A Study in Non-squamous Non Small Cell Lung Cancer in Asian Patients

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate efficacy and safety of the combination with pemetrexed plus carboplatin, followed by pemetrexed in patients with advanced nonsquamous Non Small Cell Lung Cancer (NSCLC) who receive at least one dose of the induction therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Carboplatin; Pemetrexed

Criteria

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)