Phase 1/2 Study of SBRT With or Without GC4711 for NSCLC
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04476797 |
Recruitment Status :
Recruiting
First Posted : July 20, 2020
Last Update Posted : March 18, 2021
|
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | July 15, 2020 | ||||||||
First Posted Date ICMJE | July 20, 2020 | ||||||||
Last Update Posted Date | March 18, 2021 | ||||||||
Actual Study Start Date ICMJE | October 18, 2020 | ||||||||
Estimated Primary Completion Date | November 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
|
||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Phase 1/2 Study of SBRT With or Without GC4711 for NSCLC | ||||||||
Official Title ICMJE | Phase 1/2 Study of Stereotactic Body Radiation Therapy (SBRT) With or Without GC4711 for Early Stage, Centrally Located or Large Non-Small Cell Lung Cancer (NSCLC) | ||||||||
Brief Summary | GTI-4711-101 is a Phase 1-2 study of the safety of GC4711, and its potential to reduce radiation-related pulmonary injury due to SBRT for early stage large or central localized NSCLC. After an open-label, Phase 1, safety cohort of approximately 5 subjects has been completed, a randomized, double-blind, placebo-controlled Phase 2 portion will be conducted. | ||||||||
Detailed Description | Subjects must be referred for SBRT with large (>3cm) or central localized, node negative, non-metastatic NSCLC, and have an ECOG PS score of 0-3 to be considered for enrollment. Subjects with small peripheral lesions(≤3cm) are excluded, as the aim is to improve outcome in larger, central NSCLC carrying a higher risk of pneumonitis, as well as poorer local control. Feasibility of SBRT is judged by the treating physician. Chemotherapy given before SBRT is permitted, but subjects must be immunotherapy naive. SBRT is planned on the (persistent) PET+ tumor location for a dose of 10-12 Gy in 5 fractions, delivered on sequential weekdays. In the Phase 1, 5 subjects will each receive GC4711 by 15-minute IV infusion, before each SBRT fraction After the Phase 1, a Phase 2, randomized, double-blind, placebo-controlled study phase will be initiated, wherein approximately 66 subjects referred for SBRT with early stage large or central localized NSCLC will be randomized in a 1:1 ratio to receive either GC4711 or placebo given intravenously (IV) before each fraction of SBRT. All subjects will be evaluated for changes in the diffusion capacity of carbon monoxide (DLCO) and pneumonitis. All subjects will be followed for 12 months for treatment related adverse effects, disease control (Progression Free Survival (PFS), Overall Survival (OS), Distant Metastases (DM) rate and local control-(RECSIST 1.1), and quality of life (FACT-L) A Data Monitoring Committee will be established for the Phase 2 portion of the study to provide independent monitoring of safety given the blinded design. |
||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 Phase 2 |
||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||
Condition ICMJE |
|
||||||||
Intervention ICMJE |
|
||||||||
Study Arms ICMJE |
|
||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
71 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | July 2023 | ||||||||
Estimated Primary Completion Date | November 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Sex/Gender ICMJE |
|
||||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
|
||||||||
Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04476797 | ||||||||
Other Study ID Numbers ICMJE | GTI-4711-101 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
|
||||||||
IPD Sharing Statement ICMJE |
|
||||||||
Responsible Party | Galera Therapeutics, Inc. | ||||||||
Study Sponsor ICMJE | Galera Therapeutics, Inc. | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
|
||||||||
PRS Account | Galera Therapeutics, Inc. | ||||||||
Verification Date | March 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |