Clinical trial NCT00118183 (phase 2, status: completed)
Conditions: adenocarcinoma of the lung, adenosquamous cell lung cancer, large cell lung cancer, malignant pleural effusion, recurrent non-small cell lung cancer, squamous cell lung cancer, stage iiib non-small cell lung cancer, stage iv non-small cell lung cancer
ICD codes: D02.20, D02.21, D02.22, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: docetaxel, bortezomib
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        Inclusion Criteria:

          -  All patients must have histologically or cytologically documented non-small cell
             carcinoma of the lung (adenocarcinoma, large cell, squamous, or mixtures of these
             types)

          -  Patients with stage IV disease are eligible

          -  Patients with stage IIIB due to a malignant pleural effusion or supraclavicular node
             involvement are eligible (IIIB patients eligible for CALGB protocols of combined
             chemotherapy and thoracic radiotherapy are not eligible)

          -  Patients with known CNS metastases who have received therapy (surgery, XRT, gamma
             knife), and are neurologically stable and off steroids by the time of enrollment are
             eligible if they are not on enzyme-inducing anticonvulsants; patients with
             leptomeningeal disease are not eligible

          -  Documentation of PS 2 must be noted on form C-1392

          -  Patients must have measurable or non-measurable disease

          -  Measurable disease (target lesions): lesions that can be accurately measured in at
             least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional
             techniques or as ≥ 10 mm with spiral CT scan

          -  Non-measurable disease (non-target lesions): all other lesions, including small
             lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral
             CT scan) and truly nonmeasurable lesions; lesions that are considered non-measurable
             include the following:

               -  Bone lesions

               -  Ascites

               -  Pleural/pericardial effusion

               -  Lymphangitis cutis/pulmonis

               -  Abdominal masses that are not confirmed and followed by imaging techniques

               -  Cystic lesions

          -  No prior systemic treatment for advanced NSCLC is permitted; prior treatment for
             early-stage disease (adjuvant) or for locally-advanced stage III disease is allowed if
             completed at least 12 months prior to registration

          -  Patients must have recovered (all toxicities ≤ grade 1) from prior surgery and/or
             radiotherapy

          -  No prior therapy which specifically and directly targets the EGFR pathway

          -  No prior severe infusion reactions to a monoclonal antibody

          -  No ≥ grade 2 peripheral neuropathy

          -  Non-pregnant and non-nursing

          -  No concurrent treatment with any other investigational therapy

          -  Granulocytes ≥ 1,500/μl

          -  Platelets ≥ 100,000/μl

          -  Serum creatinine ≤ ULN

          -  Bilirubin ≤ ULN

          -  AST ≤ ULN