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Radiosensitizer
GC4711 + SBRT for Non-Small Cell Lung Cancer (GRECO-1 Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by Galera Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 12 months, 18 months and 24 months post sbrt and gc4711+placebo
Awards & highlights
GRECO-1 Trial Summary
This trial is studying a potential new cancer treatment called GC4711 to see if it is safe and effective. So far, it seems to be safe, and they are now testing it on a larger group of people to see if it works.
Eligible Conditions
- Non-Small Cell Lung Cancer
- Stereotactic Body Radiation Therapy
- Non-Metastatic
GRECO-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months, 12 months, 18 months and 24 months post sbrt and gc4711+placebo
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 12 months, 18 months and 24 months post sbrt and gc4711+placebo
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent of Patients With a Complete Response or Partial In-field Tumor Response Based on the RECIST 1.1 Criteria Through 6 Months Following SBRT.
Side effects data
From 2023 Phase 3 trial • 455 Patients • NCT0368971288%
Lymphopenia
86%
Nausea
71%
Fatigue
64%
Constipation
61%
Oropharyngeal Pain
57%
Dysgeusia
56%
Vomiting
54%
Dry Mouth
52%
Radiation Skin Injury
48%
Weight Decreased
15%
Paresthesia
6%
Febrile Neutropenia
3%
Pulmonary Embolism
3%
Dehydration
2%
Pyrexia
2%
Sepsis
1%
Pneumonia
1%
Dysphagia
1%
Decreased Appetite
1%
Device Malfunction
1%
Hypotension
1%
Hypoxia
1%
Malnutrition
1%
Cardiac failure congestive
1%
Hepatitis viral
1%
Pneumonia Aspiration
1%
Failure to Thrive
1%
Deep Vein Thrombosis
1%
Lung Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
GC4419 (Avasopasem Manganese) 90 mg
Placebo
GRECO-1 Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 2 GC4711 +SBRTExperimental Treatment1 Intervention
Group II: Phase 1 GC4711 + SBRTExperimental Treatment1 Intervention
Group III: Phase 2 Placebo + SBRTPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Galera Therapeutics, Inc.Lead Sponsor
16 Previous Clinical Trials
1,303 Total Patients Enrolled
Jon Holmlund, MDStudy ChairChief Medical Officer
6 Previous Clinical Trials
343 Total Patients Enrolled
Eugene P Kennedy, MDStudy ChairChief Medical Officer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received immunotherapy treatment in the 3 months before starting the study.You had radiation therapy or surgery in the chest area that overlaps with the planned radiation treatment.You have had allergic reactions to drugs that are similar to GC4711.People with small peripheral lesions (1cm or less) are not eligible.You have a certain level of physical ability, ranging from full activity to being mostly in bed.You have a specific type and stage of lung cancer that can be treated with a type of radiation called SBRT.Your blood counts, kidney function, and liver function are within normal range.You have an illness or condition that is not under control, such as an ongoing infection, heart problems, or mental health issues that could make it hard for you to follow the study guidelines.You are taking medications that could cause a sudden drop in blood pressure.You have been diagnosed with non-small cell lung cancer through a tissue sample or biopsy.You have not fully recovered from side effects caused by previous treatments like chemotherapy or targeted therapy, according to your doctor's judgment.You have a type of cancer other than lung cancer that is not being controlled with treatment.You have been diagnosed with cancer that has spread beyond the original site, according to the local doctor's tests.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 GC4711 +SBRT
- Group 2: Phase 2 Placebo + SBRT
- Group 3: Phase 1 GC4711 + SBRT
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Where are the trial sites for this experiment?
"There are a total of 13 sites where this trial is taking place. A few examples include Cancer Care Northwest in Spokane, Washington, University of Iowa Hospitals and Clinics in Iowa City, Iowa, and University of Kansas Medical Center in Kansas City, Kansas."
Answered by AI
Are patients being recruited for this trial at present?
"Yes, this information can be found on the website clinicaltrials.gov. The trial was originally posted on 10/18/2020 and was most recently edited on 8/9/2022. They are currently recruiting for 71 participants between 10 sites."
Answered by AI
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