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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01487174

Enrollment

Registered

2011-12-07

Start date

2011-12-14

Completion date

2013-07-25

Last updated

2022-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Brief 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.

Interventions

DRUGKD019

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

DRUGErlotinib

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026