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

May 9, 2022 updated by: Kadmon Corporation, LLC

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale Cancer Center
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • San Juan Oncology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KD019
KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
Drug: KD019
KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
Other Names:
  • XL647
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.
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.
Other Names:
  • Tarceva

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kadmon Corporation, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 14, 2011

Primary Completion (Actual)

July 25, 2013

Study Completion (Actual)

July 25, 2013

Study Registration Dates

First Submitted

December 2, 2011

First Submitted That Met QC Criteria

December 5, 2011

First Posted (Estimate)

December 7, 2011

Study Record Updates

Last Update Posted (Actual)

May 13, 2022

Last Update Submitted That Met QC Criteria

May 9, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KD019-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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