The primary purpose of this research study is to evaluate how safe, how well tolerated
and how effective a range of doses of L-DOS47 in combination with standard doublet
therapy of pemetrexed/carboplatin in patients with Stage IV (TNM M1a and M1b) recurrent
or metastatic non-squamous Non-Small Cell Lung Cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02309892.
It is planned that patients will receive 4 cycles of combination treatment with L-DOS47 +
pemetrexed/carboplatin. Patients who have not progressed following the 4 cycles of
combination treatment and who have not experienced unacceptable toxicity will have the
opportunity to continue to receive L-DOS47 treatment for as long as there is clinical
benefit and it is well-tolerated, in the opinion of the Investigator, until disease
progression. Patients who are unable to complete 4 cycles of L-DOS47 +
pemetrexed/carboplatin combination treatment due to pemetrexed/carboplatin toxicity will
have the opportunity to continue receiving L-DOS47 treatment following discontinuation of
pemetrexed/carboplatin, for as long as there is clinical benefit and it is
well-tolerated, in the opinion of the Investigator, until disease progression.
Lead OrganizationHelix BioPharma Corporation
