Poziotinib for Carcinoma, Non-Small-Cell Lung

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Bond Clinic, P.A., Winter Haven, FL
Carcinoma, Non-Small-Cell Lung+1 More
Poziotinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The primary purpose of this study is to compare the progression-free survival (PFS) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring human epidermal growth factor receptor 2 (HER2) exon 20 mutations when treated with poziotinib versus docetaxel.

Eligible Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Carcinoma, Non-Small-Cell Lung

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to approximately 5 years

Year 5
Disease Control Rate (DCR)
Objective Response Rate (ORR)
Overall survival (OS)
Progression Free Survival (PFS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Carcinoma, Non-Small-Cell Lung

Side Effects for

Cohort 1: Poziotinib 24 mg
91%Diarrhoea
61%Rash
55%Fatigue
48%Stomatitis
48%Vomiting
39%Decreased Appetite
36%Nausea
33%Dry skin
24%Dermatitis acneiform
24%Mucosal inflammation
21%Urinary tract infection
21%Hypokalaemia
18%Alopecia
18%Dizziness
18%Weight decreased
15%Constipation
15%Headache
15%Anaemia
15%Epistaxis
15%Dehydration
12%Anxiety
12%Pyrexia
12%Blood creatinine increased
12%Cough
12%Oropharyngeal pain
12%Pain
12%Paronychia
12%Arthralgia
12%Oedema peripheral
12%Aspartate aminotransferase increased
12%Dyspnoea
12%Musculoskeletal pain
9%Burning sensation
9%Blood alkaline phosphatase increased
9%Pleural effusion
9%Pruritus
9%Agitation
9%Dysgeusia
9%Conjunctivitis
9%Blood potassium decreased
9%Rash maculo-papular
9%Alanine aminotransferase increased
9%Hypomagnesaemia
6%Somnolence
6%Muscular weakness
6%Erythema
6%Abdominal pain upper
6%Chills
6%Blood uric acid increased
6%Rhinorrhoea
6%Rash macular
6%Dry eye
6%Hypertension
6%Cellulitis
6%Cheilitis
6%Urinary incontinence
6%Dysuria
6%Pruritus generalised
6%Dry mouth
6%Fungal infection
6%Vulvovaginal discomfort
6%Palmar-plantar erythrodysaesthesia syndrome
6%Asthenia
6%Vulvovaginal mycotic infection
6%Thrombocytopenia
6%Eye discharge
6%Pericardial effusion
6%Abdominal distension
6%Myalgia
6%Hyponatraemia
6%Skin lesion
3%Soft tissue infection
3%Nasal congestion
3%Influenza like illness
3%Oral pain
3%Localised infection
3%Balance disorder
3%Flatulence
3%Blood urea increased
3%Skin lesion excision
3%Lymphocyte count decreased
3%Upper respiratory tract infection
3%Nasal dryness
3%Tinea pedis
3%Haematocrit decreased
3%Throat irritation
3%Sinusitis
3%Hypothyroidism
3%Ear infection
3%Herpes zoster
3%Femur fracture
3%Gingival pain
3%Oral candidiasis
3%Oedema
3%Candida infection
3%Blood bilirubin increased
3%Neuropathy peripheral
3%Insomnia
3%Rash erythematous
3%Rash generalised
3%Lymphoedema
3%Delirium
3%Sinus congestion
3%Glossodynia
3%Urticaria
3%Nail injury
3%Procedural pain
3%Perineal pain
3%Respiratory tract congestion
3%Hiccups
3%Spinal cord compression
3%Dysphagia
3%Gastritis
3%Ophthalmic herpes zoster
3%Neutrophil count decreased
3%Haemoglobin decreased
3%Vulvovaginal inflammation
3%Breast pain
3%Platelet count decreased
3%Ear pain
3%Gait disturbance
3%Dermatitis bullous
3%Skin disorder
3%Eye irritation
3%Vitreous floaters
3%Blood calcium decreased
3%Fall
3%Scapula fracture
3%Glomerular filtration rate decreased
3%Back pain
3%Syncope
3%Skin irritation
3%Gastrooesophageal reflux disease
3%Neutrophil count increased
3%Irritability
3%Dysphonia
3%Angular cheilitis
3%Skin candida
3%Oral discomfort
3%Mouth ulceration
3%Ocular hyperaemia
3%Rash pustular
3%White blood cell count increased
3%Glomerular filtration rate increased
3%Breast cancer
3%Depression
3%Pleuritic pain
3%Hypotension
3%Multiple organ dysfunction syndrome
3%Cystitis
3%Cardio-respiratory arrest
3%Pneumonia
3%Liver function test abnormal
3%Blood magnesium decreased
3%Vulvovaginal burning sensation
3%Paranasal sinus discomfort
3%Lip oedema
3%Proctalgia
3%Acute respiratory failure
3%Haemorrhage intracranial
3%Respiratory failure
3%Eye swelling
3%Lymphopenia
3%Cataract
3%Musculoskeletal chest pain
3%Hyperphosphataemia
3%Acidosis
3%Bone pain
3%Musculoskeletal stiffness
3%Hypercalcaemia
3%Pain in extremity
3%Hypophosphataemia
0%Tenderness
0%Sensory disturbance
0%Compression fracture
0%Ejection fraction decreased
0%Skin ulcer
0%Tongue fungal infection
0%Neuralgia
0%Flank pain
0%Periorbital oedema
0%Anal incontinence
0%Acute kidney injury
0%Enterocolitis infection
0%Skeletal injury
0%Purpura
0%Clostridium difficile infection
0%Vertigo
0%Bacteraemia
0%Abdominal pain
0%Hydronephrosis
0%Skin abrasion
0%Spinal pain
0%Nephrolithiasis
0%Dyspnoea exertional
0%Koilonychia
0%Rash pruritic
0%Dyskinesia
0%Groin infection
0%Rhinitis
0%Blood chloride decreased
0%Fungal skin infection
0%Contusion
0%Gamma-glutamyltransferase increased
0%Confusional state
0%Vulvovaginal dryness
0%Onychoclasis
0%Dysarthria
0%Nail infection
0%Wound infection
0%Infusion site rash
0%Haematuria
0%Monocyte count increased
0%Blood phosphorus decreased
0%Hirsutism
0%Face oedema
0%Nasal discomfort
0%Rectal haemorrhage
0%Localised oedema
0%Conjunctival haemorrhage
0%Lacrimation increased
0%Atrial fibrillation
0%Proctitis
0%Skin infection
0%Neck pain
0%Muscle spasms
0%Memory impairment
0%Onychomadesis
0%Otorrhoea
0%Vaginal discharge
0%Laryngeal inflammation
0%Acne
0%Abdominal discomfort
0%Dyspepsia
0%Anal inflammation
0%Enterocolitis infectious
0%Fractured sacrum
0%Tachycardia
0%Diplopia
0%Leukocytosis
0%Seizure like phenomena
0%Ventricular tachycardia
0%Ear discomfort
0%Hyperglycaemia
0%Hyperuricaemia
0%Hypoalbuminaemia
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT02659514) in the Cohort 1: Poziotinib 24 mg ARM group. Side effects include: Diarrhoea with 91%, Rash with 61%, Fatigue with 55%, Stomatitis with 48%, Vomiting with 48%.

Trial Design

3 Treatment Groups

Docetaxel 75 mg/m^2
1 of 3
Poziotinib 8 mg
1 of 3
Poziotinib 16 mg
1 of 3
Active Control
Experimental Treatment

268 Total Participants · 3 Treatment Groups

Primary Treatment: Poziotinib · No Placebo Group · Phase 3

Poziotinib 8 mg
Drug
Experimental Group · 1 Intervention: Poziotinib · Intervention Types: Drug
Poziotinib 16 mg
Drug
Experimental Group · 1 Intervention: Poziotinib · Intervention Types: Drug
Docetaxel 75 mg/m^2
Drug
ActiveComparator Group · 1 Intervention: Docetaxel · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Poziotinib
2016
Completed Phase 2
~340

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 5 years
Closest Location: Bond Clinic, P.A. · Winter Haven, FL
Photo of florida 1Photo of florida 2Photo of florida 3
2018First Recorded Clinical Trial
2 TrialsResearching Carcinoma, Non-Small-Cell Lung
4 CompletedClinical Trials

Who is running the clinical trial?

Spectrum Pharmaceuticals, IncLead Sponsor
82 Previous Clinical Trials
7,885 Total Patients Enrolled
9 Trials studying Carcinoma, Non-Small-Cell Lung
994 Patients Enrolled for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have histologically or cytologically confirmed non-small cell lung cancer.
You have had at least one prior systemic treatment for locally advanced or metastatic NSCLC, including platinum and a checkpoint inhibitor (CPI) therapy, unless the investigator affirms that a CPI was not medically indicated.
You have an ECOG PS of 0 or 1.
You have adequate hematologic, hepatic, and renal function at Baseline as per protocol.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.