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


Phase 2
18 Years
N/A
Not Enrolling
Both
Neoplasms, Lung, Carcinoma, Non-Small Cell Lung, Drug Therapy, Genes, EGFR

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Trial Information

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


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) ‚Č• 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

three year

Safety Issue:

No

Principal Investigator

Liang-An Chen, M.D., Ph.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Chinese PLA General Hospital, Beijing, China

Authority:

China: Food and Drug Administration

Study ID:

PLAGH-TKIs

NCT ID:

NCT01131429

Start Date:

June 2010

Completion Date:

June 2015

Related Keywords:

  • Neoplasms, Lung
  • Carcinoma, Non-Small Cell Lung
  • Drug Therapy
  • Genes, EGFR
  • mutation analysis
  • first-line
  • second-line
  • targeted therapy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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