NCT04476797

Phase I/II Study of SBRT and GC4711 for Centrally Located or Large NSCLC

GRECO-1: Phase I/II, Randomized, Placebo-Controlled Study of Stereotactic Body Radiation Therapy (SBRT) and GC4711 for Centrally Located or Large, Node-Negative Non-Small Cell Lung Cancer (NSCLC)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Galera Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

GTI-4711-101 is a Phase I/II study of the safety of GC4711, its effect on in-field tumor response and its potential to reduce radiation-related pulmonary injury due to SBRT for lymph node negative (T1 to T3N0M0) peripheral or central localized (within 2cm of the proximal bronchial tree) NSCLC. After an open-label, Phase 1, safety cohort of 5 subjects has been completed, a randomized, placebo-controlled Phase 2 portion of 66 subjects will be conducted.

Detailed description

Subjects must be referred for SBRT with large peripheral lesions (\>1cm-7cm) and/or central localized, node negative, non-metastatic NSCLC, and have an ECOG PS score of 0-3. Feasibility of SBRT is judged by the treating physician. SBRT is planned for the tumor location as a dose of or 3 fractions of 18-20 Gy (Phase 2 only) or 5 fractions of 10-12 Gy. SBRT fractions will be given within 180 minutes from the end of the GC4711 or placebo infusion. After completion of Phase I, a Phase II, randomized, placebo-controlled study will be initiated, wherein approximately 66 subjects referred for SBRT with early stage large and/or central localized NSCLC will be randomized in a 1:1 ratio to receive either GC4711 or placebo given intravenously (IV) over 15 minutes before each fraction of SBRT, beginning the day of the first fraction of SBRT and ending the last day of SBRT. Subjects will be monitored for treatment emergent adverse events for 30 days post SBRT completion. Additionally, subjects will be monitored 90 days post-SBRT for all adverse events to evaluate acute toxicities, and monitored for 1-year post-SBRT completion for specific late toxicities. In-field tumor response and overall survival will be evaluated through 24 months post SBRT completion.

Conditions

• SBRT
• NSCLC
• Non-metastatic

Interventions

Type	Name	Description
DRUG	GC4711 +SBRT	15 minute IV Infusion prior to SBRT
DRUG	Placebo +SBRT	15 minute IV infusion prior to SBRT

Timeline

• Start date: 2020-10-18
• Primary completion: 2023-11-28
• Completion: 2023-11-28
• First posted: 2020-07-20
• Last updated: 2024-04-30
• Results posted: 2024-04-03

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study