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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Kadmon Corporation, LLC
Study ID
NCT01487174
Phase
PHASE3
Status
Terminated

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KD019 — DRUG
    KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
  • Erlotinib — DRUG
    Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted.

Study Details

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.

Key Dates

First listed
Dec 7, 2011
Start date
Dec 14, 2011
Status verified
May 2022
Primary completion
Jul 25, 2013
Completion
Jul 25, 2013

Study Design

Enrollment
8 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: KD019
    KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
  • Active Comparator: 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 Measure

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 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Yale Cancer CenterNew HavenConnecticut06519-
San Juan Oncology AssociatesFarmingtonNew Mexico87401-

Find similar trials in New Haven, CT

By research site
Yale Cancer Center· New Haven, CTSan Juan Oncology Associates· Farmington, NM

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