Status:
TERMINATED
Phase I/II Study of SBRT and GC4711 for Centrally Located or Large NSCLC
Lead Sponsor:
Galera Therapeutics, Inc.
Conditions:
SBRT
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
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 jud...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
October 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2023
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04476797
Start Date
October 18 2020
End Date
November 28 2023
Last Update
April 30 2024
Active Locations (10)
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1
Banner MD Anderson Cancer Center at NCMC
Greeley, Colorado, United States, 80631
2
Banner McKee Medical Center
Loveland, Colorado, United States, 80538
3
IACT Health
Columbus, Georgia, United States, 31903
4
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242