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Cytotoxic Agent

Poziotinib for Non-Small Cell Lung Cancer (PINNACLE Trial)

Phase 3
Waitlist Available
Research Sponsored by Spectrum Pharmaceuticals, Inc
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 up to approximately 5 years
Awards & highlights

PINNACLE Trial Summary

This trial will compare the effects of two drugs on lung cancer patients with HER2 exon 20 mutations.

Eligible Conditions
  • Non-Small Cell Lung Cancer

PINNACLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Disease Control Rate (DCR)
Objective Response Rate (ORR)
Overall survival (OS)

Side effects data

From 2020 Phase 2 trial • 67 Patients • NCT02659514
91%
Diarrhoea
61%
Rash
55%
Fatigue
48%
Stomatitis
48%
Vomiting
39%
Decreased Appetite
36%
Nausea
33%
Dry skin
24%
Mucosal inflammation
24%
Dermatitis acneiform
21%
Urinary tract infection
21%
Hypokalaemia
18%
Weight decreased
18%
Alopecia
18%
Dizziness
15%
Dehydration
15%
Anaemia
15%
Constipation
15%
Headache
15%
Epistaxis
12%
Pyrexia
12%
Oedema peripheral
12%
Pain
12%
Paronychia
12%
Blood creatinine increased
12%
Aspartate aminotransferase increased
12%
Musculoskeletal pain
12%
Arthralgia
12%
Anxiety
12%
Cough
12%
Dyspnoea
12%
Oropharyngeal pain
9%
Conjunctivitis
9%
Blood alkaline phosphatase increased
9%
Blood potassium decreased
9%
Alanine aminotransferase increased
9%
Hypomagnesaemia
9%
Dysgeusia
9%
Burning sensation
9%
Agitation
9%
Pleural effusion
9%
Rash maculo-papular
9%
Pruritus
6%
Pericardial effusion
6%
Rhinorrhoea
6%
Eye discharge
6%
Hypertension
6%
Thrombocytopenia
6%
Dry eye
6%
Dry mouth
6%
Abdominal distension
6%
Cheilitis
6%
Chills
6%
Fungal infection
6%
Vulvovaginal mycotic infection
6%
Blood uric acid increased
6%
Hyponatraemia
6%
Muscular weakness
6%
Myalgia
6%
Somnolence
6%
Urinary incontinence
6%
Vulvovaginal discomfort
6%
Palmar-plantar erythrodysaesthesia syndrome
6%
Erythema
6%
Pruritus generalised
6%
Rash macular
6%
Skin lesion
6%
Abdominal pain upper
6%
Asthenia
6%
Cellulitis
6%
Dysuria
3%
Eye irritation
3%
Ocular hyperaemia
3%
Sinusitis
3%
Tinea pedis
3%
Hiccups
3%
Nasal dryness
3%
Dysphonia
3%
Sinus congestion
3%
Ophthalmic herpes zoster
3%
Upper respiratory tract infection
3%
Cataract
3%
Blood urea increased
3%
Oral pain
3%
Platelet count decreased
3%
Skin irritation
3%
Dermatitis bullous
3%
Rash generalised
3%
Acute respiratory failure
3%
Vitreous floaters
3%
Oral discomfort
3%
Gastritis
3%
Gingival pain
3%
Glossodynia
3%
Candida infection
3%
Skin candida
3%
Neuropathy peripheral
3%
Lymphopenia
3%
Oral candidiasis
3%
Ear pain
3%
Hypothyroidism
3%
Soft tissue infection
3%
Eye swelling
3%
Flatulence
3%
Gastrooesophageal reflux disease
3%
Proctalgia
3%
Dysphagia
3%
Cardio-respiratory arrest
3%
Lip oedema
3%
Mouth ulceration
3%
Influenza like illness
3%
Oedema
3%
Gait disturbance
3%
Multiple organ dysfunction syndrome
3%
Herpes zoster
3%
Rash pustular
3%
Pneumonia
3%
Femur fracture
3%
Haemorrhage intracranial
3%
Spinal cord compression
3%
Syncope
3%
Respiratory failure
3%
Fall
3%
Nail injury
3%
Procedural pain
3%
Scapula fracture
3%
Blood magnesium decreased
3%
Lymphocyte count decreased
3%
White blood cell count increased
3%
Neutrophil count increased
3%
Blood bilirubin increased
3%
Blood calcium decreased
3%
Glomerular filtration rate decreased
3%
Glomerular filtration rate increased
3%
Haematocrit decreased
3%
Haemoglobin decreased
3%
Liver function test abnormal
3%
Neutrophil count decreased
3%
Hypophosphataemia
3%
Hypercalcaemia
3%
Acidosis
3%
Hyperphosphataemia
3%
Balance disorder
3%
Depression
3%
Insomnia
3%
Delirium
3%
Irritability
3%
Breast pain
3%
Vulvovaginal inflammation
3%
Perineal pain
3%
Vulvovaginal burning sensation
3%
Nasal congestion
3%
Paranasal sinus discomfort
3%
Pleuritic pain
3%
Respiratory tract congestion
3%
Throat irritation
3%
Rash erythematous
3%
Skin disorder
3%
Urticaria
3%
Skin lesion excision
3%
Hypotension
3%
Lymphoedema
3%
Angular cheilitis
3%
Cystitis
3%
Ear infection
3%
Localised infection
3%
Back pain
3%
Musculoskeletal chest pain
3%
Bone pain
3%
Musculoskeletal stiffness
3%
Pain in extremity
3%
Breast cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Poziotinib 24 mg
Cohort 2: Poziotinib 16 mg

PINNACLE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Poziotinib 8 mgExperimental Treatment1 Intervention
Participants will receive poziotinib 8 mg, orally, BID, in 21 day cycles or until disease progression, death, intolerable adverse events (AEs), initiation of non-protocol anti-cancer treatment, or other protocol-specified reasons for participant withdrawal from the study.
Group II: Docetaxel 75 mg/m^2Active Control1 Intervention
Participants will receive docetaxel 75 mg/m^2, intravenously (IV) on Day 1 of each 21-day treatment cycle or until disease progression, death, intolerable AEs, initiation of non-protocol anti-cancer treatment, or other protocol-specified reasons for participant withdrawal from the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Poziotinib
2016
Completed Phase 2
~340

Find a Location

Who is running the clinical trial?

Spectrum Pharmaceuticals, IncLead Sponsor
82 Previous Clinical Trials
7,898 Total Patients Enrolled
~168 spots leftby Dec 2027
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