Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis Due to Chemoradiotherapy for Lung Cancer

Phase 2

Terminated

• Conditions: Esophagitis
• Interventions: Drug: GC4419 (avasopasem manganese)

• Registration Number: NCT04225026
• Lead Sponsor: Galera Therapeutics, Inc.

Brief Summary

GTI-4419-203 will be an open-label, multi-center study to evaluate GC4419 (avasopasem manganese) administered intravenous (IV) for the reduction of radiation induced esophagitis in subjects receiving chemoradiotherapy for unresectable Stage 3A/3B or post-operative Stage 2B Non-Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) treatable with chemoradiotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-19
• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Primary Completion: 2021-12-28
• Study Completion: 2022-03-27
• Status Verified: 2022-06
• Results First Submitted: 2022-11-17
• Results First Submitted QC: 2023-03-22
• Last Update Submitted: 2023-03-22
• Results First Posted: 2023-03-23
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

1. Subjects scheduled to be treated with (definitive or adjuvant) radiation therapy in combination with chemotherapy once daily for Stage 3A/3B or post-operative Stage 2B NSCLC or limited stage SCLC
2. Treatment plan for subjects show that 5 cm of the esophagus for at least one surface, is included in the 60 Gy isodose volume. Dose volume histograms show esophagus dose exposure meet V38>30% and/or V60>20%
3. Age 18 years or older
4. ECOG performance status ≤ 2
5. Adequate hematologic, renal and liver function
6. Use of highly effective contraception

Exclusion Criteria

1. Metastatic disease
2. Prior radiation therapy to the region of the study cancer
3. Subjects not receiving chemotherapy
4. Grade 2 or greater esophagitis at baseline
5. Inability to provide information in the electronic symptom-reporting device
6. Receiving any approved or investigational immunotherapy, targeted therapy, hormone therapy, or biologic therapy
7. Participation in another clinical trial or use of another investigational agent within 30 days of first does of GC4419
8. Malignant tumors other than the current lung cancer within the last 5 years
9. Previous diagnosis of pneumonitis
10. Untreated, active infectious disease requiring systemic anti-infective therapy
11. Untreated HIV or active hepatitis B/C
12. Females who are pregnant or breastfeeding
13. Known allergies or intolerance to chemotherapy and similar platinum-containing compounds
14. Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure
15. Clinically significant heart disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GC4419 (avasopasem manganese)	GC4419 (avasopasem manganese)	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects With of Acute Radiation Esophagitis (Defined as Grade >/= 2; NCI CTCAE Version 5) Through the End of Chemoradiotherapy for Non-Small Cell Lung (NSCLC) or Small Cell Lung Cancer (SCLC) When Avasopasem Was Added.	From the first radiation therapy fraction through the end of the study treatment period, which is estimated to be 6 weeks.	Those subjects in the primary efficacy population that experience acute radiation esophagitis (Grade \>/=2; NCI CTCAE version 5) through the end of chemoradiotherapy for NSCLC or SCLC when treated with avasopasem.; NCI CTCAE Grading: Grade 1: asymptomatic; clinical or diagnostic observations only; intervention not indicated Grade 2: symptomatic; altered eating/swallowing; oral supplements indicated Grade 3: severely altered eating/swallowing; tube feeding, total parental nutrition (TPN) or hospitalization Grade 4: life-threatening consequences; urgent operative intervention indicated Grade 5: death

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With of Acute Radiation Esophagitis (Defined as Grade >/= 2; NCI CTCAE Version 5) Through 4 Weeks After Completion of Chemoradiotherapy	From the first radiation therapy fraction through 4 weeks after the completion of chemoradiotherapy, which is estimated to be 10 weeks	Those subjects in the in the primary efficacy population that experience Grade \>/= 2 (NCI CTCAE version 5) acute radiation esophagitis through 4 weeks after completion of chemoradiotherapy for NSCLC or SCLC when treated with avasopasem.; NCI CTCAE Grading: Grade 1: asymptomatic; clinical or diagnostic observations only; intervention not indicated Grade 2: symptomatic; altered eating/swallowing; oral supplements indicated Grade 3: severely altered eating/swallowing; tube feeding, total parental nutrition (TPN) or hospitalization Grade 4: life-threatening consequences; urgent operative intervention indicated Grade 5: death
Number of Subjects With Acute Severe Radiation Esophagitis (Defined as Grade 3-4; NCI CTCAE Version 5) Through Completion of Chemoradiotherapy.	From the first radiation therapy fraction through the completion of chemoradiotherapy, which is estimated to be 6 weeks.	Those subjects in the per protocol population that experienced Grade 3-4 acute radiation esophagitis through the completion of chemoradiotherapy.; NCI CTCAE Grading: Grade 1: asymptomatic; clinical or diagnostic observations only; intervention not indicated; Grade 2: symptomatic; altered eating/swallowing; oral supplements indicated; Grade 3: severely altered eating/swallowing; tube feeding, total parental nutrition (TPN) or hospitalization; Grade 4: life-threatening consequences; urgent operative intervention indicated; Grade 5: Death.

Trial Locations

Locations (12)

Cancer Care St. Joseph/Mosaic Life Care; 🇺🇸 Saint Joseph, Missouri, United States

IACT Health; 🇺🇸 Columbus, Georgia, United States

St. Francis Hospital; 🇺🇸 Greenville, South Carolina, United States

University of Tennessee Medical Center; 🇺🇸 Knoxville, Tennessee, United States

Providence Regional Cancer Partnership; 🇺🇸 Everett, Washington, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Banner MD Anderson Cancer Center; 🇺🇸 Gilbert, Arizona, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

Spartanburg Regional Medical Center - Gibbs Cancer Center; 🇺🇸 Spartanburg, South Carolina, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Hackensack Meridian Health; 🇺🇸 Montclair, New Jersey, United States