A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed; Cisplatin; Placebo; Pemetrexed; Best Supportive Care
Intervention description: Induction therapy: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles; Induction therapy: Cisplatin: 75 mg/m^2, IV, on Day 1 of each 21-day cycle for 4 cycles; Maintenance therapy: Normal saline (0.9% sodium chloride) administered IV on Day 1 every 21-day cycle until progressive disease or treatment discontinuation; Maintenance therapy: 500 mg/m^2, IV, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation.; Best Supportive Care is treatment given with the intent to maximize quality of life. Best Supportive Care excludes any treatment in which the goal is to cure or slow the progression of the study disease. Patients will receive Best Supportive Care as judged by their treating physician. Those therapies considered acceptable include, but are not limited to, palliative radiation to extrathoracic structures, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral).
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: 939.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare progression-free survival in patients with advanced non-squamous
      non-small cell lung cancer. Patients who do not progress following 4 cycles of induction
      treatment with pemetrexed and cisplatin will be randomized 2:1 to receive either maintenance
      pemetrexed or placebo.
    

Eligibility criteria:

        Inclusion Criteria for the Induction Phase:

          -  You must sign an informed consent document for clinical research.

          -  You must have Stage IIIB or IV nonsquamous Non-Small Cell Lung Cancer.

          -  You must at least be able to be physically mobile, take care of yourself, and must be
             up and about and able to perform light activities such as light housework or office
             work.

          -  You are allowed to have had prior radiation therapy as long as it was not to more than
             25% of the bone marrow and did not include the whole pelvis. Thoracic radiation must
             be completed more than 30 days before the study. You must be recovered from the toxic
             effects (except hair loss).

          -  You must have at least 1 measurable tumor lesion according to the Response Evaluation
             Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated by
             computed tomography (CT) Scan.

          -  Your test results assessing the function of your blood forming tissue, kidneys, and
             liver must be satisfactory.

          -  You must be 18 years of age or older.

          -  Women must be sterile, postmenopausal or on contraception and men must be on
             contraception or sterile (e.g. post-vasectomy).

        Exclusion Criteria for the Induction Phase:

          -  You cannot have squamous cell and/or mixed small cell, non-small cell lung cancer

          -  You cannot have received other investigational drugs within the last 30 days of
             entering the trial.

          -  You cannot have previously completed or withdrawn from this study or any other study
             investigating pemetrexed.

          -  You cannot have other serious on-going illnesses including active infections.

          -  You cannot have a serious cardiac condition, such as a heart attack, angina, or heart
             disease within 6 months of entering the trial.

          -  You cannot have had another form of cancer other than superficial basal cell and
             superficial squamous (skin) cell cancer, or carcinoma in situ of the cervix within the
             last 5 years. Patients with a history of low-grade (Gleason score less than or equal
             to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years
             ago.

          -  You cannot have known central nervous system (CNS) metastases, other than treated,
             stable brain metastasis.

          -  You cannot be receiving nor have received any prior systemic anticancer therapy for
             lung cancer (including chemotherapy given after surgery in early-stage treatment).

          -  You cannot have clinically significant third-space fluid collections (e.g. ascites or
             pleural effusions that cannot be controlled by drainage or other procedures).

          -  You cannot have received a recent (within 30 days) or are receiving a yellow fever
             vaccination.

          -  You are unable to stop taking more than 1.3 grams of aspirin on a daily basis or other
             non-steroidal anti-inflammatory drugs (NSAIDs).

          -  You are unable or unwilling to take folic acid, injections of vitamin B12, or
             corticosteroids.

          -  You cannot be pregnant or breastfeeding.

        Inclusion criteria at Randomization for the Maintenance Phase:

          -  You must at least be able to be physically mobile, take care of yourself, and must be
             up and about and able to perform light activities such as light housework or office
             work.

          -  You must have documented radiographic evidence of a tumor response of complete
             response (CR), partial response (PR), or stable disease (SD) according to the Response
             Evaluation Criteria in Solid Tumors (RECIST) guidelines. 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 patient to be randomized to
             the maintenance phase.