NCT05616624

ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer
• Non-small Cell Lung Cancer
• Small-cell Lung Cancer
• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	ADI-PEG 20	-Given 60 minutes (+/- 15 minutes) prior to docetaxel
DRUG	Gemcitabine	-Given over the course of 90 minutes (+/- 10 minutes)
DRUG	Docetaxel	-Given over the course of 60 minutes (+/- 10 minutes)

Timeline

• Start date: 2023-04-05
• Primary completion: 2026-07-22
• Completion: 2026-07-22
• First posted: 2022-11-15
• Last updated: 2026-04-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study