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A Randomized Ph 3 Study Comparing First-Line Pemetrexed/Cisplatin Followed by Gefitinib With Gefitinib Alone in East Asian Never Smoker or Light Ex-Smoker Patients With Locally Advanced or Metastatic Nonsquamous NSCLC


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

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Trial Information

A Randomized Ph 3 Study Comparing First-Line Pemetrexed/Cisplatin Followed by Gefitinib With Gefitinib Alone in East Asian Never Smoker or Light Ex-Smoker Patients With Locally Advanced or Metastatic Nonsquamous NSCLC


Inclusion Criteria:



- Histological diagnosis of NSCLC with locally advanced or metastatic disease that is
of non-squamous histology.

- Patients must be "light ex-smokers" or "never-smokers".

- "Light ex-smokers" defined as having ceased smoking for greater than or equal to
5 years and not to have exceeded 10 pack-years.

- "Never-smokers" are defined as having smoked <100 cigarettes or equivalent
during his/her lifetime.

- Patients must be of East Asian ethnicity.

- No prior systemic therapy for lung cancer.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

- Presence of clinically significant (by physical exam) third-space fluid collections,
for example, ascites or pleural effusions that cannot be controlled by drainage or
other procedures prior to study entry.

- Any evidence of clinically active interstitial lung disease. Asymptomatic patients
with chronic, stable, radiographic changes are eligible.

- Patients whose Epiderla growth Factor Receptor (EGFR) mutation status is known prior
to study entry will be excluded. Patients in which EGFR mutation testing has not been
performed, or whose EGFR mutation status is unknown or inconclusive at study entry
are eligible.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

Every other cycle for 6 cycles then every 6 weeks from the date of randomization to the first date of measured progressive disease or death from any cause

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Korea: Food and Drug Administration

Study ID:

13021

NCT ID:

NCT01017874

Start Date:

November 2009

Completion Date:

October 2014

Related Keywords:

  • Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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