A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Eli Lilly and Company1,713 enrolled

Overview

This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,713

Conditions

Non Small Cell Lung Carcinoma

Interventions

pemetrexedDRUG

500 mg/m2, IV q 21 days x 6 cycles

gemcitabineDRUG

1250 mg/m2, IV, day 1 and 8 q 21 days x 6 cycles

cisplatinDRUG

75 mg/m2, IV, q 21 days x 6 cycles

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of NSCLC Stage IIIB not amenable to curative treatment or Stage IV. * No prior chemotherapy for lung cancer. * Patients must have at least one uni-dimensionally measurable lesion. * Prior radiation therapy to less than 25% of bone marrow, whole pelvis not allowed. Radiation must be completed at least 4 weeks prior to study enrollment. Exclusion Criteria: * Treatment with any drug within the last 30 days that has not received regulatory approval. * Serious cardiac condition. * Serious medical disorder in addition to NSCLC that would make it difficult for the patient to complete the study. * Inability or unwillingness to take folic acid or Vitamin B12 supplementation. * Presence of fluid retention that cannot be controlled by drainage.

Locations (134)

Outcomes

Primary Outcomes

Overall survival

Time frame: baseline to date of death from any cause

Secondary Outcomes

Progression free survival

Time frame: baseline to measured progressive disease

Time to progressive disease

Time frame: baseline to measured progressive disease

Duration of response

Time frame: time of response to progressive disease

Time to treatment failure

Time frame: baseline to stopping treatment

Data from ClinicalTrials.gov

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Sacramento, California, United States

Torrance, California, United States

Jacksonville, Florida, United States

Macon, Georgia, United States

Wichita, Kansas, United States

Lexington, Kentucky, United States

Scarborough, Maine, United States

Duluth, Minnesota, United States

St Louis, Missouri, United States

Billings, Montana, United States

...and 124 more locations