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

Kadmon

Status and phase: Terminated; Phase 3

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: KD019; Drug: Erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01487174

KD019-301

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8 participants in 2 patient groups

KD019

Experimental group

Description:

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

Treatment:

Drug: KD019

Erlotinib

Active Comparator group

Description:

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

Treatment:

Drug: Erlotinib