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Tyrosine Kinase Inhibitor

EGF816 + Targeted Agents for Non-Small Cell Lung Cancer

Phase 1
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
Patients must have histologically or cytologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) EGFR mutant (ex19del, L858R) NSCLC.
Patients must have a site of disease amenable to biopsy and be willing to undergo new tumor biopsy during therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8-12 weeks until study ends, approximately 4 years
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of adding different drugs to EGF816 in order to treat advanced EGFR-mutant NSCLC.

Who is the study for?
This trial is for adults with advanced EGFR-mutant NSCLC who haven't had treatment yet or have specific mutations after initial therapy. They must have a tumor that can be biopsied and agree to the procedure. Excluded are those in other drug studies, with unstable brain tumors, lung conditions like pneumonitis, HIV, recent certain therapies, uncontrolled heart disease, or another cancer history.Check my eligibility
What is being tested?
The study tests how safe and effective EGF816 is when combined with INC280, trametinib, ribociclib, gefitinib, or LXH254 in patients with advanced EGFR-mutant NSCLC. It aims to find out if adding these targeted agents improves outcomes for these patients.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as skin rash or liver inflammation; gastrointestinal issues like nausea; potential increase in blood pressure; fatigue; and risks associated with biopsies such as pain or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung cancer is advanced or has spread, and tests show it has specific EGFR mutations.
Select...
I am willing to have a biopsy of my cancer.
Select...
I have a specific lung cancer mutation and haven't received treatment yet.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8-12 weeks until study ends, approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8-12 weeks until study ends, approximately 4 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
Number of patients with adverse events and serious adverse events
ORR2
Secondary outcome measures
DCR
DOR
ORR
+2 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

10Treatment groups
Experimental Treatment
Group I: Arm GExperimental Treatment2 Interventions
EGF816 + INC280 in expansion phase (patients with known resistance mechanism)
Group II: Arm FExperimental Treatment2 Interventions
EGF816 + gefitinib in expansion phase
Group III: Arm EExperimental Treatment2 Interventions
EGF816 + LXH254 in expansion phase (patients with known resistance mechanism)
Group IV: Arm DExperimental Treatment2 Interventions
EGF816 + LXH254 in expansion phase (patients with no known resistance mechanism)
Group V: Arm CExperimental Treatment2 Interventions
EGF816 + ribociclib in expansion phase
Group VI: Arm BExperimental Treatment2 Interventions
EGF816 + trametinib in expansion phase
Group VII: Arm AExperimental Treatment2 Interventions
EGF816 + INC280 in expansion phase (patients with no known resistance mechanism)
Group VIII: Arm 3Experimental Treatment2 Interventions
EGF816 + LXH254 in escalation phase
Group IX: Arm 2Experimental Treatment2 Interventions
EGF816 + ribociclib in escalation phase
Group X: Arm 1Experimental Treatment2 Interventions
EGF816+ trametinib in escalation phase
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EGF816
2014
Completed Phase 2
~530
trametinib
2012
Completed Phase 2
~200
ribociclib
2016
Completed Phase 3
~560
INC280
2014
Completed Phase 2
~1020
gefitinib
2003
Completed Phase 3
~2750

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,248 Total Patients Enrolled

Media Library

EGF816 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03333343 — Phase 1
Non-Small Cell Lung Cancer Clinical Trial 2023: EGF816 Highlights & Side Effects. Trial Name: NCT03333343 — Phase 1
EGF816 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03333343 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Arm C, Arm G, Arm 3, Arm A, Arm 1, Arm 2, Arm B, Arm F, Arm D, Arm E

Frequently Asked Questions

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

In what contexts are doctors likely to issue EGF816 as a remedy?

"EGF816 is the prevailing therapy for unresectable melanoma and has applications in malignant neoplasms, postmenopause scenarios, and treatment naive cases."

Answered by AI

How many participants are being recruited to this research project?

"Unfortunately, this trial is no longer enlisting patients. It was first published on January 29th 2018 and the last edit was made June 28th 2022. If you are seeking other medical trials that may be suitable for your needs, there are 1362 currently recruiting participants with Carcinoma Non-Small cell lung cancer and 170 active investigations exploring EGF816 treatments."

Answered by AI

What other experiments involving EGF816 have been conducted to date?

"Presently, 170 trials are underway that investigate EGF816, with 25 of them being Phase 3. Most clinical trials for this particular treatment occur in Portland, Oregon; however, 7927 medical centres globally have studies pertaining to it."

Answered by AI

To what degree is EGF816 safe for human consumption?

"Our team at Power scored EGF816 with a 1 on the safety scale as this is an early-stage investigation, indicating limited data that can verify its efficacy and precautionary measures."

Answered by AI

Are there still enrollees being sought for this research project?

"As per the clinicaltrials.gov entry, this medical trial is not accepting new patients at present. It was first posted on January 29th 2018 and last updated on June 28th 2022; however, 1532 additional trials are actively searching for participants as we speak."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC
2018. "Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03333343.
~9 spots leftby Dec 2024
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