Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed; Placebo; Best Supportive Care
Intervention description: 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.
Intervention MeSH terms: Pemetrexed
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 663.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic diagnosis of NSCLC Stage IIIB (with pleural effusion and/or
             positive supraclavicular lymph nodes) or Stage IV prior to induction therapy.

          -  Participants must have had 1 of the following induction therapies for treatment for
             Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or IV
             NSCLC: Gemcitabine plus carboplatin, paclitaxel plus carboplatin, or docetaxel plus
             carboplatin, gemcitabine plus cisplatin, paclitaxel plus cisplatin or docetaxel plus
             cisplatin.

          -  Participants must have received only 1 chemotherapeutic doublet lasting precisely 4
             cycles.

          -  Induction regimens must be based on 21-day cycles.

          -  Documented evidence of a tumor response of complete response (CR), partial response
             (PR), or stable disease (SD). Tumor assessment must occur between Cycle 4 (Day 1) of
             induction therapy and the date of randomization. This response does not have to be
             confirmed in order for the participant to be randomized. Positron emission tomography
             (PET) scans and ultrasounds may not be used for lesion measurements for response
             determination.

        Exclusion Criteria:

          -  With the exception of those chemotherapies listed as inclusion criterion, participants
             will not be included if they have received prior systemic anticancer therapy
             (including adjuvant early-stage treatment for NSCLC) or any systemic treatment for any
             other cancer.

          -  Have received treatment within the last 30 days with a drug that has not received
             regulatory approval for any indication at the time of study entry.

          -  Inability to comply with protocol or study procedures.

          -  A serious concomitant systemic disorder that 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.