A Study Comparing Two Different Chemotherapy Types in Chinese Patients With Advanced Non Small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed; Gemcitabine; Cisplatin
Intervention description: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles; 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles; 75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles
Intervention MeSH terms: Gemcitabine; Pemetrexed
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 256.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy and safety of two different chemotherapy
      types in the first line treatment of advanced Non-Small Cell Lung Cancer (NSCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with histologically proven or cytological diagnosis of non-squamous non-small
             cell lung cancer (NSCLC) Stage IIIB or IV.

          -  Participants must agree to use a reliable method of birth control during the study and
             for 3 months following the last dose of study drug.

          -  Female participants must not be pregnant.

          -  No prior systemic chemotherapy for lung cancer.

          -  At least one unidimensionally measurable lesion meeting Response Evaluation Criteria
             in Solid Tumors.

          -  Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.

          -  Adequate organ function.

          -  Prior radiation therapy allowed to <25% of the bone marrow.

          -  Signed informed consent document on file.

          -  Estimated life expectancy of greater than or equal to 12 weeks.

          -  Participant compliance and geographic proximity that allow adequate follow up.

        Exclusion Criteria:

          -  Peripheral neuropathy of great than or equal to Common Terminology Criteria for
             Adverse Events (CTCAE) Grade 1.

          -  Inability to comply with protocol or study procedures.

          -  A serious concomitant systemic disorder that, in the opinion of the investigator,
             would compromise the participant's ability to complete the study.

          -  A serious cardiac condition, such as myocardial infarction within 6 months, angina, or
             heart disease, as defined by the New York Heart Association Class III or IV.

          -  Second primary malignancy that is clinically detectable at the time of consideration
             for study enrollment.

          -  Documented brain metastases unless the participant has completed successful local
             therapy for central nervous system metastases and has not taken corticosteroids for at
             least 4 weeks before enrollment.

          -  Presence of clinically significant third-space fluid collections, for example, ascites
             or pleural effusions that cannot be controlled by drainage or other procedures prior
             to study entry.

          -  Significant weight loss (that is, greater than or equal to 10%) over the previous 6
             weeks before study entry.

          -  Concurrent administration of any other anti-tumor therapy.

          -  Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a
             5-day period (8-day period for long-acting agents, such as piroxicam).

          -  Inability or unwillingness to take folic acid or vitamin B12 supplementation.

          -  Inability to take corticosteroids.

          -  Pregnant or breast-feeding.

          -  Are currently enrolled in, or discontinued within the last 30 days from, a clinical
             trial involving an off-label use of an investigational drug or device (other than the
             study drug), or concurrently enrolled in any other type of medical research judged not
             to be scientifically or medically compatible with this study.