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

Part of paid clinical trials in Orange, California.

Sponsor
Amgen
Study ID
NCT05267470
Phase
PHASE1
Status
Terminated

Conditions

  • Squamous-Cell Non-Small-Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Bemarituzumab — DRUG
    Intravenous (IV) infusion
  • Docetaxel — DRUG
    IV infusion
  • Pembrolizumab — DRUG
    IV infusion
  • Carboplatin — DRUG
    IV infusion
  • Paclitaxel — DRUG
    IV infusion
  • Nab-paclitaxel — DRUG
    IV infusion

Study Details

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.

Key Dates

First listed
Mar 4, 2022
Start date
Mar 29, 2022
Status verified
Feb 2025
Primary completion
May 28, 2024
Completion
May 28, 2024

Study Design

Enrollment
74 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Combination Dose Exploration
    Participants with SqNSCLC will receive escalating doses of bemarituzumab in combination with docetaxel.
  • Experimental: Part 2: Combination Dose Expansion
    Participants with SqNSCLC and FGFR2b overexpression will receive the dose of bemarituzumab in combination with docetaxel identified as safe during Part 1.
  • Experimental: Part 3: Bemarituzumab Monotherapy
    Participants with SqNSCLC and FGFR2b overexpression will receive bemarituzumab monotherapy.
  • Experimental: Part 4: Combination Immuno-chemotherapy
    Participants with FGFR2b overexpression will receive the dose of bemarituzumab identified as safe during Part 1 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel.

Primary Outcome Measure

Number of Participants Who Experienced a Dose Limiting Toxicity (DLT): Parts 1 and 4 [ Time Frame: Day 1 to Day 21 of Cycle 1 (each cycle was 21 days) ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of California IrvineOrangeCalifornia92868-
Morristown Medical CenterMorristownNew Jersey07960-
Montefiore Einstein Center for Cancer CareThe BronxNew York10461-
University of Pittsburgh, Cancer InstitutePittsburghPennsylvania15211-

Related coverage on Hipa.ai

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By research site
University of California Irvine· Orange, CAMorristown Medical Center· Morristown, NJMontefiore Einstein Center for Cancer Care· The Bronx, NYUniversity of Pittsburgh, Cancer Institute· Pittsburgh, PA