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

NCT ID: NCT02001896

Last Updated: 2013-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Non-Small Cell Lung Cancer

Keywords

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NSCLC EGFR-TKI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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erlotinib combine with chemotherapy

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

Group Type EXPERIMENTAL

gemcitabine; cisplatin or carboplatin; erlotinib

Intervention Type DRUG

erlotinib along

Drug: erlotinib \[Tarceva\] 150mg/day po until disease progression

Group Type ACTIVE_COMPARATOR

erlotinib

Intervention Type DRUG

Interventions

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gemcitabine; cisplatin or carboplatin; erlotinib

Intervention Type DRUG

erlotinib

Intervention Type DRUG

Other Intervention Names

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tarceva tarceva

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinjiang Medical University

OTHER

Sponsor Role lead

Responsible Party

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li shan

chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xinjiang medical university

Ürümqi, Xinjiang, China

Site Status

Countries

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China

Central Contacts

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Li Shan, Master

Role: CONTACT

Phone: 13609989394

Email: [email protected]

Qiang Wang, Master

Role: CONTACT

Phone: 13579960434

Facility Contacts

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Li Shan, Master

Role: primary

Other Identifiers

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XJTHLC001

Identifier Type: -

Identifier Source: org_study_id