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

Phase 3

Terminated

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: KD019; Drug: Erlotinib

• Registration Number: NCT01487174
• Lead Sponsor: Kadmon Corporation, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-02
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-07
• Study Start: 2011-12-14
• Primary Completion: 2013-07-25
• Study Completion: 2013-07-25
• Disposition First Submitted: 2014-07-21
• Disposition First Submitted QC: 2014-07-21
• Disposition First Posted: 2014-07-24
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KD019	KD019	KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
Erlotinib	Erlotinib	Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted.

Primary Outcome Measures

Name	Time	Method
Overall survival	Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
Number and type of adverse events related to KD019	Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year	For the purpose of data collection, all untoward events that occur after informed consent through 30 days after last dose of study treatment are to be recorded.
Objective response rate	Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year

Trial Locations

Locations (2)

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

San Juan Oncology Associates; 🇺🇸 Farmington, New Mexico, United States