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

Lilly

Status and phase

Completed

Phase 4

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: Carboplatin

Drug: Pemetrexed

Study type

Interventional

Funder types

Industry

Identifiers

NCT01020786

H3E-JE-JMII (Other Identifier)

12628

Details and patient eligibility

About

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.

Enrollment

109 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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)