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Kinase Inhibitor

Capmatinib for Non-Small Cell Lung Cancer

Phase 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 up to 2.1 years

Awards & highlights

Study Summary

This trial is testing whether adding the drug capmatinib to the drug pembrolizumab improves treatment of patients with a certain type of lung cancer.

Eligible Conditions

Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2.1 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2.1 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.1 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) by Investigator Assessment as Per RECIST 1.1

Secondary outcome measures

Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Capmatinib

Disease Control Rate (DCR) by Investigator Assessment as Per RECIST 1.1

Duration of Response (DOR) by Investigator Assessment as Per RECIST 1.1

+8 more

Side effects data

From 2023 Phase 2 trial • 373 Patients • NCT02414139

49%

Oedema peripheral

46%

Nausea

32%

Vomiting

26%

Diarrhoea

23%

Constipation

23%

Blood creatinine increased

22%

Decreased appetite

19%

Alanine aminotransferase increased

16%

Dyspnoea

16%

Fatigue

16%

Aspartate aminotransferase increased

13%

Hypoalbuminaemia

13%

Amylase increased

13%

Gamma-glutamyltransferase increased

13%

Hypophosphataemia

13%

Cough

13%

Dry skin

12%

Non-cardiac chest pain

12%

Back pain

12%

Pyrexia

12%

Blood alkaline phosphatase increased

10%

Nasopharyngitis

10%

Pneumonia

10%

Weight decreased

10%

Weight increased

10%

Pruritus

10%

Insomnia

Headache

Pleural effusion

Asthenia

Arthralgia

Pain in extremity

Anaemia

Lipase increased

Hypokalaemia

Dizziness

Pain

Hypotension

Abdominal pain upper

Dyspepsia

Muscle spasms

Myalgia

Dysphonia

Hypertension

Gastrooesophageal reflux disease

Respiratory failure

General physical health deterioration

Cellulitis

Blood albumin decreased

Blood bilirubin increased

Platelet count decreased

C-reactive protein increased

Neutrophil count decreased

Musculoskeletal pain

Dysgeusia

Pneumonitis

Haemoptysis

Productive cough

Rash

Seizure

Neutropenia

Musculoskeletal chest pain

Cardiac failure

Dysphagia

Hyponatraemia

Vertigo

Hypoacusis

Atrial fibrillation

Abdominal pain

Malaise

White blood cell count decreased

Hypomagnesaemia

Somnolence

Confusional state

Rash maculo-papular

Pneumothorax

Intestinal obstruction

Breast pain

Herpes zoster

Hepatotoxicity

Hyperkalaemia

Face oedema

Lung abscess

Dermatitis acneiform

Duodenitis

Oesophageal stenosis

Pancreatitis acute

Generalised oedema

Vascular device occlusion

Hepatitis

Influenza

Medical device site infection

Respiratory tract infection

Pneumonia bacterial

Femur fracture

Tumour pain

Bone pain

Muscular weakness

Cerebral ischaemia

Hemiparesis

Aphasia

Cerebral mass effect

Epilepsy

Acute kidney injury

Renal failure

Jugular vein thrombosis

Abdominal discomfort

Superior vena cava syndrome

Embolism

Leukopenia

Hyperthyroidism

Tinnitus

Palpitations

Thrombocytopenia

Oedema

Stomatitis

Chest discomfort

Peripheral swelling

Bronchitis

Fall

Spinal compression fracture

Hypercalcaemia

Hypocalcaemia

Sleep disorder

Dysuria

Paraesthesia

Depression

Hypoaesthesia

Neuropathy peripheral

Oropharyngeal pain

Pulmonary embolism

Rhinorrhoea

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1a: On-treatment

Cohort 1b: On-treatment

Cohort 6.2 (Expansion of Cohort 4): Post-treatment Efficacy/Survival Follow-up Period

All Patients: Post-treatment Efficacy/Survival Follow-up

Cohort 2: On-treatment

Cohort 5a: Post-treatment Efficacy/Survival Follow-up Period

Cohort 4 + Cohort 6.2: On-treatment

Cohort 3: On-treatment

Cohort 4: On-treatment

Cohort 6.1 (Expansion of Cohort 1a): On-treatment

Cohort 3: Post-treatment Efficacy/Survival Follow-up Period

Cohort 5b: Post-treatment Efficacy/Survival Follow-up Period

Cohort 7 (Expansion of Cohort 5b): Post-treatment Efficacy/Survival Follow-up Period

Cohort 5b: On-treatment

Cohort 5b + Cohort 7: On-treatment

All Patients: On-treatment

Cohort 5a: On-treatment

Cohort 6.1 (Expansion of Cohort 1a): Post-treatment Efficacy/Survival Follow-up Period

Cohort 1b: Post-treatment Efficacy/Survival Follow-up Period

Cohort 5b + Cohort 7: Post-treatment Efficacy/Survival Follow-up Period

Cohort 6.2 (Expansion of Cohort 4): On-treatment

Cohort 7 (Expansion of Cohort 5b): On-treatment

Cohort 1a: Post-treatment Efficacy/Survival Follow-up

Cohort 4: Post-treatment Efficacy/Survival Follow-up Period

Cohort 2: Post-treatment Efficacy/Survival Follow-up Period

Cohort 4 + Cohort 6.2: Post-treatment Efficacy/Survival Follow-up Period

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Capmatinib 400mg BID + pembrolizumab 200mg Q3WExperimental Treatment2 Interventions

Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W)

Group II: Pembrolizumab 200mg Q3WActive Control1 Intervention

Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capmatinib

2021

Completed Phase 3

~570

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,667 Total Patients Enrolled

Frequently Asked Questions

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

Has Capmatinib previously been tested during a scientific research study?

"Currently, there are 975 active studies investigating Capmatinib with 125 trials at Phase 3. Although Houston, Texas is particularly invested in this research with numerous clinical trials, there are 36052 sites across the world conducting these investigations."

Answered by AI

What malady is Capmatinib usually prescribed to alleviate?

"Capmatinib has been proven to be an effective treatment for malignant neoplasms, unresectable melanoma and certain cases of microsatellite instability high."

Answered by AI

Are there open slots available for participants in this clinical experiment?

"The information found on clinicaltrials.gov reveals that this research trial is no longer actively seeking participants; the study was initially posted on January 22nd 2020 and it's most recent edit was made November 23rd 2022. Despite not being able to join this particular investigation, there are a plethora of other studies looking for volunteers at present time with 2883 opportunities available."

Answered by AI

How many participants are receiving treatment in this clinical investigation?

"Currently, this trial is no longer recruiting participants. The listing was initially posted on January 22nd 2020 and the last edit occurred November 23rd 2022. For those seeking alternative studies there are 1908 active trials for non-small cell lung carcinoma and 975 open studies involving Capmatinib that still require volunteers."

Answered by AI

What risks does Capmatinib pose to patients?

"Due to the lack of evidence in regards to efficacy, capmatinib is estimated as a 2 on our safety scale. This rating indicates that there exists some data backing its safety but none for effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of Capmatinib (INC280) Plus Pembrolizumab vs Pembrolizumab Alone in NSCLC With PD-L1≥ 50%

2020. "Safety and Efficacy of Capmatinib (INC280) Plus Pembrolizumab vs Pembrolizumab Alone in NSCLC With PD-L1≥ 50%". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04139317.