Clinical trial NCT01836575 (phase 3, status: completed)
Conditions: non small cell lung carcinoma
ICD codes: D02.20, D02.21, D02.22
Drugs: pemetrexed, carboplatin
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H], N[C@@H](CCCNC(N)=N)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed NSCLC in stage IIIB (with a cytologically positive pleural or
             pericardial effusion) or stage IV, according to the sixth edition of the American
             Joint Committee on Cancer (AJCC) Cancer Staging Manual37;

          -  Age > 18 years;

          -  No prior chemotherapy, including adjuvant or neoadjuvant therapy, for the treatment of
             NSCLC;

          -  Histological confirmation of any non-squamous histological type of NSCLC, given the
             recent findings of treatment benefit in this population44;

          -  ECOG performance status of 2;

          -  At least 3 weeks must have elapsed since major surgery, and at least 1 week since
             mediastinoscopy, pleuroscopy, or thoracostomy;

          -  Patients must have measurable disease, defined as lesions that can be accurately
             measured in at least 1 dimension (longest diameter to be recorded) as ≥ 20 mm with
             conventional techniques (computed tomography [CT] or magnetic resonance imaging [MRI]
             scan) or as ≥ 10 mm with spiral CT scan;

          -  Adequate organ function as indicated by the following:

               -  White blood cell (WBC) count ≥ 3500/mm3

               -  Absolute neutrophil count (ANC) ≥1500/mm3

               -  Hemoglobin ≥ 9.0 g/dL

               -  Platelet count ≥ 100,000/ mm3

               -  Total bilirubin ≤ 2 times the upper limit of normal (ULN)

               -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the
                  ULN, unless liver metastases present, in which case AST and ALT have to be ≤ 5
                  times the ULN

               -  Estimated glomerular filtration rate (GFR) ≥ 45 mL/min

          -  Female patients of childbearing potential must have a negative serum pregnancy test
             within 7 days prior to registration;

          -  Fertile patients (male or female) must agree to use an acceptable method of
             contraception to avoid pregnancy for the duration of the study and for 3 months
             thereafter;

          -  Patients must sign an Informed Consent Form;

          -  Have the ability to take folic acid, Vitamin B12, and dexamethasone according to
             protocol requirements;

        Exclusion Criteria:

          -  ECOG performance status other than 2;

          -  Prior chemotherapy for the treatment of NSCLC;

          -  Lesions that have been irradiated cannot be included as sites of measurable disease.
             If the only measurable lesion was previously irradiated the patient cannot be
             included;

          -  Symptomatic central nervous system (CNS) metastases. Prior CNS metastases are allowed
             if the patient is neurologically stable and not receiving corticosteroids;

          -  Serious uncontrolled intercurrent medical or psychiatric illness;

          -  Active and ongoing systemic infection;

          -  Second primary malignancy (except in situ carcinoma of the cervix, in situ carcinoma
             of the bladder, adequately treated basal-cell carcinoma of the skin, adequately
             treated squamous-cell carcinoma of the skin, T1 vocal cord cancer in remission, or
             prior malignancy treated more than 5 years prior to enrollment and without
             recurrence);

          -  Known hypersensitivity to pemetrexed;

          -  known hypersensitivity to carboplatin;

          -  Pregnancy or lactation;

          -  Use of any investigational agent within 30 days prior to enrollment into the study;

          -  Unable to discontinue administration of non-steroidal anti-inflammatory (NSAIDSs)
             agents for 2 days before, the day of and 2 days after the dose of pemetrexed, in the
             case of NSAIDs with short half-life, such as ibuprofen (total of 5 days), in patients
             with a GFR between 45 and 79 mL/min; and for 5 days before, the day of and 2 days
             after the dose of pemetrexed, in the case of NSAIDs with long half-life (total of 8
             days, see 7.4.2) in all patients; patients with a GFR ≥ 80 mL/min may receive
             concomitant study treatment and ibuprofen or aspirin (≤ 1.3 g/day);

          -  Inability to comply with requirements and procedures of study.