Clinical trial NCT02211833 (phase 1, status: completed)
Conditions: carcinoma, non-small-cell lung
ICD codes: D02.20, D02.21, D02.22
Drugs: bi 2536, pemetrexed
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Eligibility criteria:

        Inclusion Criteria:

          1. Pathologic or cytologic confirmed diagnosis of NSCLC

          2. Recurrent, advanced or metastatic NSCLC that had progressed following 1 prior
             chemotherapy regimen for advanced disease. Patients could have received prior adjuvant
             chemotherapy as long as the disease free interval was longer than 1 year.

          3. Measurable disease by 1 or more techniques (CT, MRI) according to RECIST criteria

          4. Male or female aged 18 years or older

          5. Life expectancy of at least 3 months

          6. Eastern Cooperative Oncology Group (ECOG) performance score 0-2

          7. Written informed consent that was consistent with International Conference on
             Harmonization (ICH) - Good Clinical Practice (GCP) guidelines

        Exclusion Criteria:

          1. Treatment with an investigational drug in another clinical study within the 28 days
             prior to the start of therapy or concomitantly with this study

          2. Anti-cancer therapy for NSCLC (except radiotherapy for palliative reasons) within the
             28 days prior to Day 1 of treatment period 1 of this trial

          3. Any persisting toxicities that were deemed to be clinically significant from the
             previous therapy

          4. Received more than 1 prior chemotherapy regimen for advanced disease (not including
             prior adjuvant therapy). Patients could have received prior epidermal growth factor
             receptor tyrosine kinase inhibitors

          5. Unwilling or unable to take folic acid and vitamin B12 supplementation

          6. Active brain metastases (stable for <28 days, symptomatic, or requiring concurrent
             steroids). Patients who had received prior whole brain irradiation and whose brain
             metastases were stable according to the criteria above were not excluded

          7. Other active malignancy diagnosed within the past 3 years (other than non-melanomatous
             skin cancer and cervical intraepithelial neoplasia)

          8. Concomitant intercurrent illnesses including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness or social situation that would have limited
             compliance with trial requirement or which were considered relevant for the evaluation
             of the efficacy or safety of the trial drug

          9. Unable or unwilling to interrupt concomitant administration of NSAIDS 5 days prior to
             the day of and up to 2 days after the administration of pemetrexed

         10. Received prior therapy with pemetrexed

         11. Absolute neutrophil count (ANC) ≤1 500/μL, platelet count ≤100 000/μL, or haemoglobin
             <9 mg/dL

         12. Total bilirubin >1.5 mg/dL (26 μmol/L), alanine aminotransferase (ALT) and/or
             aspartate aminotransferase (AST) ≥2.5 x the upper limit of normal (ULN), except in
             cases of known liver metastasis where a maximum 5 x ULN was acceptable

         13. Serum creatinine level >1.5 mg/dL and or creatinine clearance <45 mL/min

         14. Sexually active and unwilling to use a medically acceptable method of contraception

         15. Pregnancy or breast feeding

         16. Known or suspected active alcohol or drug abuse

         17. Unable to comply with the protocol

         18. Any known hypersensitivity to the trial drugs or their excipients