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FL-101 for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Research Sponsored by Flame Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of surgery (around 6-8 weeks after first dose)
Awards & highlights

Summary

Phase 2 trial to study FL-101 alone or in combination with nivolumab in patients who have surgically resectable Non-Small Cell Lung Cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of surgery (around 6-8 weeks after first dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of surgery (around 6-8 weeks after first dose) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients with treatment related adverse events as assessed by NCI CTCAE v.5.0
Secondary study objectives
Complete Pathologic Response
MRD measurement by ctDNA
Major Pathologic Response
+2 more
Other study objectives
Plasma Concentration of FL-101
Plasma IL-1β/IL-6 levels
Prevalence and incidence of Anti-FL-101 antibodies
+1 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Cushingoid
10%
Tinnitus
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: FL-101 MonotherapyExperimental Treatment1 Intervention
30 patients will receive FL-101 prior to surgery.
Group II: FL-101 + NivolumabExperimental Treatment2 Interventions
30 patients will receive FL-101 and Nivolumab prior to surgery.
Group III: Nivolumab + PlaceboActive Control2 Interventions
30 patients will receive Nivolumab and placebo prior to surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5220

Find a Location

Who is running the clinical trial?

Flame BiosciencesLead Sponsor
3 Previous Clinical Trials
24 Total Patients Enrolled
Steven Fischkoff, MDStudy DirectorFlame Biosciences
1 Previous Clinical Trials
21 Total Patients Enrolled
Cassandra Choe-Juliak, MDStudy DirectorFlame Biosciences
1 Previous Clinical Trials
~0 spots leftby Sep 2025
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