A Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer

NCT ID: NCT01196078

Last Updated: 2015-07-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-12-31

Brief Summary

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This study will compare the efficacy and safety of Tarceva (erlotinib) and vinorelbine in chemo-naive elderly patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg po daily) or vinorelbine (60 mg/m2 on days 1 and 8 of cycle 1 and 80 mg/m2 for the other 21 days cycles). The anticipated time on study treatment is until disease progression.

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

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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1

Group Type EXPERIMENTAL

erlotinib [Tarceva]

Intervention Type DRUG

150 mg, orally once a day for up to 6 cycles of 21 days each

2

Group Type ACTIVE_COMPARATOR

vinorelbine

Intervention Type DRUG

60 mg/m2, orally on days 1 and 8 of cycle 1, 80 mg/m2 for the other cycles

Interventions

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erlotinib [Tarceva]

150 mg, orally once a day for up to 6 cycles of 21 days each

Intervention Type DRUG

vinorelbine

60 mg/m2, orally on days 1 and 8 of cycle 1, 80 mg/m2 for the other cycles

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>=70 years of age
* Non-small cell lung cancer
* Naive to prior chemotherapy or specific immunotherapy
* Presence of at least 1 measurable lesion

Exclusion Criteria

* Active non-controlled infection or disease
* CNS metastases
* Any other malignancies (other than adequately treated basal cell cancer of skin, or in situ cancer of the cervix)
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

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Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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ML20322

Identifier Type: -

Identifier Source: org_study_id

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