Paclitaxel-Carboplatin-Bevacizumab +/- Nitroglycerin in Metastatic Non-Squamous-Non-Small Cell Lung Cancer
Status:
Completed
Trial end date:
2020-08-01
Target enrollment:
Participant gender:
Summary
This study is designed to assess the effects of adding nitroglycerin (NTG) patches, delivery
25 mg NTG per 24 h, to the standard first line treatment of metastatic non-squamous non-small
cell lung cancer (NSCLC), i.e. 4 cycles of carboplatin-paclitaxel-bevacizumab, followed by
bevacizumab alone until disease progression. Tumor hypoxia is a common phenomenon in lung
cancer; it is a known poor prognostic marker, related to treatment resistance. Pre-clinical
studies have shown that nitric oxide (NO) donating drugs may decrease hypoxia related drug
resistance. NTG is a NO donating drug. NTG increases tumor blood flow and thereby augments
antitumor drug delivery to the tumor.
A randomized phase II has shown an increase in the response rate from 42% to 72%, when NTG
patches (25 mg/day, day -2 to +3) were added to vinorelbine/cisplatin in patients with
advanced NSCLC. In addition, the time to progression increased from 185 to 327 days.
The hypothesis of the present study is that adding NTG transdermal patches to bevacizumab
containing chemotherapy improves progression free survival, response rate and overall
survival in patients with metastatic non-squamous NSCLC.
Phase:
Phase 2
Details
Lead Sponsor:
Dutch Society of Physicians for Pulmonology and Tuberculosis