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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 2

Conditions: Drug Therapy; Genes, EGFR; Carcinoma, Non-Small Cell Lung; Neoplasms, Lung

Treatments: Drug: Cisplatin; Drug: Erlotinib; Drug: Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT01131429

PLAGH-TKIs

Details and patient eligibility

About

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 .

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

first-line erlotinib

Experimental group

Description:

erlotinib in first-line treatment and docetaxel/cisplatin in second-line treatment

Treatment:

Drug: Erlotinib

Drug: Docetaxel

Drug: Cisplatin

Drug: Docetaxel

Drug: Cisplatin

Drug: Erlotinib

second-line erlotinib

Active Comparator group

Description:

docetaxel/cisplatin in first-line treatment and erlotinib in second-line treatment

Treatment:

Drug: Erlotinib

Drug: Docetaxel

Drug: Cisplatin

Drug: Docetaxel

Drug: Cisplatin

Drug: Erlotinib