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Tyrosine Kinase Inhibitor

Ceritinib + Nivolumab 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
Histologically or cytologically confirmed diagnosis of NSCLC that carries an ALK rearrangement
Stage IIIB or IV NSCLC or relapsed locally advanced or metastatic NSCLC
Must not have
Unable or unwilling to swallow tablets or capsules
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat lung cancer in people who have a specific gene mutation. The goal is to see if it is safe and effective.

Who is the study for?
This trial is for adults with ALK-positive Non-Small Cell Lung Cancer (NSCLC) who may have had previous cancer treatments but recovered from most side effects. They should have at least one measurable tumor and be in good physical condition (WHO performance status 0-1). People with other recent cancers, autoimmune diseases, difficulty swallowing pills, or severe medical conditions can't participate.
What is being tested?
The study is testing the combination of two drugs: Ceritinib and Nivolumab, to see how safe and effective they are together for treating NSCLC patients with an ALK rearrangement. It's an open-label trial which means everyone knows what treatment they're getting.
What are the potential side effects?
Possible side effects include diarrhea, nausea, liver enzyme elevation from Ceritinib; while Nivolumab might cause immune-related issues like inflammation in organs or skin problems. Side effects vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung cancer is ALK-positive.
Select...
My lung cancer is at an advanced stage or has spread.
Select...
I can carry out all my daily activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot or do not want to swallow pills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall response rate (ORR)

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%
Tinnitus
10%
Cushingoid
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment2 Interventions
Group II: Dose EscalationExperimental Treatment2 Interventions
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?

Novartis PharmaceuticalsLead Sponsor
2,905 Previous Clinical Trials
4,208,058 Total Patients Enrolled

Media Library

Ceritinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02393625 — Phase 1
Lung Cancer Research Study Groups: Dose Expansion, Dose Escalation
Lung Cancer Clinical Trial 2023: Ceritinib Highlights & Side Effects. Trial Name: NCT02393625 — Phase 1
Ceritinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02393625 — Phase 1
~2 spots leftby Apr 2025
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