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

NCT04476797 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2024-04-30

Study results available
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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.

Conditions

  • SBRT
  • NSCLC
  • Non-metastatic

Interventions

DRUG

GC4711 +SBRT

15 minute IV Infusion prior to SBRT

DRUG

Placebo +SBRT

15 minute IV infusion prior to SBRT

Sponsors & Collaborators

  • Galera Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Eugene P Kennedy, MD · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-18
Primary Completion
2023-11-28
Completion
2023-11-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04476797 on ClinicalTrials.gov