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Small Molecule 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 from first dose of capmatinib to last dose, up to 2.4 years

Awards & highlights

Study Summary

This trial is testing a combination of two drugs, capmatinib and spartalizumab, versus capmatinib and placebo as a potential treatment for NSCLC. The trial is double-blind and placebo-controlled, meaning that neither the patients nor the researchers will know who is receiving the active treatment and who is receiving the placebo. The trial is also randomized, meaning that patients will be assigned to the treatment groups by chance. This is a phase II trial, which means that the researchers are primarily interested in whether the treatment is effective and safe, rather than whether it is better than the current standard of care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of capmatinib to last dose, up to 2.4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of capmatinib to last dose, up to 2.4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of capmatinib to last dose, up to 2.4 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

Randomized Part: Progression-Free Survival (PFS) by BIRC as Per RECIST 1.1

Run-in Part: Overall Response Rate (ORR) by Investigator Assessment as Per RECIST 1.1

Secondary outcome measures

Randomized Part: Area Under the Concentration-time Curve From Time Zero to the End of a Dosing Interval (AUCtau) of Capmatinib and Spartalizumab

Randomized Part: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Capmatinib and Spartalizumab

Randomized Part: Change From Baseline in EORTC QLQ-C30

+29 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

Lung abscess

Intestinal obstruction

Breast pain

Herpes zoster

Hepatotoxicity

Hyperkalaemia

Face oedema

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

3Treatment groups

Experimental Treatment

Group I: Run-in partExperimental Treatment2 Interventions

capmatinib in combination with spartalizumab

Group II: Randomized part - Arm 2 placeboExperimental Treatment2 Interventions

capmatinib in combination with placebo

Group III: Randomized part - Arm 1 spartalizumabExperimental Treatment2 Interventions

capmatinib in combination with spartalizumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capmatinib

2021

Completed Phase 3

~570

Spartalizumab

2020

Completed Phase 2

~280

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

4,197,712 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 other examples of Capmatinib being used in medical research?

"Currently, there are 40 ongoing clinical trials evaluating the efficacy of Capmatinib. 4 of those trials are Phase 3 studies. New york, New York hosts many of the Capmatinib studies, but there are a total of 806 sites running clinical trials for this medication."

Answered by AI

Are there any slots still available for this research project?

"This particular trial is not seeking new candidates at the moment. However, it is worth noting that there are other active trials (1386 studies recruiting patients with carcinoma, non-small-cell lung and 40 trials for Capmatinib) that might be of interest."

Answered by AI

Are there any short-term risks associated with taking Capmatinib?

"Capmatinib's safety is based off of Phase 2 trial data, meaning that while there is some evidence that it is safe, there is no guarantee of its effectiveness."

Answered by AI

Have researchers done anything like this before?

"Capmatinib has a long history of clinical research, with the first trial being sponsored by Novartis Pharmaceuticals back in 2011. Just 185 people were involved in the initial study. Now, 40 different trials are ongoing in 192 cities and 41 countries."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations

2020. "Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04323436.