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Tyrosine Kinase Inhibitor

EGF816 for Non-Small Cell Lung Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
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 cycle (c) 1 day (d) 1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hours (hrs) post-dose), c1d15 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose) (for phase i part only) and c2d1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose).
Awards & highlights

Study Summary

This trial is a Phase I/II study, which means it is testing a new drug to see if it is safe and effective. The first part (Phase I) is a dose-escalation phase, which is designed to find the maximum tolerated dose (MTD) or recommended Phase II dose (RP2D) of the drug. The second part (Phase II) is an expansion phase, which is designed to estimate the antitumor activity of the drug.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle (c) 1 day (d) 1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hours (hrs) post-dose), c1d15 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose) (for phase i part only) and c2d1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose).
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle (c) 1 day (d) 1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hours (hrs) post-dose), c1d15 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose) (for phase i part only) and c2d1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Dose Limiting Toxicities (DLTs) (Phase I Part)
Overall Response Rate (ORR) by Blinded Independent Review Committee (BIRC) (Phase II Part)
Secondary outcome measures
Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part)
Change From Baseline in H-score for Immunohistochemistry (IHC) Biomarkers From Tumor Tissue Samples (Phase I Part)
Disease Control Rate (DCR) by BIRC (Phase II Part)
+12 more

Side effects data

From 2023 Phase 1 & 2 trial • 225 Patients • NCT02108964
44%
Diarrhoea
38%
Rash maculo-papular
34%
Pruritus
29%
Stomatitis
26%
Cough
26%
Fatigue
22%
Dry skin
22%
Decreased appetite
20%
Nausea
15%
Vomiting
15%
Constipation
15%
Back pain
14%
Anaemia
14%
Headache
14%
Dyspnoea
13%
Pyrexia
13%
Paronychia
13%
Dermatitis acneiform
13%
Upper respiratory tract infection
11%
Muscle spasms
11%
Oedema peripheral
11%
Dizziness
10%
Rash
8%
Nasopharyngitis
8%
Insomnia
8%
Urticaria
8%
Pneumonia
8%
Arthralgia
8%
Musculoskeletal chest pain
8%
Rhinorrhoea
7%
Alanine aminotransferase increased
7%
Aspartate aminotransferase increased
7%
Blood creatinine increased
7%
Pain in extremity
7%
Myalgia
7%
Hypertension
7%
Rash macular
6%
Dyspepsia
6%
Abdominal pain
6%
Haemoptysis
6%
Non-cardiac chest pain
6%
Urinary tract infection
5%
Epistaxis
5%
Dysgeusia
5%
Abdominal pain upper
4%
Neutropenia
4%
Influenza like illness
4%
Dry eye
4%
Abdominal distension
4%
Dry mouth
4%
Gastrooesophageal reflux disease
4%
Asthenia
4%
Conjunctivitis
4%
Herpes zoster
4%
Pharyngitis
4%
Blood creatine phosphokinase increased
4%
Weight decreased
4%
Hyperkalaemia
4%
Muscular weakness
4%
Neck pain
4%
Oropharyngeal pain
4%
Rash papular
4%
Vision blurred
4%
Chills
4%
Platelet count decreased
4%
Hypokalaemia
4%
Alopecia
4%
Dyspnoea exertional
3%
Thrombocytopenia
3%
Procedural pain
3%
Gamma-glutamyltransferase increased
3%
Hyperuricaemia
3%
Flank pain
3%
Productive cough
3%
Pleural effusion
3%
Eczema
3%
Skin fissures
3%
Hypomagnesaemia
2%
Haemorrhoids
2%
Aphthous ulcer
2%
Chest discomfort
2%
Hepatitis B reactivation
2%
Sepsis
2%
Confusional state
2%
Flatulence
2%
Gastritis
2%
Blood alkaline phosphatase increased
2%
Blood bilirubin increased
2%
Hepatic function abnormal
2%
Respiratory tract infection
2%
Neuropathy peripheral
2%
Electrocardiogram QT prolonged
2%
Neutrophil count decreased
2%
Hyponatraemia
2%
Hypophosphataemia
2%
Dehydration
2%
Hyperglycaemia
2%
Hypocalcaemia
2%
Cancer pain
2%
Rash erythematous
2%
Depression
2%
Pollakiuria
2%
Paraesthesia
2%
Dysuria
2%
Anxiety
2%
Nasal congestion
2%
Urinary incontinence
2%
Nasal dryness
2%
Acne
2%
Rhinitis allergic
2%
Hypoaesthesia
2%
Viral upper respiratory tract infection
2%
Skin exfoliation
2%
Hypoalbuminaemia
2%
Xerosis
2%
Haematoma
1%
Pulmonary haemorrhage
1%
Atrial fibrillation
1%
Pneumonia aspiration
1%
Pneumothorax
1%
Subdural haematoma
1%
Seizure
1%
Gastrointestinal haemorrhage
1%
Femur fracture
1%
Odynophagia
1%
Enterocolitis
1%
Peripheral swelling
1%
Lung infection
1%
Acute kidney injury
1%
Rash pustular
1%
Pneumonitis
1%
Eosinophilia
1%
Angina pectoris
1%
Conjunctivitis viral
1%
Bronchitis
1%
Oral candidiasis
1%
Onychomycosis
1%
Lower respiratory tract infection
1%
Folliculitis
1%
Rhinitis
1%
Tonsillitis
1%
Contusion
1%
Ligament sprain
1%
Cognitive disorder
1%
Ataxia
1%
Bone pain
1%
Aphasia
1%
Hyperaesthesia
1%
Amnesia
1%
Memory impairment
1%
Urinary retention
1%
Hiccups
1%
Pelvic pain
1%
Pharyngeal inflammation
1%
Laryngeal inflammation
1%
Decubitus ulcer
1%
Nail ridging
1%
Skin discolouration
1%
Hyperhidrosis
1%
Eczema asteatotic
1%
Pericardial effusion
1%
Meningitis
1%
Pneumonia bacterial
1%
Sinus tachycardia
1%
Ocular hyperaemia
1%
Cheilitis
1%
Oral pain
1%
Skin infection
1%
Amylase increased
1%
Dysphonia
1%
Swelling face
1%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Subjects
EGF816 100 mg (Phase I Part)
EGF816 350 mg (Phase I Part)
EGF816 150 mg (Phase I Part)
EGF816 225 mg (Phase I Part)
EGF816 200 mg (Phase I Part)
EGF816 300 mg (Phase I Part)
EGF816 75 mg (Phase I Part)
EGF816 150 mg (Phase II Part)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase II partExperimental Treatment1 Intervention
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations will be administered with EGF816 at RP2D during Phase II part of the study.
Group II: Phase I partExperimental Treatment1 Intervention
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations will be administered escalated doses of EGF816 orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study. The starting dose for the Phase I part first cohort of patients will be 75 mg once per day capsule.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EGF816
2014
Completed Phase 2
~530

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,125 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any additional investigations into EGF816?

"At the present, there are zero Phase 3 trials in progress for EGF816 and 6 active studies. Surprisingly, researchers have chosen to conduct clinical tests at 55 distinct locations across the globe including Madrid and Alberta."

Answered by AI

Are any enrollees still being accepted for this research project?

"Clinicaltrials.gov attests that this clinical trial, posted June 6th 2014 and last updated October 21st 2022, is not actively searching for candidates at present. However, there are 1,370 other trials with open recruitment across the globe."

Answered by AI

To what extent is the research sample population participating in this experiment?

"While this trial is no longer searching for participants, according to clinicaltrials.gov, it was first posted on June 6th 2014 and last updated October 21st 2022. There are currently 1,364 trials looking for individuals with carcinoma non-small-cell lung cancer and six studies actively recruiting patientsfor EGF816 treatment."

Answered by AI

What are the foremost aims of this experiment?

"The 28-day clinical trial seeks to assess the Overall Response Rate (ORR) as judged by a Blinded Independent Review Committee (BIRC). Supplementary objectives include determining the Duration of Response (DOR), Observed Maximum Plasma Concentration (Cmax) and Time to Maximum Plasma Concentration (Tmax) for EGF816 and its metabolite LMI258."

Answered by AI

Is this experiment a pioneering effort in its field?

"At present, there are 6 ongoing clinical trials for EGF816 in 18 cities and 13 nations. The initial trial was conducted by Novartis Pharmaceuticals back in 2014 with 225 participants over two stages of drug approval. Since then, one more has been administered."

Answered by AI
Recent research and studies
The Lancet Respiratory MedicineJournal
Safety and Efficacy of Nazartinib (EGF816) in Adults with Egfr-mutant Non-small-cell Lung Carcinoma: A Multicentre, Open-label, Phase 1 Study
Tan, Daniel S-W, Natasha B Leighl, Gregory J Riely, James C-H Yang, Lecia V Sequist, Juergen Wolf, Takashi Seto, et al.. 2020. “Safety and Efficacy of Nazartinib (EGF816) in Adults with Egfr-mutant Non-small-cell Lung Carcinoma: A Multicentre, Open-label, Phase 1 Study”. The Lancet Respiratory Medicine. Elsevier BV. doi:10.1016/s2213-2600(19)30267-x.
European Journal of CancerJournal
Nazartinib for Treatment-naive Egfr-mutant Non−small Cell Lung Cancer: Results of a Phase 2, Single-arm, Open-label Study
Tan, Daniel S.W., Sang-We Kim, Santiago Ponce Aix, Lecia V. Sequist, Egbert F. Smit, James C.H. Yang, Toyoaki Hida, et al.. 2022. “Nazartinib for Treatment-naive Egfr-mutant Non−small Cell Lung Cancer: Results of a Phase 2, Single-arm, Open-label Study”. European Journal of Cancer. Elsevier BV. doi:10.1016/j.ejca.2022.05.023.
European Journal of CancerJournal
Nazartinib for Treatment-naive Egfr-mutant Non−small Cell Lung Cancer: Results of a Phase 2, Single-arm, Open-label Study
Tan, Daniel S.W., Sang-We Kim, Santiago Ponce Aix, Lecia V. Sequist, Egbert F. Smit, James C.H. Yang, Toyoaki Hida, et al.. 2022. “Nazartinib for Treatment-naive Egfr-mutant Non−small Cell Lung Cancer: Results of a Phase 2, Single-arm, Open-label Study”. European Journal of Cancer. Elsevier BV. doi:10.1016/j.ejca.2022.05.023.
clinicaltrials.govStudy
A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies
2014. "A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02108964.
~21 spots leftby Apr 2025
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