clinical trial · NCT05616624
ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers
Non Small Cell Lung CancerNon-small Cell Lung CancerSmall-cell Lung CancerSmall Cell Lung CarcinomaADI-PEG 20GemcitabineDocetaxel
brief summary
In this study, patients with small cell or non-small cell lung cancer will receive ADI-PEG 20, gemcitabine, and docetaxel after demonstrated progression on frontline therapy. In phase I of the study, up to 6 dose levels will be tested to find the recommended phase II dose (RP2D), after which patients enrolling to phase II will be treated at that dose level to assess efficacy. Although safety and tolerability has been previously determined in the sarcoma population, dose de-escalations of the chemotherapies in that patient population were required. Therefore, a phase I portion will be incorporated to determine the RP2D of the triplet in this population.
started
Apr 5, 2023
primary completion
Jul 22, 2026
completion
Jul 22, 2026
last updated
Jul 27, 2026
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol