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
Official title: ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers
Conditions: Non Small Cell Lung Cancer
Non-small Cell Lung Cancer
Small-cell Lung Cancer
Small Cell Lung Carcinoma
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.
Interventions:
description: -Given 60 minutes (+/- 15 minutes) prior to docetaxel
name: ADI-PEG 20
other_name: PEGylated arginine deiminase
type: Drug
description: -Given over the course of 90 minutes (+/- 10 minutes)
name: Gemcitabine
other_name: Gemzar
type: Drug
description: -Given over the course of 60 minutes (+/- 10 minutes)
name: Docetaxel
other_name: Taxotere
type: Drug
Study arms:
design_group_description: * ADI-PEG 20 is given as an intramuscular injection on a weekly basis (Day 1, 8 and 15) at a dose of 36 mg/m^2. ADI-PEG 20 dosing will start one week prior to the initiation of gemcitabine + docetaxel on Day -7 prior to the initiation of Cycle 1.<br/>* Gemcitabine is given intravenously at the assigned dose level on Day 2 of each cycle.<br/>* Docetaxel is given intravenously at the assigned dose level on Day 1 of each cycle.<br/>* A cycle is defined as 21 days.<br/>* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) per physician discretion or patient request.<br/>* Treatment may continue for up to 34 cycles.
design_group_title: Phase I: ADI-PEG + gemcitabine + docetaxel
design_group_type: Experimental
design_group_description: * ADI-PEG 20 is given as an intramuscular injection on a weekly basis (Day 1, 8 and 15) at a dose of 36 mg/m^2. ADI-PEG 20 dosing will start one week prior to the initiation of gemcitabine + docetaxel on Day -7 prior to the initiation of Cycle 1.<br/>* Gemcitabine is given intravenously at the assigned dose level on Day 2 of each cycle.<br/>* Docetaxel is given intravenously at the assigned dose level on Day 1 of each cycle.<br/>* A cycle is defined as 21 days.<br/>* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) per physician discretion or patient request.<br/>* Treatment may continue for up to 34 cycles.
design_group_title: Phase II Non-small cell lung cancer: ADI-PEG + gemcitabine + docetaxel
design_group_type: Experimental
design_group_description: * ADI-PEG 20 is given as an intramuscular injection on a weekly basis (Day 1, 8 and 15) at a dose of 36 mg/m^2. ADI-PEG 20 dosing will start one week prior to the initiation of gemcitabine + docetaxel on Day -7 prior to the initiation of Cycle 1.<br/>* Gemcitabine is given intravenously at the assigned dose level on Day 2 of each cycle.<br/>* Docetaxel is given intravenously at the assigned dose level on Day 1 of each cycle.<br/>* A cycle is defined as 21 days.<br/>* After Cycle 8, patients may continue on ADI-PEG 20 alone (without gemcitabine and docetaxel) per physician discretion or patient request.<br/>* Treatment may continue for up to 34 cycles.
design_group_title: Phase II Small cell lung cancer: ADI-PEG + gemcitabine + docetaxel
design_group_type: Experimental
Sponsor: Washington University School of Medicine
Collaborators: Polaris Group
Drug name mappings:
name: 盐酸吉西他滨
lang: CN
name: Gemcitabine Hydrochloride
lang: EN
name: ゲムシタビン塩酸塩
lang: JP
name: 多西他赛
lang: CN
name: Docetaxel
lang: EN
name: ドセタキセル
lang: JP
name: Pegargiminase
lang: EN