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

NCT05267470 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-03-25

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-29
Primary Completion
2024-05-28
Completion
2024-05-28
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Japan
  • Poland
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05267470 on ClinicalTrials.gov