NCT04758949

FL-101 in Surgically Resectable Non-Small Cell Lung Cancer

A Two-cohort, Phase 2 Study of FL-101 as Neoadjuvant Therapy in Patients With Surgically Resectable Non-Small Cell Lung Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Flame Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 2 trial to study FL-101 alone or in combination with nivolumab in patients who have surgically resectable Non-Small Cell Lung Cancer.

Detailed description

A 2-Cohort, Phase 2, multicenter, parallel-design trial that will study patients with surgically resectable, stages I-IIIA, non-small cell lung cancer (NSCLC) . The clinical study will focus on whether FL-101 has direct anti-tumor activity when given alone prior to surgery, and if FL-101 improves the anti-tumor response when given in combination with nivolumab prior to surgery.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	FL-101	200 mg administered intravenously every 2 weeks prior to surgery.
DRUG	Nivolumab	240 mg administered intravenously every 2 weeks prior to surgery.
DRUG	Placebo	200 mg administered intravenously every 2 weeks prior to surgery.

Timeline

• Start date: 2021-08-25
• Primary completion: 2021-12-22
• Completion: 2021-12-22
• First posted: 2021-02-17
• Last updated: 2022-01-11

Regulatory

• FDA-regulated drug study