Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Disease Progression

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Amino Acids

Pemetrexed

Cisplatin

Mitogens

Gefitinib

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Folinic Acid

Folate

Vitamin B9

Tyrosine

Gefitinib and cisplatin plus pemetrexed combination chemotherapy

Placebo and cisplatin plus pemetrexed combination chemotherapy.

Placebo

Yuri Rukazenkov, MD PhD, GCL Oncology

Tony Mok, M.D.

Jean-Charles Soria, MD, PHD

Haiyi Jiang, M.D. MSc

The purpose of this study is to assess the efficacy and safety of gefitinib in patients who have progressed on first line gefitinib, comparing continuing gefitinib in addition to cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed combination chemotherapy alone.

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.

A Study of IRESSA Treatment Beyond Progression in Addition to Chemotherapy Versus Chemotherapy Alone

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

PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.

OS is the time from the date of randomisation until death due to any cause. Any subject not known to have died at the time of analysis will be censored based on the last recorded date on which the subject was known to be alive.

ORR rate is defined as the number (%) of subjects with at least one visit response of Complete Response (CR) or Partial Response (PR) , as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions. Data obtained up until progression, or last evaluable assessment in the absence of progression, was included in the assessment of ORR.

DCR is the percentage of patients who achieve disease control at 6 weeks following randomisation. DCR is defined as a Best Objective Response (BOR) of Complete Response, Partial Response or Stable Disease, as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions; SD, neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for Progressive Disease (PD); PD, ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and the sum must have shown an absolute increase of ≥5mm

An improvement is defined as a change from baseline of ≥ +6 (0-84 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire.

A worsening is defined as a change from baseline of ≤ -6 (0-84 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire

An improvement is defined as a change from baseline of ≥ +6 (0-136 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire

A worsening is defined as a change from baseline of ≤ -6 (0-136 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire

An improvement is defined as a change from baseline of ≥ +2 (0-28 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire

A worsening is defined as a change from baseline of ≤ -2 (0-28 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire

AstraZeneca

Gefitinib 250 mg

Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy

Total

<65 years

>=65 years

Age, Customized

Sex: Female, Male

Asian

Black or African American

White

Race/Ethnicity, Customized

Haiyi Jiang/Asia Medical Director

Progression-Free Survival (Site Read, Investigator Assessment)

Median Progression-Free Survival (Site Read, Investigator Assessment)

Overall Survival (OS)

Median Overall Survival (OS) at Time of PFS Analysis

Objective Response Rate (ORR) (Site Read Data)

Disease Control Rate (DCR)

Improvement in Trial Outcome Index

Time to Worsening in Trial Outcome Index

Improvement in FACT-L Total Score

Time to Worsening in FACT-L Total Score

Improvement in Lung Cancer Subscale

Time to Worsening in Lung Cancer Subscale

Overall Study

Disease Attributes

Paclitaxel

Carboplatin

Docetaxel

Albumin-Bound Paclitaxel

Erlotinib Hydrochloride

Tubulin Modulators

Antimitotic Agents

Intercalated erlotinib in combination with chemotherapy for four to six cycles followed by continuous erlotinib maintenance

Erlotinib

Chemotherapy

The purpose of this study is to determine whether continuing erlotinib beyond disease progression in combination with chemotherapy is beneficial for NSCLC patients who have EGFR mutant disease or who have responded to EGFR TKI.

A Phase II randomised, multicenter study to assess the efficacy and safety of continuing erlotinib in addition to chemotherapy versus chemotherapy alone in patients who have EGFR mutant or EGFR TKI responsive NSCLC and have progressed on EGFR TKI.

Erlotinib Treatment Beyond Progression in EGFR Mutant NSCLC

Erlotinib Treatment Beyond Progression in EGFR Mutant or Patients Who Have Responded EGFR TKI in Stage IIIB/IV NSCLC

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Roche Pharma AG

Finnish Lung Cancer Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of IRESSA Treatment Beyond Progression in Addition to Chemotherapy Versus Chemotherapy Alone	NCT01544179	Non-Small Cell ...	Gefitinib Placebo Pemetrexed Cisplatin	18 Years - 130 Years	AstraZeneca
Erlotinib Treatment Beyond Progression in EGFR Mutant NSCLC	NCT02064491	Non-small Cell ...	Erlotinib Chemotherapy	18 Years -	Finnish Lung Cancer Group

Spots Global Cancer Trial Database for treatment beyond progression