Phase I/II Study of SBRT and GC4711 for Centrally Located or Large NSCLC (GRECO-1)
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| ClinicalTrials.gov Identifier: NCT04476797 |
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Recruitment Status :
Recruiting
First Posted : July 20, 2020
Last Update Posted : February 8, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| SBRT NSCLC Non-metastatic | Drug: GC4711 Drug: Placebo | Phase 1 Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 71 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | After the open label Phase 1 portion, subjects in the Phase2 portion will be randomized in a 1:1 ratio to receive GC4711 or placebo before each fraction of SBRT |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Masking Description: | Phase 2 is a randomized, placebo-controlled study |
| Primary Purpose: | Treatment |
| Official Title: | 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) |
| Actual Study Start Date : | October 18, 2020 |
| Estimated Primary Completion Date : | June 2024 |
| Estimated Study Completion Date : | December 2025 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: GC4711 + SBRT |
Drug: GC4711
15 minute IV Infusion prior to SBRT |
| Placebo Comparator: Placebo + SBRT |
Drug: Placebo
15 minute IV infusion prior to SBRT |
- Number of dose-limiting toxicities during treatment and within 30 days post SBRT [ Time Frame: DLT 30 days post SBRT ]Phase 1
- Percent of patients with a best RECIST response of CR or PR amongst all responses through Month 6 [ Time Frame: 6 months post SBRT ]Phase 2
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
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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 Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04476797
| Contact: Megan Holm | 484-615-2036 | mholm@galeratx.com | |
| Contact: Eugene P Kennedy, MD | 484.870.9616 |
| United States, Arizona | |
| Banner MD Anderson Cancer Center | Withdrawn |
| Gilbert, Arizona, United States, 85234 | |
| United States, Colorado | |
| Banner MD Anderson Cancer Center at NCMC | Recruiting |
| Greeley, Colorado, United States, 80631 | |
| Contact: Supriya Jain, MD 970-810-6690 | |
| Principal Investigator: Supriya Jain, MD | |
| Banner McKee Medical Center | Recruiting |
| Loveland, Colorado, United States, 80538 | |
| Contact: Supriya Jain, MD 970-810-6690 | |
| Contact: Kimberly Reyna 970-820-5982 | |
| Principal Investigator: Supriya Jain, MD | |
| United States, Georgia | |
| IACT Health | Recruiting |
| Columbus, Georgia, United States, 31903 | |
| Contact: Douglas Ciuba, MD 706-596-5413 | |
| Principal Investigator: Douglas Ciuba, MD | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Sandy Vollstedt 319-353-7143 | |
| Principal Investigator: Bryan Allen, MD | |
| United States, Kansas | |
| University of Kansas Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Contact: David Akhavan 913-588-6046 | |
| Principal Investigator: David Akhavan, MD | |
| United States, Michigan | |
| Henry Ford Hospital | Withdrawn |
| Detroit, Michigan, United States, 48208 | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Tykeytra Dale 919-668-3726 | |
| Contact: Linda Kaltenback 919-681-6804 | |
| Principal Investigator: Christopher Kelsey, MD | |
| United States, Ohio | |
| University Hospitals Cleveland Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Tithi Biswas, MD 216-844-5336 | |
| Principal Investigator: Tithi Biswas, MD | |
| United States, South Carolina | |
| Gibbs Cancer Center & Research Institute | Recruiting |
| Spartanburg, South Carolina, United States, 29303 | |
| Contact: Amy Curtis, MD 864-560-6954 | |
| Principal Investigator: Amy Curtis, MD | |
| United States, Texas | |
| The University of Texas Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Jessica Curtin 214-645-3622 | |
| Principal Investigator: Puneeth Iyengar, MD | |
| United States, Washington | |
| Providence Regional Medical Center | Recruiting |
| Everett, Washington, United States, 98201 | |
| Contact: William Wisbeck, MD 425-297-5500 | |
| Principal Investigator: William Wisbeck, MD | |
| Cancer Care Northwest | Recruiting |
| Spokane, Washington, United States, 99218 | |
| Contact: Orlan MacDonald, MD 509-228-1000 | |
| Principal Investigator: Orlan MacDonald, MD | |
| Study Chair: | Eugene P Kennedy, MD | Chief Medical Officer |
| Responsible Party: | Galera Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT04476797 |
| Other Study ID Numbers: |
GTI-4711-101 |
| First Posted: | July 20, 2020 Key Record Dates |
| Last Update Posted: | February 8, 2023 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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lymph node negative NSCLC centrally located NSCLC large NSCLC SBRT |
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Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |