What side effects are associated with this type of intervention?

Common treatments for Squamous Cell Carcinoma (SqNSCLC) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy agents like cisplatin and paclitaxel can cause side effects such as nausea, vomiting, hair loss, and increased risk of infection. Targeted therapies, including monoclonal antibodies like cetuximab (targeting EGFR), can lead to skin rashes, diarrhea, and infusion reactions. Immunotherapy agents, such as pembrolizumab, may cause fatigue, skin reactions, and immune-related adverse effects like colitis and pneumonitis. Bemarituzumab, a monoclonal antibody targeting FGFR2b, is being studied for its safety and tolerability, with potential side effects similar to other monoclonal antibodies, including infusion reactions and gastrointestinal disturbances.

What prior FDA approvals exist?

FDA-approved treatments for Squamous Cell Carcinoma (SCC) include cetuximab, a monoclonal antibody targeting the epidermal growth factor receptor (EGFR). Cetuximab has been shown to improve overall survival and progression-free survival when combined with chemotherapy in recurrent or metastatic head and neck SCC. Other targeted therapies, such as pembrolizumab and nivolumab, which are immune checkpoint inhibitors targeting PD-1, have also been approved for SCC, particularly in cases where the disease has progressed after chemotherapy. These treatments are somewhat analogous to bemarituzumab, which targets FGFR2b, as they all involve monoclonal antibodies designed to target specific pathways involved in cancer growth.

What other types of research exist?

Promising alternatives to Bemarituzumab for SqNSCLC patients include Pembrolizumab (an anti-PD-1 monoclonal antibody), Atezolizumab (an anti-PD-L1 monoclonal antibody), and Ramucirumab (an anti-VEGFR2 monoclonal antibody). These agents have shown efficacy in clinical trials and are being evaluated for their potential in treating SqNSCLC.

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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

Must not have

Impaired cardiac function or clinically significant cardiac disease including: unstable angina within 6 months prior to first dose of study treatment, acute myocardial infarction < 6 months prior to first dose of study treatment, New York Heart Association (NYHA) class II-IV congestive heart failure, uncontrolled hypertension (defined as an average systolic blood pressure >160 mmHg or diastolic >100 mm Hg despite optimal treatment (measured following European Society for Hypertension/European Society of Cardiology [ESH/ESC] 2013 guidelines; Section 11.11), uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, active coronary artery disease, Fridericia's correction formula (QTc) ≥ 470

Part 1 and Part 2: participants that experienced toxicity or hypersensitivity requiring discontinuation of prior docetaxel treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 1 day 1 to 28 days after last dose (approximately 5 months; cycle is 21 days in parts 1 and 2, cycle is 14 days in part 3)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests bemarituzumab, a cancer treatment, alone or with other therapies. It aims to check its safety in cancer patients and find the best dose. Bemarituzumab works by attaching to cancer cells and blocking their growth.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition cannot be cured with surgery.

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My lung cancer is confirmed to be squamous cell type.

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I am at least 18 years old or considered an adult in my country.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have serious heart issues, including recent heart attacks or uncontrolled blood pressure.

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I had to stop taking docetaxel due to severe side effects or allergic reactions.

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I haven't had eye surgery or laser treatment, nor do I have corneal issues, in the last 6 months.

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I have been treated with drugs targeting the FGF-FGFR pathway.

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My lung cancer is a mix of small-cell and non-small cell types.

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I have brain metastases or leptomeningeal disease that hasn't been treated or is causing symptoms.

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I need frequent procedures to remove fluid buildup more than once a month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 1 day 1 to 28 days after last dose (approximately 5 months; cycle is 21 days in parts 1 and 2, cycle is 14 days in part 3)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 1 day 1 to 28 days after last dose (approximately 5 months; cycle is 21 days in parts 1 and 2, cycle is 14 days in part 3)

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day 1 to 28 days after last dose (approximately 5 months; cycle is 21 days in parts 1 and 2, cycle is 14 days in part 3) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Parts 1, 2, 3 and 4: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)

Side effects data

From 2020 Phase 2 trial • 80 Patients • NCT02213289

94%

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%

Edema limbs

29%

Pain

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

Palmar-plantar erythrodysesthesia synrome

Pain in extremity

Chills

General disorders and administration site conditions - Other

Localized edema

Rash maculo-papular

Sepsis

Dyspepsia/heartburn

Nasal congestion

Neck pain

Arthralgia

Colitis

Fall

Hematuria

Aspiration

Dysphagia

Sore throat

Upper respiratory infection

Urinary track infection

Aspartate aminotransferase increased

Dry skin

Flank pain

Gastrointestinal disorders - Other

Hypoxia

Proteinuria

Abdominal distenstion

Chest pain - cardiac

Alanine aminotransferase increased

Urinary incontinence

Stroke

Hyperkalemia

Tremor

Sinusitis

Periodontal disease

Urinary tract obstruction

Urinary tract infection

Bruising

Febrile neutropenia

Leukocytosis

Pneumonitis

Gastroparesis

Pelvic infection

Esophageal obstruction

Esophagitis

Small intestinal obstruction

Blood and lymphatic system disorders - Other

Death NOS

Seizure

Blurred vision

Platelet count decreased

Catheter related infection

Dehydration

Delirium

Phlebitis infective

Renal and urinary disorders - Other

Surgical and medical procedures - Other

Syncope

Upper gastrointestinal hemorrhage

Flu like symptoms

Fracture

Gastrointestinal pain

hemorrhoidal hemorrhage

Musculoskeletal and connective tissue disorder - Other

Presyncope

Renal colic

Esophageal perforation

100%

80%

60%

40%

20%

Study treatment Arm

ITT-PTS: Personalized Treatment Strategy

Non-ITT: Standard Therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~6550

Pembrolizumab

2017

Completed Phase 3

~3150

Carboplatin

2014

Completed Phase 3

~6120

Paclitaxel

2011

Completed Phase 4

~5450

Nab-paclitaxel

2014

Completed Phase 3

~1950

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Squamous Cell Carcinoma (SqCC) include chemotherapy, radiation therapy, and targeted therapies. Chemotherapy works by killing rapidly dividing cells, while radiation therapy uses high-energy rays to destroy cancer cells. Targeted therapies, such as monoclonal antibodies, specifically target cancer cell proteins to inhibit their growth. Bemarituzumab, a monoclonal antibody targeting FGFR2b, is an example of a targeted therapy being studied for its potential to block the FGFR2b pathway, which is involved in tumor growth and survival. Understanding these mechanisms is crucial for SqCC patients as it helps in selecting the most effective treatment, potentially leading to better outcomes and fewer side effects.

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