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A Randomized Phase 3 Study Comparing Pemetrexed Plus Cisplatin With Gemcitabine Plus Cisplatin as First-Line Treatment in Patients With Advanced Non-squamous Non-Small Cell Lung Cancer.

Phase 3
18 Years
Not Enrolling
Non Small Cell Lung Cancer

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Trial Information

A Randomized Phase 3 Study Comparing Pemetrexed Plus Cisplatin With Gemcitabine Plus Cisplatin as First-Line Treatment in Patients With Advanced Non-squamous Non-Small Cell Lung Cancer.

Inclusion Criteria:

- Present with histologically proven or cytological diagnosis of non-squamous NSCLC
Stage IIIB or IV.

- Patients 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 patients 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.

- Patient 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 patient'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 patient 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

Randomization to date of death from any cause (up to 24 month follow-up)

Safety Issue:


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


China: Food and Drug Administration

Study ID:




Start Date:

November 2009

Completion Date:

November 2012

Related Keywords:

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