A Chinese Randomized Crossover Study of Erlotinib Versus Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations

Survival Analysis of A Chinese Randomized Crossover Study Comparing Erlotinib to Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations

Objective: the objective of this study in china is to clarify, whether the overall survival is different between previously untreated stage IIIB/IV lung adenocarcinoma with EGFR mutations receiving first-line erlotinib plus second-line docetaxel/cisplatin and those receiving first-line docetaxel/cisplatin plus second-line erlotinib .

Study Overview

• Status: Unknown
• Conditions: Neoplasms, Lung; Carcinoma, Non-Small Cell Lung; Drug Therapy; Genes, EGFR
• Intervention / Treatment: Drug: Erlotinib; Drug: Docetaxel; Drug: Cisplatin; Drug: Docetaxel; Drug: Cisplatin; Drug: Erlotinib

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese Pla General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female patients aged over 18 years
• Histologically proven lung adenocarcinoma
• clinical stage IIIB/IV
• ECOG performance status 0-2
• Had no prior anticancer agent, radiation or surgical therapy for lung adenocarcinoma
• At least one measurable lesion (according to RECIST)
• Provision of written informed consent
• Life expectancy of at least 12 weeks

Exclusion Criteria:

• History of malignant disease.
• Evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
• Expected life expectancy less than 2 months
• As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
• Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x ULN if no demonstrable liver metastases (or >5 x in presence of liver metastases)
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
• Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: first-line erlotinib; erlotinib in first-line treatment and docetaxel/cisplatin in second-line treatment	Drug: Erlotinib; Erlotinib 150 mg/d per os until proven disease progression; Drug: Docetaxel; Docetaxel 75mg/m2 iv day 1 every 3 weeks as second-line treatment; Drug: Cisplatin; cisplatin 75mg/ m2 iv day 1 every 3 weeks as second-line treatment; Drug: Docetaxel; Docetaxel 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most; Drug: Cisplatin; Cisplatin 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most; Drug: Erlotinib; Erlotinib 150 mg/d per os as second-line treatment
Active Comparator: second-line erlotinib; docetaxel/cisplatin in first-line treatment and erlotinib in second-line treatment	Drug: Erlotinib; Erlotinib 150 mg/d per os until proven disease progression; Drug: Docetaxel; Docetaxel 75mg/m2 iv day 1 every 3 weeks as second-line treatment; Drug: Cisplatin; cisplatin 75mg/ m2 iv day 1 every 3 weeks as second-line treatment; Drug: Docetaxel; Docetaxel 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most; Drug: Cisplatin; Cisplatin 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most; Drug: Erlotinib; Erlotinib 150 mg/d per os as second-line treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	three year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life during the first-line therapy		every 3 weeks during first-line therapy
progression-free survival during the first-line treatment		1 year
progression-free time during the second-line treatment		2 years
quality of life during the second-line therapy		every 3 weeks during the second-line therapy
response rates during the first-line treatment		at 6 months from treatment initiation
response rates during the second-line treatment		every 3 weeks during the treament, and and every 6 weeks thereafter
toxicity during the first-line treatment		at 12 months from treatment initiation
toxicity during the second-line treatment		end of study
preditive and prognostic markers for chemotherapy or erlotinib	tissues for markers analysis are acquired during diagnosis procedure with informed consent.	end of study

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Study Chair: Liang-An Chen, M.D., Ph.D., Chinese PLA general hospital, Beijing, China

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: May 25, 2010
• First Submitted That Met QC Criteria: May 26, 2010
• First Posted (Estimate): May 27, 2010

Study Record Updates

• Last Update Posted (Estimate): May 27, 2010
• Last Update Submitted That Met QC Criteria: May 26, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: targeted therapy; first-line; second-line; mutation analysis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Adenocarcinoma of Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Protein Kinase Inhibitors; Docetaxel; Erlotinib Hydrochloride; Cisplatin
• Other Study ID Numbers: PLAGH-TKIs