A Phase III, randomised trial of adding nitroglycerin to first line chemotherapy for advanced non-small cell lung cancer

Funding

Charities/Societies/Foundations,WA Cancer Council

Scientific enquiries

A/Prof Andrew Davidson

Brief Summary

This study will evaluate the efficacy of adding the drug, nitroglycerin, to first line chemotherapy for advanced non-small cell lung cancer. Who is it for? You may be eligible to join this study if you are 18 years or above and have a confirmed diagnosis of stage III or IV non-small cell lung cancer. Radiotherapy should have been completed at least one week before commencing treatment in this study. Trial details Participants in this trial will be randomly (by chance) allocated to one of two gro .... This study will evaluate the efficacy of adding the drug, nitroglycerin, to first line chemotherapy for advanced non-small cell lung cancer. Who is it for? You may be eligible to join this study if you are 18 years or above and have a confirmed diagnosis of stage III or IV non-small cell lung cancer. Radiotherapy should have been completed at least one week before commencing treatment in this study. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Both groups undergo 6 x 3 week treatment cycles of standard chemotherapy determined by their doctor. In addition, participants in group one will receive nitroglycerin administered as a 25mg patch for 12 hours each day for 2 days before, the day of, and for two days after each chemotherapy injection. Participants will undergo regular visits to the hospital and undergo CT scans prior to treatment, every six weeks during chemotherapy, and every two months after chemotherapy until the lung cancer has progressed. This will help determine which treatment is more effective in terms of progression-free survival and overall survival.
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Key Inclusion Criteria

Confirmed diagnosis of stage III or IV non-small cell lung cancer Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 Adequate bone marrow, kidney and liver function Radiotherapy completed at least 1 week before randomisation Patient is willing and able to comply with protocol requirements Patient has completed quality of life questionnaires or is unable to complete due to illiteracy, language or limited vision Female patients of childbearing potential must be willing to us .... Confirmed diagnosis of stage III or IV non-small cell lung cancer Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 Adequate bone marrow, kidney and liver function Radiotherapy completed at least 1 week before randomisation Patient is willing and able to comply with protocol requirements Patient has completed quality of life questionnaires or is unable to complete due to illiteracy, language or limited vision Female patients of childbearing potential must be willing to use adequate contraception Plan to start chemotherapy within 8 days of randomisation
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Key Exclusion Criteria

Untreated brain or meningeal metastases Life expectancy less than 3 months Any prior systemic therapy for advanced non-small cell lung cancer History of previous or concomitant malignancies at other sites within the last 5 years On nitrates, dihydroergotamine or phosphodiesterase inhibitors History of allergic disease or reactions likely to be exacerbated by nitroglycerin Uncontrolled cardiovascular disease Other concomitant medical problems which would limit compliance with the study procedures .... Untreated brain or meningeal metastases Life expectancy less than 3 months Any prior systemic therapy for advanced non-small cell lung cancer History of previous or concomitant malignancies at other sites within the last 5 years On nitrates, dihydroergotamine or phosphodiesterase inhibitors History of allergic disease or reactions likely to be exacerbated by nitroglycerin Uncontrolled cardiovascular disease Other concomitant medical problems which would limit compliance with the study procedures or expose the patient to unacceptable risk Active and uncontrolled infections
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