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

Phase 3TerminatedNCT01487174

Kadmon Corporation, LLC8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

KD019DRUG

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

ErlotinibDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Yale Cancer Center

New Haven, Connecticut, United States

San Juan Oncology Associates

Farmington, New Mexico, United States

Outcomes

Primary Outcomes

Overall survival

Time frame: 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

Time frame: 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

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.

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

Objective response rate

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

Data from ClinicalTrials.gov

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