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Monoclonal Antibodies
Bemarituzumab Combination Therapy for Squamous Cell Lung Cancer (FORTITUDE-201 Trial)
Phase 1
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Disease that is unresectable, locally advanced or metastatic (not amenable to curative therapy)
Pathologically confirmed squamous cell lung carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights
FORTITUDE-201 Trial Summary
This trial is testing a new cancer drug to see if it is safe and effective.
Who is the study for?
This trial is for adults with a specific lung cancer type (SqNSCLC) that can't be removed by surgery or has spread, and shows high levels of FGFR2b protein. Participants must have tried at least one systemic therapy before, unless they're in Part 4 where no prior treatment for advanced disease is allowed. They need good organ function and an ECOG status of 0 or 1, meaning they are fully active or restricted in physically strenuous activity but can do light work.Check my eligibility
What is being tested?
The study tests Bemarituzumab alone and combined with other anti-cancer drugs like Docetaxel, Pembrolizumab, Carboplatin, Paclitaxel, Nab-paclitaxel to find the safest dose for phase 3 trials. It's checking how well patients tolerate these treatments and what effects they have on this type of lung cancer.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in different body parts; eye issues like corneal defects; heart problems including unstable angina or uncontrolled hypertension; blood pressure changes; fatigue; digestive disturbances; skin reactions; and increased risk of infections.
FORTITUDE-201 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition cannot be cured with surgery.
Select...
My lung cancer is confirmed to be squamous cell type.
Select...
I am at least 18 years old or considered an adult in my country.
Select...
I am fully active or can carry out light work.
FORTITUDE-201 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 and 4: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
Parts 1, 2, 3 and 4: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Secondary outcome measures
Parts 1, 2, 3 and 4: Area Under the Concentration Time Curve (AUC) of Bemarituzumab
Parts 1, 2, 3 and 4: Disease Control Rate
Parts 1, 2, 3 and 4: Duration of Response
+5 moreSide effects data
From 2020 Phase 2 trial • 80 Patients • NCT0221328994%
Fatigue
85%
Neuropathy-sensory
76%
Nausea
63%
Diarrhea
60%
Anorexia
54%
Abdominal pain
47%
Constipation
46%
Vomiting
40%
Dysphagia, esophagitis, odynophagia
38%
Dysgeusia
31%
Weight loss
29%
Pain
29%
Edema limbs
29%
Back pain
29%
Anemia
28%
Paresthesia
25%
Dyspnea
25%
Fever
24%
Cough
21%
Dizzines
21%
Platelet count decreases
19%
Gastroesophagial reflux disease
19%
Mucositis oral
15%
Headache
15%
Epistaxis
15%
Hypertension
15%
Mood aleration - depression
13%
Thromboembolic event
13%
Hypokalemia
12%
Rash acneiform
12%
Pleural effusion
12%
Ascites
12%
Insomnia
12%
Neutrophil count decreased
12%
Non-cardiac chest pain
10%
Alopecia
10%
Generalized muscle weakness
10%
Bloating
10%
Blood bilirubin increased
10%
Hypotension
9%
Pain in extremity
9%
Palmar-plantar erythrodysesthesia synrome
9%
Chills
9%
General disorders and administration site conditions - Other
9%
Localized edema
9%
Rash maculo-papular
7%
Dyspepsia/heartburn
7%
Sepsis
7%
Nasal congestion
7%
Neck pain
7%
Arthralgia
7%
Colitis
7%
Fall
6%
Dysphagia
6%
Aspiration
6%
Hematuria
6%
Sore throat
6%
Upper respiratory infection
6%
Urinary track infection
6%
Aspartate aminotransferase increased
6%
Dry skin
6%
Flank pain
6%
Gastrointestinal disorders - Other
6%
Hypoxia
6%
Proteinuria
6%
Abdominal distenstion
4%
Chest pain - cardiac
4%
Alanine aminotransferase increased
4%
Urinary incontinence
3%
Stroke
3%
Hyperkalemia
3%
Tremor
3%
Sinusitis
3%
Periodontal disease
3%
Urinary tract obstruction
3%
Urinary tract infection
3%
Bruising
3%
Febrile neutropenia
3%
Leukocytosis
3%
Pneumonitis
1%
Pelvic infection
1%
Esophageal obstruction
1%
Esophagitis
1%
Gastroparesis
1%
Small intestinal obstruction
1%
Blood and lymphatic system disorders - Other
1%
Death NOS
1%
Seizure
1%
Blurred vision
1%
Platelet count decreased
1%
Catheter related infection
1%
Dehydration
1%
Delirium
1%
Phlebitis infective
1%
Renal and urinary disorders - Other
1%
Surgical and medical procedures - Other
1%
Syncope
1%
Upper gastrointestinal hemorrhage
1%
Flu like symptoms
1%
Fracture
1%
Gastrointestinal pain
1%
hemorrhoidal hemorrhage
1%
Musculoskeletal and connective tissue disorder - Other
1%
Presyncope
1%
Renal colic
1%
Esophageal perforation
100%
80%
60%
40%
20%
0%
Study treatment Arm
ITT-PTS: Personalized Treatment Strategy
Non-ITT: Standard Therapy
FORTITUDE-201 Trial Design
4Treatment groups
Experimental Treatment
Group I: Part 4: Combination Immuno-chemotherapyExperimental Treatment5 Interventions
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.
Group II: Part 3: Bemarituzumab MonotherapyExperimental Treatment1 Intervention
Participants with SqNSCLC and FGFR2b overexpression will receive bemarituzumab monotherapy.
Group III: Part 2: Combination Dose ExpansionExperimental Treatment2 Interventions
Participants with SqNSCLC and FGFR2b overexpression will receive the dose of bemarituzumab in combination with docetaxel identified as safe during Part 1.
Group IV: Part 1: Combination Dose ExplorationExperimental Treatment2 Interventions
Participants with SqNSCLC will receive escalating doses of bemarituzumab in combination with docetaxel.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bemarituzumab
2018
Completed Phase 2
~250
Docetaxel
1995
Completed Phase 4
~5620
Pembrolizumab
2017
Completed Phase 2
~2010
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380
Nab-paclitaxel
2014
Completed Phase 3
~2030
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,508 Total Patients Enrolled
MDStudy DirectorAmgen
913 Previous Clinical Trials
923,951 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are working well.I have a tumor tissue sample from the last 5 years or am willing to provide one.I haven't had systemic therapy for my advanced or metastatic disease yet.I have had at least one (or two for Part 3) treatments for my advanced cancer, including platinum-based chemotherapy and a checkpoint inhibitor.My cancer shows high levels of FGFR2b protein.My cancer got worse after treatment with docetaxel.I have had docetaxel for advanced cancer but not as an early treatment that didn't progress quickly.I have serious heart issues, including recent heart attacks or uncontrolled blood pressure.I had to stop taking docetaxel due to severe side effects or allergic reactions.I haven't had eye surgery or laser treatment, nor do I have corneal issues, in the last 6 months.You have a tumor that can be measured using specific guidelines.My condition cannot be cured with surgery.I have been treated with drugs targeting the FGF-FGFR pathway.My lung cancer is confirmed to be squamous cell type.My lung cancer is a mix of small-cell and non-small cell types.I am at least 18 years old or considered an adult in my country.I have brain metastases or leptomeningeal disease that hasn't been treated or is causing symptoms.I have recent or worsening eye problems.I am fully active or can carry out light work.I need frequent procedures to remove fluid buildup more than once a month.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2: Combination Dose Expansion
- Group 2: Part 3: Bemarituzumab Monotherapy
- Group 3: Part 4: Combination Immuno-chemotherapy
- Group 4: Part 1: Combination Dose Exploration
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the criteria for joining this experiment?
"This clinical trial is seeking 108 patients diagnosed with non-small cell lung carcinoma aged between 18 and 99. In order to be eligible, the patient must meet several criteria: they must provide informed consent/assent before any study activities can commence, have a specimen of tumor tissue taken within 5 years or agree to undergo pre-treatment biopsy; demonstrate measurable disease as per RECIST v1.1 criteria; fall into an age bracket of at least 18 (or legal adult in their country); present pathologically confirmed squamous cell lung carcinoma; possess unresectable locally advanced or metastatic disease that has progressed after 1 line of"
Answered by AI
What is the scope of participants for this clinical experiment?
"Correct. The clinicaltrials.gov database indicates that this medical investigation, which was first advertised on March 29th 2022, is currently seeking volunteers. Approximately 108 individuals must be recruited from 3 sites."
Answered by AI
What have been the results of studies involving Bemarituzumab and its effects on human health?
"Since this is a first-phase trial, the safety of Bemarituzumab was given a score of 1 due to our team's assessment based on limited efficacy data."
Answered by AI
Are those aged 18 or above eligible to join the experiment?
"The enrolment window for this trial ranges from 18 to 99 years old."
Answered by AI
Are there still opportunities for individuals to join this experimental research?
"Affirmative. According to the information sourced from clinicaltrials.gov, this experiment is actively seeking participants since its original listing on March 29th 2022 and was last revised on October 26th 2022. This trial aims to enrol 108 individuals across three research facilities."
Answered by AI
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