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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

A Multi-Center, Phase 3, Double-Blind, Randomized, and Controlled Trial of KD019 vs Erlotinib in Subjects With Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Progressed After First- or Second-Line Chemotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01487174
• Other study ID #: KD019-301
• Status: Terminated
• Phase: Phase 3
• Start date: December 14, 2011
• Est. completion date: July 25, 2013

Study information

• Verified date: May 2022
• Source: Kadmon Corporation, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: July 25, 2013
• Est. primary completion date: July 25, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

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

Locations

Country	Name	City	State
United States	San Juan Oncology Associates	Farmington	New Mexico
United States	Yale Cancer Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Kadmon Corporation, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number and type of adverse events related to KD019	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.	Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
Secondary	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