Post-marketing Clinical Trial of Induction Chemotherapy of Pemetrexed Plus Carboplatin Followed by Pemetrexed Maintenance Therapy for Advanced Nonsquamous Non-small Cell Lung Cancer
20 Years
N/A
Both
Non Small Cell Lung Cancer
Trial Information
Post-marketing Clinical Trial of Induction Chemotherapy of Pemetrexed Plus Carboplatin Followed by Pemetrexed Maintenance Therapy for Advanced Nonsquamous Non-small Cell Lung Cancer
Inclusion Criteria:
- Non-squamous cell Non Small Cell Lung Cancer (NSCLC) disease
- Clinical stage IIIB/IV or recurrent disease after surgery
- No prior systemic chemotherapy, immunotherapy, targeted therapy or biological
therapy, including adjuvant therapy
- Prior radiation therapy is allowed to less than 25% of the bone marrow
- Measurable disease as defined by response evaluation criteria in solid tumors
(RECIST)
- The Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ function
- Estimated life expectancy of at least 12 weeks
Exclusion Criteria:
- Clinically significant third-space fluid collections
- Central nervous system disease other than stable and treated brain metastasis
- More than 3 weeks interval between the surgery and enrollment request date
- Unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs),
for a 5 days period
- Unable or unwilling to take folic acid or vitamin B12 supplementation
- Unable to take corticosteroids.
- Serious concomitant disorder that, in the opinion of the investigator, would
compromise the patient's ability to adhere to the protocol
- Currently have and historically had interstitial pneumonitis (interstitial pneumonia)
or pulmonary fibrosis manifested as opacity on Chest x-ray or Computed tomography
(CT)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival (PFS) During the Induction and Maintenance Therapy Periods
Outcome Description:
PFS defined as time from enrollment date to first date of objective progression of disease or of death from any cause. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy.
Outcome Time Frame:
Enrollment to the date of progressive disease (PD) or the date of death from any cause (up to 18 months)
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:
Japan: Ministry of Health, Labor and Welfare
Study ID:
12628
NCT ID:
NCT01020786
Start Date:
November 2009
Completion Date:
June 2012
Related Keywords:
- Non Small Cell Lung Cancer
- Non-squamous
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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