Erlotinib Intercalated With Chemotherapy Versus Erlotinib as First Line Treatment in Stage IIIB/IV NSCLC Patients With EGFR Mutation

Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Randomized, Open-label Phase III Study of First-line Treatment With Erlotinib Intercalated With Gemcitabine/ Cisplatin or Carboplatin Therapy Versus Erlotinib in Stage IIIB/IV NSCLC Patients With EGFR Mutation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02001896
• Other study ID #: XJTHLC001
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 21, 2013
• Last updated: November 28, 2013
• Start date: December 2013
• Est. completion date: June 2015

Study information

• Verified date: November 2013
• Source: Xinjiang Medical University
• Contact: Li Shan, Master
• Phone: 13609989394
• Email: shanlinew319[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This 2 arm study will compare the efficacy and safety of treatment with erlotinib intercalated with platinum-based therapy or erlotinib along, as first line treatment in Stage IIIB/IV Non-Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation. Patients will be randomized to receive gemcitabine (1000mg/m2 iv) on days 1 , and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by erlotinib 150mg/day from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by erlotinib monotherapy, or erlotinib 150mg/day .The anticipated time on study treatment is until disease progression, and the target sample size is 60 individuals.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;advanced (stage IIIB/IV)non-small cell lung cancer;measurable disease;ECOG Performance Status 0-2.

Exclusion Criteria:

• prior exposure to agents directed at the HER axis;prior chemotherapy or systemic anti-tumor therapy after advanced disease;unstable systemic disease; any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Drug:
• gemcitabine; cisplatin or carboplatin; erlotinib

• erlotinib

Locations

Country	Name	City	State
China	Xinjiang medical university	Urumqi	Xinjiang

Sponsors (1)

Lead Sponsor	Collaborator
Xinjiang Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months	No
Secondary	Overall Survival		From date of randomization until the date of death from any cause, assessed up to 24 mont	No