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

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: SBRT, NSCLC, Non-metastatic

In brief

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.

Key facts

Study ID

NCT04476797

Run by

Galera Therapeutics, Inc.

People needed

47

Starts

2020-10-18

Expected to finish

2023-11-28

Last updated by the study team

2024-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects at least 18 years of age.
• Ability to understand and the willingness to sign a written informed consent.
• Histological or biopsy proven NSCLC.
• ECOG performance status of 0-3.
• Node negative (T1 to T3N0M0), centrally located (within 2cm in all directions around the proximal bronchial tree, including ultra-central tumors, abutting the bronchial tree or trachea) or large (>1-7cm) Non-Small Cell Lung Cancer (NSCLC), judged acceptable for SBRT by the treating Investigator
• Adequate end-organ function, based on routine clinical and laboratory workup:
• ANC >1,000 cells/µl, Platelets ≥ 75,000 cells/µl, Hemoglobin ≥ 7.0 g/dl
• Serum creatinine ≤ 2 x ULN or calculated creatinine clearance ≥ 30 ml/min
• Total bilirubin ≤ 1.5 x ULN (or direct bilirubin below the ULN), AST and ALT ≤ 2.5 x ULN
• Males and females of must agree to use effective contraception starting prior to the first day of treatment and continuing after the last dose of GC4711/Placebo for 30 days (females) and 90 days (males).

You may not qualify if…

• Subjects with confirmed nodal and/or distant disease(including brain), according standard workup by local investigator
• Subjects with peripheral lesions 1cm or smaller
• Prior treatment with immunotherapy within 3 months prior to Day 1 dosing.
• Prior intra-thoracic radiotherapy or surgery with substantial overlap to planned radiation fields as determined by the treating radiation oncologist.
• Subjects not recovered/controlled from prior treatment-related (chemotherapy or targeted therapy) toxicities judged by treating physician.
• Uncontrolled malignancy other than lung cancer that requires active treatment or is deemed by the treating physicians to be likely to affect the subject's survival duration.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to GC4711.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
• Participation in other clinical trials actively testing new anti-cancer treatments, unless previously written approval is provided by the Sponsor.
• Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure.
• Female subjects who are pregnant or breastfeeding.
• Any other conditions that, in the Investigator's opinion, might indicate the subject to be unsuitable for the study.

Where it is running

• Banner MD Anderson Cancer Center at NCMC — Greeley, Colorado, United States
• Banner McKee Medical Center — Loveland, Colorado, United States
• IACT Health — Columbus, Georgia, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Gibbs Cancer Center & Research Institute — Spartanburg, South Carolina, United States
• Parkland Health and Hospital System — Dallas, Texas, United States
• The University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Cancer Care Northwest — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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