Center for Global Research Data

Longitudinal peripheral blood markers as dynamic predictors to identify efficacy and safety of non–small-cell lung cancer (NSCLC) patients treated with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs)

Lead Investigator: Jian-Guo Zhou, The Second Affiliated Hospital of Zunyi Medical University
Title of Proposal Research: Longitudinal peripheral blood markers as dynamic predictors to identify efficacy and safety of non–small-cell lung cancer (NSCLC) patients treated with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs)
Vivli Data Request: 6629
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

In the United States, lung cancer causes more deaths per year (131,880 estimated for 2021) than does any other cancer type, and 84% of lung cancer deaths are caused by non-small cell lung cancer (NSCLC). Treatment options for NSCLC has expanded greatly in the last century. Early in the 20th century, the primary mode of treatment for NSCLC was surgery. Today, we not only have chemotherapy drugs (chemical agents with broad specificity), but also targeted therapy (drugs which precisely target molecules pertinent to tumor growth, and hence, are scarce on normal cells to reduce side effects). For instance, epidermal growth factor receptor (EGFR) is a type of protein found in NSCLC cells which often gets mutated and leads to tumor growth. Tyrosine kinase inhibitors (TKIs) is a type of target therapy developed to specifically prevent the activation of this EGFR protein. Hence, this could effectively treat EGFR-mutant lung cancer.

To date, three generations of TKIs have been approved for the treatment of EGFR-mutant lung cancer. However, patients treated with EGFR-TKIs are likely to acquire resistance and cancer recurrence occurs within 1 year of treatment initiation. Several recent clinical studies indicated that the blood cell counts were significantly related to poor survival in EGFR-mutant NSCLC patients. Therefore, identifying biomarkers from blood will enable real-time disease monitoring to facilitate evaluation of EGFR-TKI therapeutic efficacy. Hence, this study aims to use blood biomarkers as dynamic predictors to monitor treatment outcomes and decide treatment termination. The correlation between blood biomarkers over the course of treatment and treatment outcomes of NSCLC patients with EGFR mutation undergoing EGFR-TKI therapy from shared clinical datasets. The identified predictors will be used to monitor treatment outcomes and decide treatment termination to improve EGFR-TKI treatment outcomes.

Requested Studies:

MERIT – A Phase II Marker Identification Trial for Tarceva in Second Line NSCLC Patients
Data Contributor: Roche
Study ID: NCT02774278
Sponsor ID: BO18279

A Phase III Randomised, Double Blind, Placebo Controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of Continuing IRESSA 250 mg in Addition to Chemotherapy Versus Chemotherapy Alone in Patients Who Have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and Have Progressed on First Line IRESSA
Data Contributor: AstraZeneca
Study ID: NCT01544179
Sponsor ID: D791LC00001

An Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA™) as First Line Treatment in Caucasian Patients, Who Have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Data Contributor: AstraZeneca
Study ID: NCT01203917
Sponsor ID: D791AC00014

A Randomized Ph 3 Study Comparing First-Line Pemetrexed/Cisplatin Followed by Gefitinib With Gefitinib Alone in East Asian Never Smoker or Light Ex-Smoker Patients With Locally Advanced or Metastatic Nonsquamous NSCLC
Data Contributor: Lilly
Study ID: NCT01017874
Sponsor ID: 13021

A Phase 2 Study of Pemetrexed Versus Pemetrexed Plus Erlotinib in Second-Line Treatment in Patients With Nonsquamous NSCLC
Data Contributor: Lilly
Study ID: NCT00447057
Sponsor ID: 10721

A Phase II Multicentre Randomised, Parallel Group, Double-Blind, Placebo-Controlled Study of ZD1839 (IRESSATM) (250MG Tablet) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Chemotherapy-Naive Patients With Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) and Poor Performance Status
Data Contributor: AstraZeneca
Study ID: NCT00259064
Sponsor ID: 1839IL/0711

A Randomised, Open Label, Parallel Group, Multi-Centre, Phase II Study of Progression Free Survival Comparing ZD1839 (IRESSA™) (250 MG Tablet) Versus Vinorelbine (30 MG/M2 Infusion) in Chemonaive, Elderly Patients With Locally Advanced (Stage IIIB) or Metastatic (Stage IV) NSCLC
Data Contributor: AstraZeneca
Study ID: NCT00256711
Sponsor ID: D791AC00001

A Nested Case-control Study to Determine the Relative Risk of and Risk Factors for Interstitial Lung Disease in a Cohort of NSCLC Patients Treated With and Without Gefitinib
Data Contributor: AstraZeneca
Study ID: NCT00252759
Sponsor ID: D791AL00002

A Double Blind,Placebo Controlled,Parallel Group,Multicentre,Randomised,Phase Iii Survival Study Comparing ZD1839 (IRESSA™)(250mg Tablet) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients With Advanced NSCLC Who Have Received One Or Two Prior Chemotherapy Regimens And Are Refractory Or Intolerant To Their Most Recent Regimen
Data Contributor: AstraZeneca
Study ID: NCT00242801
Sponsor ID: 1839IL/0709

A Phase III, Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva (Erlotinib) Compared With Tarceva Alone for Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) After Failure of Standard First-Line Chemotherapy
Data Contributor: Roche
Study ID: NCT00130728
Sponsor ID: OSI3364g

An Expanded Access Clinical Program With ZD1839 (IRESSA®) for Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Data Contributor: AstraZeneca
Study ID: NCT00034879
Sponsor ID: 1839IL/0050

A Randomised, Double Blind, Parallel Group, Phase II, Multicentre Study to Assess the Efficacy of ZD1839 (Iressa) 250 & 500mg/day in Patients with Advanced Non-Small Cell Lung Cancer who have failed one or two previous Chemotherapy Regimens; at least one having contained Platinum.
Data Contributor: AstraZeneca
Study ID: D7913C00016
Sponsor ID: D7913C00016

A Randomised, Double Blind, Phase III Comparative Trial Of 2 Doses Of ZD1839 (Iressa) In Combination With Paclitaxel And Carboplatin Versus Placebo In Combination With Paclitaxel and Carboplatin in Chemotherapy-Naive Patients With Advanced (stage III of IV) Non-Small Cell Lung Cancer.
Data Contributor: AstraZeneca
Study ID: D7913C00017
Sponsor ID: D7913C00017

A Randomized, Double Blind, Parallel Group, Phase II/III, Multi-center Trial of Two Doses of ZD1839 (IressaTM) in Patients with Advanced NSCLC Who Have Failed at Least Two Previous Chemotherapy Regimens At Least One or Both Having Contained Platinum and a Taxane.
Data Contributor: AstraZeneca
Study ID: D7913C00039
Sponsor ID: D7913C00039

A Randomized, Open Label, Parallel Group, Regional, Multicenter, Phase III Study of Oral Gefitinib (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non Small Cell Lung Cancer Who Have Previously Received Platinum Based Chemotherapy (ISTANA)
Data Contributor: AstraZeneca
Study ID: NCT00478049
Sponsor ID: D7913L00039

A Phase II Open-label, randomised, parallel group, non comparative study of ZD1839 (IressaTM) and Docetaxel (Taxotere) as second line therapy in subjects with advanced (Stage IIIB or IV) non-small cell lung cancer.
Data Contributor: AstraZeneca
Study ID: D791AC00009
Sponsor ID: D791AC00009

An open phase II study of ZD1839 (Iressa) plus best supportive care (BSC) in chemotherapy-naiive patients ineligible for chemotherapy with advanced (stage IIIB or IV) non-small cell lung cancer
Data Contributor: AstraZeneca
Study ID: D7913C00120
Sponsor ID: D7913C00120

Multicentre randomised phase II study of ZD1839 plus gemcitabine and ZD1839 plus vinorelbine as first line therapy for elderly advanced NSCLC patients
Data Contributor: AstraZeneca
Study ID: D7913C00072
Sponsor ID: D7913C00072

An open label, pilot trial of two doses of ZD1839 (IRESSA) in combination with docetaxel in patients with advanced or metastatic non-small cell lung cancer (NSCLC)
Data Contributor: AstraZeneca
Study ID: D7913C00054
Sponsor ID: D7913C00054

A Randomised, Double-Blind, Phase III, Comparative Trial Of 2 Doses Of ZD1839 (Iressa) In Combination With Gemcitabine and Cisplatin Versus Placebo In Combination With Gemcitabine And Cisplatin In Chemotherapy-Naive Patients With Advanced (Stage III or IV) Non-Small Cell Lung Cancer.
Data Contributor: AstraZeneca
Study ID: D7913C00014
Sponsor ID: D7913C00014