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

NCT01487174 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-05-13

No results posted yet for this study

Summary

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.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

KD019

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

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.

Sponsors & Collaborators

  • Kadmon Corporation, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-14
Primary Completion
2013-07-25
Completion
2013-07-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01487174 on ClinicalTrials.gov