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

NCT01487174 — Phase 3, Terminated, 8 participants, Kadmon Corporation, LLC

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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

Registry	NCT01487174
Status	Terminated - Kadmon has made a business decision to terminate the study due to slow enrollment. Note the decision to terminate the study was not related to safety issues
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	8 (Actual)
Sponsor	Kadmon Corporation, LLC (Industry)
Conditions	Carcinoma, Non-Small-Cell Lung
Interventions	KD019, Erlotinib (Drug)
Dates	start 2011-12-14, primary completion 2013-07-25, completion 2013-07-25, first posted 2011-12-07, last updated 2022-05-13
Locations	2 sites in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
KD019	Experimental	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	Active comparator	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.

KD019 (Drug), also known as XL647: KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
Erlotinib (Drug), also known as Tarceva: Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted.

+Outcome measures

Primary outcomes

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 outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (2)

Facility	City	Country	Status
Yale Cancer Center	New Haven, Connecticut	United States
San Juan Oncology Associates	Farmington, New Mexico	United States

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