KD019 Versus Erlotinib in Subjects With Stage IIIB/IV Non Small Cell Lung Cancer With Progression After First- or Second-Line Chemotherapy

NCT ID: NCT01487174

Last Updated: 2022-05-13

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-14

Study Completion Date

2013-07-25

Brief Summary

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This study involves treatment with KD019 or erlotinib in patients with Non-small cell lung cancer (NSCLC) who have progressed after first- or second- line chemotherapy. It is hypothesized that KD019 can prolong survival compared with erlotinib.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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KD019

KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.

Group Type EXPERIMENTAL

KD019

Intervention Type DRUG

KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.

Erlotinib

Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted.

Group Type ACTIVE_COMPARATOR

Erlotinib

Intervention Type DRUG

Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted.

Interventions

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KD019

KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.

Intervention Type DRUG

Erlotinib

Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted.

Intervention Type DRUG

Other Intervention Names

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XL647 Tarceva

Eligibility Criteria

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Inclusion Criteria

For Eligibility subjects must have:

* failed one or two previous courses of therapy.
* have no active brain metastasis. Treated non-active brain metastasis are acceptable.
* cannot have received an Epidermal Growth Factor Receptors inhibitor (Tarceva \[erlotinib\] or Iressa \[gefitinib\]) in the past.
* has demonstrated progressive disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kadmon Corporation, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yale Cancer Center

New Haven, Connecticut, United States

Site Status

San Juan Oncology Associates

Farmington, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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KD019-301

Identifier Type: -

Identifier Source: org_study_id

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