Summary
Lung cancer is the most common cause of cancer-related deaths. Although some improvements in the treatment of early stage lung cancer have occurred, the majority of participants still present with advanced (non-operable) disease. The treatments for participants with advanced lung cancer are mostly palliative using various treatments, including chemotherapy, targeted therapies and radiotherapy. This study looks at whether response rates to an assay-directed chemotherapy regime - adenosine triphosphate tumour cell assay (ATP-TCA) - may be greater than in patients who are receiving current, standard chemotherapy for lung cancer. Who is it for? You may be eligible for this study if you have had a confirmed diagnosis of inoperable non small cell lung cancer or mesothelioma, are 18 years and above in age, have an ECOG performance status of 0, 1 or 2, and adequate bone marrow, hepatic and renal function as determined by clinical assessments. Trial details In this trial, you will be treated with either an assay-directed chemotherapy regime, ATP-TCA, or your physicianÆ’??s choice of standard therapy for your condition. Which treatment you will receive will be determined by randomisation. If you are randomised to the ATP-TCA arm, you will be offered therapy based on your chemo-sensitivity profiles, from which a list of drugs that were positive on the ATP-TCA assay will be provided to your treating oncologist to decide the best first-line chemotherapy agents for you, provided in standard doses based on current clinical practice. The chemotherapy drugs that will be tested in the ATP-TCA assays include: Carboplatin, Docetaxel, Pemetrexed, Vineralbine, Gemcitabine, Irinotecan or Paclitaxel +albumin (Abraxane). If you are randomised to the standard chemotherapy treatment, you will receive carboplatin and docetaxel administered every 3 weeks in standard doses. For both treatments, a total of 6 cycles will be administered providing there is evidence of stable disease or partial or complete response by the RECIST criteria. CT scans will be performed after the 3rd and 6th cycles of chemotherapy treatment. Should your disease progress past what is deemed suitable, your treating oncologist will then remove you from the study. Quality of-life assessments will be performed prior to cycle three of chemotherapy and following cycle The aim of this study is to test the hypothesis that the results of chemotherapy in non small cell lung cancer can be improved by predictive testing without an unacceptable increase in toxicity.