Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Erlotinib Hydrochloride

Gefitinib

Nazartinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Investigational treatment arm of EGF816 (nazartinib).

Investigator's Choice (erlotinib or gefitinib).

EFG816

Investigator's choice between erlotinib or gefitinib. These will be locally sourced.

Erlotinib will be administered orally daily. Gefitinib will be administered orally daily.

erlotinib or gefitinib

Novartis Pharmaceuticals

This is a phase III, open label, randomized controlled multi-center global study designed to evaluate the safety and efficacy of single agent nazartinib (EGF816) compared with investigator's choice (erlotinib or gefitinib) in patients with locally advanced or metastatic NSCLC who are treatment naïve and whose tumors harbor EGFR activating mutations (L858R or ex19del).

blinded independent review committee for primary endpoint of PFS

Phase III Study of Nazartinib (EGF816) Versus Erlotinib/Gefitinib in First-line Locally Advanced / Metastatic NSCLC With EGFR Activating Mutations

A Randomized, Open-label, Phase III Study of Single Agent Nazartinib Versus Investigator's Choice (Erlotinib or Gefitinib) as First-Line Treatment in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Activating Mutations

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

PFS using central BIRC assessment according to RECIST 1.1, is defined as the time from the date of randomization to the date of the first documented progression (as assessed by BIRC per RECIST 1.1) or death due to any cause, whichever occurs first.

Overall survival is defined as the time from date of randomization to date of death due to any cause.

PFS by Investigator assessment according to RECIST 1.1, is defined as the time from the date of randomization to the date of the first documented progression (as assessed by Investigator per RECIST 1.1) or death due to any cause, whichever occurs first.

PFS after next-line of treatment (PFS2) using investigator assessment according to RECIST 1.1 is defined as time from date of randomization to the first documented disease progression (clinical or radiologic) as per investigator assessment on next-line therapy or death from any cause, whichever occurs first.

Time to progression in CNS, defined as time from date of randomization to the date of first documented progression of brain metastases as assessed by central neuro-radiologist BIRC per modified RECIST 1.1 for patients with at least one non-measurable and/or measurable lesion in the brain at baseline.

ORR in accordance with RECIST 1.1. ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR)

DOR is defined as the time from date of first documented response (CR and PR) to the date of the first documented progression or death due to underlying cancer, whichever occurs first.

DCR is defined as the percentage of participants with BOR of CR, PR, or stable disease (SD).

TTR is defined as the time from the date of randomization to the first documented response CR or PR.

CNS ORR in patients with brain metastases who have measurable disease in the brain at baseline review per modified RECIST 1.1

CNS DoR in patients with brain metastases who have measurable disease in the brain at baseline per modified RECIST 1.1

Peak plasma concentration (Cmax) of EGF816 and its metabolite (LMI258)

Area under the plasma concentration versus time curve (AUC) of EGF816 and its metabolite (LMI258)

Elimination half life (t1/2) of EGF816 and its metabolite (LMI258)

HRQoL as measured by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 quality of life score

HRQoL as measured by European Organization for Research and Treatment of Cancer (EORTC) QLQ-LC13 quality of life score

Global health status/quality of life score of the EQ-5D-5L

Substance Related Disorders

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Patients received the treatment with high-dose, pulsatile Erlotinib(600 mg every 4 days) or Gefitinib (1000 mg every 4 days) until disease progression or unacceptable toxicity occurred. The overall study period takes about 12 months

Erlotinib or Gefitinib

Yanzhe Zhu, MD

Yueyin Pan, MD

Yueyin Pan, PHD,MD

the purpose of this study is to evaluate the efficacy and safety of high-dose，pulsatile Erlotinib/Gefitinib in advanced non small cell lung cancer (NSCLC) patients after failure of standard dose EGFR-TKIs（Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors）

To evaluate the efficacy and safety by treating the advanced non small cell lung cancer (NSCLC) patients who have failure of standard dose EGFR-TKIs(Erlotinib or Gefitinib ) with high-dose, pulsatile Erlotinib(450mg every 3 days) or Gefitinib (1000mg every 4 days)

High-Dose,Pulsatile Erlotinib/Gefitinib for Advanced NSCLC Patients After Failure of Standard Dose EGFR-TKIs

An Open,Multi Center Trial to Evaluate the Efficacy and Safety of High-Dose,Pulsatile Erlotinib/Gefitinib for Advanced Non-Small Cell Lung Cancer Patients After Failure of Standard Dose EGFR-TKIs

To evaluate the efficacy and safety by treating the advanced NSCLC patients who have failure of standard dose EGFR-TKIs with high-dose, pulsatile Erlotinib(600mg every 4 days) or Gefitinib (1000mg every 4 days)

Radiologically measurable disease by RECIST v1.1 criteria:

1. At least one target lesion that has not previously been radiated and is measurable according to RECIST v1.1;
2. Acceptable radiologic procedures for disease assessment include contrast enhanced conventional or spiral computed tomography (CT), or contrast enhanced magnetic resonance imaging (MRI); Non-contrast CT scan is acceptable only for subjects who are both allergic to intravenous contrast and unable to cooperate with MRI, or MRI is not available. The following are not allowed as sole documentation of target lesions: CT component of a positron emission tomography (PET)/CT,ultrasound alone, nuclear scans (including bone or PET scans), chest X-ray or bone radiographs, and tumor markers

Anhui Medical University

Professor

Digestive System Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Anti-Infective Agents

Everolimus

Sunitinib

Sorafenib

Imatinib Mesylate

Sirolimus

Temsirolimus

MTOR Inhibitors

Immunosuppressive Agents

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Erlotinib 150 mg tablet or Gefitinib 250 mg tablet by mouth every day

Everolimus 10 mg orally once daily every day

Sorafenib 400 mg twice a day at least one hour before or two hours after eating or Sunitinib 50 mg orally once a day

No intervention was performed for patients without any gene alternation or without any available target agents

Erlotinib 150mg talbet or Gefitinib 250 mg tablet per day for patients with EGFR gene alternation

Everolimus 10 mg orally once daily every day for patients with mTOR gene alternation

Imatinib 400 mg tablet orally per day for patietns with KIT, PDGFR, ABL gene alternation

Imatinib

Sorafenib 400 mg twice a day at least one hour before or two hours after eating or Sunitinib 50 mg orally once a day with or without food for patients with VEGFR, KIT, RAF gene alternation

Sorafenib or Sunitinib

Vandetanib 300 mg orally once daily for patients with RET gene fusion.

Vandetanib

Yanghong Deng, PhD

Yanhong Deng, PhD

Hypothesis: Different patients have different biomarkers, if doctors know about the biomarkers of patients; they may be able to prescribe a regimen that is better suited to the patient's specific needs. This is a pilot study. Here, we used whole exon sequencing and Integrated genomic network analysis to identify the biomarker or gene. We aimed to learn if the drug chosen based on biomarkers can help to control metastatic gastrointestinal cancer who had failed from all standard and available regimens.

Rational: Cancer sequencing (CS) promises to become the centerpiece of personalized oncology by informing on treatments targeted to each tumor's unique genetic constitution. This data can be critical to making an informed decision for disease management, though this may not be the case for all patients. CS identifies variations or differences in the DNA and/or RNA of the cells in an individual's tumor by comparison to that of his/her normal cells. These somatic variations may, on further interpretation, be identified as key drivers of carcinogenesis. Such information may predict a patient's prognosis, response to currently available treatments or prompt the development of novel therapeutics. Though CS has the potential to personalize and optimize cancer care, it may produce a vast amount of data and unique changes in the DNA/RNA that may be difficult to interpret at the present time.

Using the Integrated genomic network analysis, we could have better understanding of the underlying processes and pathways involved in tumor onset and progression. And then we could choose a specific treatment regimen and develop personalized cancer therapies

A Pilot Study of Genomic Sequencing Guided Individualized Therapy in Gastrointestinal Cancers, GITIC Study

A Pilot Study of Genomic Sequencing Guided Individualized Therapy in Gastrointestinal Cancers

The disease control rate of all patients.

From the date of enrollment until the date of death from any cause.

After identifying the driver gene and choosing the specific target drug, the response rate of all patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase III Study of Nazartinib (EGF816) Versus Erlotinib/Gefitinib in First-line Locally Advanced / Metastatic NSCLC With EGFR Activating Mutations	NCT03529084	Carcinoma, Non-...	EFG816 erlotinib or ge...	18 Years -	Novartis
High-Dose,Pulsatile Erlotinib/Gefitinib for Advanced NSCLC Patients After Failure of Standard Dose EGFR-TKIs	NCT01965275	Self Efficacy Drug Toxicity	Erlotinib or Ge...	18 Years - 75 Years	Anhui Medical University
High-Dose,Pulsatile Erlotinib/Gefitinib for Advanced NSCLC Patients After Failure of Standard Dose EGFR-TKIs	NCT01965275	Self Efficacy Drug Toxicity	Erlotinib or Ge...	18 Years - 75 Years	Anhui Medical University
A Pilot Study of Genomic Sequencing Guided Individualized Therapy in Gastrointestinal Cancers, GITIC Study	NCT02013089	Gastrointestina...	Erlotinib or Ge... Everolimus Imatinib Sorafenib or Su... Vandetanib	18 Years - 70 Years	Sun Yat-sen University
A Pilot Study of Genomic Sequencing Guided Individualized Therapy in Gastrointestinal Cancers, GITIC Study	NCT02013089	Gastrointestina...	Erlotinib or Ge... Everolimus Imatinib Sorafenib or Su... Vandetanib	18 Years - 70 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for erlotinib or gefitinib