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

Phase 3

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: gemcitabine; cisplatin or carboplatin; erlotinib; Drug: erlotinib

• Registration Number: NCT02001896
• Lead Sponsor: Xinjiang Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-11
• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-11-28
• Last Update Submitted: 2013-11-28
• Study Start: 2013-12
• Study First Posted: 2013-12-05
• Last Update Posted: 2013-12-05
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
erlotinib combine with chemotherapy	gemcitabine; cisplatin or carboplatin; erlotinib	Drug: gemcitabine 1000mg/m2 iv on days 1 of each 4 week cycle for 6 cycles Drug: Platinum chemotherapy (cisplatin or carboplatin) cisplatin --75mg/m2 oon day 1 of each 4 week cycle for 6 cycles or carboplatin--5xAUC on day 1 of each 4 week cycle for 6 cycles Drug: Erlotinib\[Tarceva\] po on days 15-28 of each 4 week cycle until disease progression
erlotinib along	erlotinib	Drug: erlotinib \[Tarceva\] 150mg/day po until disease progression

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Overall Survival	From date of randomization until the date of death from any cause, assessed up to 24 mont

Trial Locations

Locations (1)

Xinjiang medical university; 🇨🇳 Urumqi, Xinjiang, China