GC4711 + SBRT for Non-Small Cell Lung Cancer

(GRECO-1 Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Galera Therapeutics, Inc.

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion 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.

Treatment Details

Interventions

• GC4711 (Radiosensitizer)
• Placebo (Chemotherapy)

Participant Groups

Group I: Phase 2 GC4711 +SBRT Experimental Treatment 1 Intervention

Group II: Phase 1 GC4711 + SBRT Experimental Treatment 1 Intervention

Group III: Phase 2 Placebo + SBRT Placebo Group 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Who Is Running the Clinical Trial?

Galera Therapeutics, Inc. Lead Sponsor

References