Open-label, randomized multicenter phase II clinical trial of a toll-like receptor-2 (TLR2) agonist mycobacterium w (Cadi-05) in combination with paclitaxel plus cisplatin versus paclitaxel plus cisplatin in advanced non-small cell lung cancer (NSCLC).

• DOI: 10.1200/jco.2011.29.15_suppl.7501
• Publication Date: 2017-02-23T18:58:03Z
• Authors: C. P. Belani; D. Desai; B. M. Khamar
• Keywords: 0106 biological sciences; 01 natural sciences; 3. Good health

7501 Background: TLR2 agonist, mycobacterium w (Cadi-05), a non-specific immunomodulator and pure Th 1 response enhancer has demonstrated synergistic effects with a number of chemotherapeutic agents. A phase II randomized study was conducted to test the efficacy of the combination of paclitaxel plus cisplatin with or without Cadi-05 as first line treatment of advanced NSCLC. Methods: Two hundred and twenty-one treatment naive patients (pts) with stage IIIB and IV NSCLC were randomized to receive paclitaxel 175mg/m2 IV 3-hour infusion and cisplatin 100mg/m2 IV with or without Cadi-05 administered intradermally, 0.1 ml on each deltoid on the first visit at least 1 week prior to 1st cycle and then on day 8 and 15 of each cycle of chemotherapy. The cycles were repeated every 3 weeks for a total of 4 cycles. Cadi-05 was administered once a month thereafter until progression or for a maximum of 12 months from the start of treatment in the investigational arm. The primary endpoint of the study was overall surviv...