At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed NSCLC, Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or Stage IV
- ✓Prior induction therapy with exactly one chemotherapeutic doublet of specific platinum-based combinations (gemcitabine, paclitaxel, or docetaxel plus carboplatin or cisplatin) for 4 cycles on 21-day cycles
- ✓Documented tumor response of complete response, partial response, or stable disease after induction therapy
- ✕Prior systemic anticancer therapy outside the specified induction regimens, including adjuvant early-stage NSCLC treatment or treatment for any other cancer
- ✕Received an unapproved investigational drug within 30 days of study entry
- ✕Serious cardiac condition: myocardial infarction within 6 months, angina, or NYHA Class III/IV heart disease
- ✕Serious concomitant systemic disorder compromising ability to complete the study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment for Advanced Non-Small Cell Lung Cancer
In Brief
A Phase 3 clinical trial evaluating Pemetrexed, Placebo, and 1 other intervention for Non-Small Cell Lung Cancer. Completed, enrolled 663 participants across 73 sites in 20 countries.
Detailed Summary
This study is a randomized Phase 3, double-blind study of maintenance pemetrexed plus best supportive care versus placebo plus best supportive care in NSCLC. Participants must have received 1 of 6 induction regimens for 4 cycles and did not have progressive disease prior to randomization (enrollment) into this trial.
Study Details
Timeline
Interventions
500 milligrams per square meter (mg/m\^2), intravenous (IV) administration, every (q) 21 days, until disease progression
IV administration, q 21 days
Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.