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An Exploratory Phase 2 Study of Pemetrexed/Cisplatin as Pre-operative Chemotherapy in the Treatment of Stage IIIAN2 Nonsquamous Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

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Trial Information

An Exploratory Phase 2 Study of Pemetrexed/Cisplatin as Pre-operative Chemotherapy in the Treatment of Stage IIIAN2 Nonsquamous Non-Small Cell Lung Cancer


Inclusion Criteria:



- Nonsquamous Non Small Cell Lung Cancer that was confirmed by tissue biopsy

- Stage IIIAN2 disease (T1aN2, T1bN2, T2aN2, T2bN2, and T3N2)

- Tumor considered potentially resectable

- Good performance status (score of 0 or 1) according to Eastern Cooperative Oncology
Group scale)

- No prior therapy for lung cancer

- Measurable disease according to version 1.1 of RECIST Criteria

- Life expectancy of at least 6 months

- Organs are functioning well (bone marrow reserve, liver, kidney, lung)

- Signed Informed Consent

- Women must be surgically sterile, postmenopausal, or compliant with a medically
approved contraceptive regimen (for example, intrauterine device, birth control
pills, or barrier device) during and for 6 months after last dose of study drug; must
have a negative pregnancy test within 7 days before study enrollment; and must not be
breast-feeding.

- Men must be surgically sterile,or compliant with a contraceptive regimen during and
for 6 months after last dose of study drug.

- Be fit for surgery at the time of enrollment

Exclusion Criteria:

- Receiving or have received an investigational drug or device within the last 30 days

- Have previously completed or withdrawn from this study or any other study
investigating pemetrexed

- Serious concomitant systemic disorder

- Serious cardiac condition, such as myocardial infarction within 6 months, angina, or
heart disease

- Receiving concurrent administration of any other anticancer therapy

- Have received a recent (within 30 days of enrollment) or are receiving concurrent
yellow fever vaccination

- Inability or unwillingness to take Pemetrexed supplementation/ premedication (folic
acid, vitamin B12 , or corticosteroids

- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other
than an aspirin dose less than or equal to 1.3 grams per day

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients whose response is a complete response (CR) or partial response (PR)

Outcome Time Frame:

From study enrollment until disease progression (PD) or recurrence

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:

Italy: The Italian Medicines Agency

Study ID:

13621

NCT ID:

NCT01165021

Start Date:

November 2010

Completion Date:

March 2016

Related Keywords:

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

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