 times every day at least one hour before or two hours after the ingestion of food.

Bevacizumab15mg/kg by intravenous drip infusion on day 1 of a 21-day (within 3 days) cycle; Icotinib orally twice daily at 250mg/day

Bevacizumab and Icotinib

zhansheng jiang, doctor

zhanyu pan, doctor

Zhanyu Pan, Master

dongyan cheng, doctor

This is a one-arm, observational, phase 2 clinical study . Patients with EGFR L858R mutation will be assigned to treatment group.The study includes the following stratification factors : sex (female/male), disease stage (stage IIIb vs. stage IV), and brain metastasis (yes vs. no).

This is a one-arm, observational, phase 2 clinical study . Patients with EGFR L858R mutation will be assigned to treatment group.The study includes the following stratification factors : sex (female/male), disease stage (stage IIIb vs. stage IV), and brain metastasis (yes vs. no).

An independent review committee (IRC) will be used to determine the response based study endpoints. IRC membership and procedures will be detailed in an IRC charter.

A data safety monitoring board (DSMB) will be used in this study. DSMB is an independent body and will be responsible for reviewing safety data of the study. DSMB membership and procedures will be detailed in a separate DSMB document.

Information regarding the nature and the duration of subsequent treatment will be collected.

This is a treatment group. Patients with EGFR L858R mutation will be assigned to treatment group.The study includes the following stratification factors : sex (female/male), disease stage (stage IIIb vs. stage IV), and brain metastasis (yes vs. no).

Bevacizumab Combined With Double Dose Icotinib in Patients With EGFR Exon 21-L858R Mutation

A One-arm, Observational, Phase 2 Clinical Study of Bevacizumab Combined With Double Dose Icotinib in Patients With EGFR Exon 21-L858R Mutant Advanced Non-squamous Non-small Cell Lung Cancer

The time from enrolment until an investigator-documented progression of disease according to RECIST 1.1 or death if no documented progression occurred.

The time from enrolment until death from any cause.

Complete response or partial response according to RECIST 1.1 criteria

Tianjin Medical University Cancer Institute and Hospital

Symptoms and General Pathology

Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

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

AZD3759

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
Bevacizumab Combined With Double Dose Icotinib in Patients With EGFR Exon 21-L858R Mutation	NCT05263947	Carcinoma, Non-... Bevacizumab EGF-R Positive ... Tyrosine Kinase...	Bevacizumab and...	18 Years - 75 Years	Tianjin Medical University Cancer Institute and Hospital
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.

Spots Global Cancer Trial Database for l858r

Every month we try and update this database with for l858r 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 l858r

Every month we try and update this database with for l858r 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 l858r 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.