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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study day 42 (6 weeks)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study day 42 (6 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study day 42 (6 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and study day 42 (6 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion

Overall response rate (ORR)

Secondary outcome measures

Disease Control Rate (DCR)

Duration of Response (DOR)

Overall survival (OS)

+2 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533

57%

Nausea

54%

Anaemia

51%

Fatigue

39%

Decreased appetite

36%

Malignant neoplasm progression

32%

Constipation

31%

Diarrhoea

30%

Cough

29%

Vomiting

29%

Dyspnoea

25%

Oedema peripheral

24%

Back pain

21%

Pyrexia

21%

Neutropenia

19%

Headache

19%

Hypomagnesaemia

18%

Arthralgia

16%

Asthenia

16%

Dizziness

16%

Neutrophil count decreased

15%

Thrombocytopenia

15%

Insomnia

14%

Hyponatraemia

14%

Rash

14%

Weight decreased

14%

Platelet count decreased

13%

Blood creatinine increased

13%

White blood cell count decreased

12%

Hypokalaemia

12%

Pruritus

12%

Abdominal pain

12%

Pain in extremity

11%

Myalgia

11%

Alanine aminotransferase increased

11%

Aspartate aminotransferase increased

10%

Alopecia

10%

Dry skin

10%

Hypoalbuminaemia

10%

Muscular weakness

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Bronchitis

Blood alkaline phosphatase increased

Chills

Hypertension

Dehydration

Hyperkalaemia

Hyperglycaemia

Lymphocyte count decreased

Anxiety

Leukopenia

Hypophosphataemia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Rash maculo-papular

Hypotension

Musculoskeletal chest pain

Malaise

Pain

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Sepsis

Malignant pleural effusion

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Hypercalcaemia

Neoplasm progression

Small intestinal haemorrhage

Femur fracture

Pericardial effusion malignant

Cancer pain

Confusional state

Pneumothorax

Circulatory collapse

Bone pain

Atrial flutter

Bronchial obstruction

Superior vena cava syndrome

Syncope

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

Study treatment Arm

Investigator Choice of Chemotherapy

Post Chemotherapy Optional Nivolumab

Nivolumab

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

~4750

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,293 Total Patients Enrolled

Media Library

Ceritinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02393625 — Phase 1

Non-Small Cell Lung Cancer Research Study Groups: Dose Expansion, Dose Escalation

Non-Small Cell 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

Frequently Asked Questions

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

How many volunteers are engaging in this clinical trial?

"This clinical trial is not currently recruiting members. The post was first uploaded on May 27th 2015 and most recently modified on June 30th 2022. If you are searching for other studies, there are 1363 trials that accept participants with carcinoma non-small-cell lung cancer and 728 Nivolumab related experiments in need of volunteers."

Answered by AI

Is Nivolumab a risk-free treatment solution for patients?

"Due to the limited data available from Phase 1 trials, Nivolumab's safety was assessed as a score of 1."

Answered by AI

Does this research require additional participants?

"Unfortunately, according to the clinicaltrials.gov website this experiment is no longer recruiting participants as it was last updated on June 30th 2022. Despite this trial's closure there are still 2091 other studies actively enrolling patients at present."

Answered by AI

Is this research endeavor an unprecedented exploration?

"Currently, 728 ongoing clinical studies involving Nivolumab are being conducted across 2418 cities and 51 countries. This drug was first tested in 2012 by Ono Pharmaceutical Co. Ltd with a Phase 1 & 2 study of 659 patients; since then, 269 additional trials have been completed."

Answered by AI

What preceding studies have utilized Nivolumab to analyze its potential therapeutic effects?

"Presently, there are 728 active clinical trials examining the effects of Nivolumab with 85 in Phase 3. Basel BE is one of 41102 locations that have undertaken research into this drug's efficacy."

Answered by AI

What ailments does Nivolumab typically target?

"Nivolumab is often used to address anti-angiogenic therapy and can also be utilized for treating malignant neoplasms, inoperable melanoma, and squamous cell carcinoma."

Answered by AI

Are there many locations administering this clinical research in the state?

"The trial is currently enrolling patients at Massachusetts General Hospital Thoracic Oncology in Boston, Fox Chase Cancer Center Study Coordinator in Philadelphia, and Novartis Investigative Site in Toronto. Additionally, there are 4 other sites allowing participation."

Answered by AI

Recent research and studies

Journal of Thoracic OncologyJournal

Phase 1/2 Study of the Safety and Tolerability of Nivolumab Plus Crizotinib for the First-line Treatment of Anaplastic Lymphoma Kinase Translocation — Positive Advanced Non–small Cell Lung Cancer (checkmate 370)

Spigel, David R., Craig Reynolds, David Waterhouse, Edward B. Garon, Jason Chandler, Sunil Babu, Paul Thurmes, et al.. 2018. “Phase 1/2 Study of the Safety and Tolerability of Nivolumab Plus Crizotinib for the First-line Treatment of Anaplastic Lymphoma Kinase Translocation — Positive Advanced Non–small Cell Lung Cancer (checkmate 370)”. Journal of Thoracic Oncology. Elsevier BV. doi:10.1016/j.jtho.2018.02.022.

clinicaltrials.govStudy

Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer

2015. "Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02393625.

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