NCT05267470

A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201)

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Bemarituzumab Monotherapy and Combination With Other Anti-Cancer Therapy in Subjects With Squamous-Cell Non-Small-Cell Lung Cancer (FORTITUDE-201)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to evaluate the safety and tolerability of bemarituzumab monotherapy and combination with other anti-cancer therapies, and to determine the recommended phase 3 dose of bemarituzumab in combination with other anti-cancer therapies.

Conditions

• Squamous-Cell Non-Small-Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Bemarituzumab	Intravenous (IV) infusion
DRUG	Docetaxel	IV infusion
DRUG	Pembrolizumab	IV infusion
DRUG	Carboplatin	IV infusion
DRUG	Paclitaxel	IV infusion
DRUG	Nab-paclitaxel	IV infusion

Timeline

• Start date: 2022-03-29
• Primary completion: 2024-05-28
• Completion: 2024-05-28
• First posted: 2022-03-04
• Last updated: 2025-03-25
• Results posted: 2025-03-25

Locations

39 sites across 8 countries: United States, Belgium, France, Japan, Poland, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study