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cMET Inhibitor
Cohort 5a: Treatment-naïve patients with MET GCN ≥10 (1L) 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 approximately 6 years
Awards & highlights
Study Summary
This trial will evaluate a new drug to treat advanced lung cancer in patients who have a specific gene mutation. The trial will also look at the safety and how the body processes the drug.
Eligible Conditions
- Non-Small Cell Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR) by Blinded Independent Review Committee (BIRC) Assessment
Secondary outcome measures
Area Under the Plasma Concentration-time Curve From Zero to Time Infinity (AUCinf) of CMN288
Area Under the Plasma Concentration-time Curve From Zero to Time Infinity (AUCinf) of Capmatinib
DOR by Investigator Assessment
+14 moreSide effects data
From 2023 Phase 2 trial • 373 Patients • NCT0241413949%
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%
Gamma-glutamyltransferase increased
13%
Hypoalbuminaemia
13%
Hypophosphataemia
13%
Dry skin
13%
Amylase increased
13%
Cough
12%
Non-cardiac chest pain
12%
Pyrexia
12%
Back pain
12%
Blood alkaline phosphatase increased
10%
Pruritus
10%
Nasopharyngitis
10%
Pneumonia
10%
Weight decreased
10%
Weight increased
10%
Insomnia
9%
Headache
9%
Pain in extremity
9%
Pleural effusion
9%
Asthenia
9%
Arthralgia
7%
Anaemia
7%
Lipase increased
7%
Hypokalaemia
6%
Muscle spasms
6%
Dysphonia
6%
Pain
6%
Dizziness
6%
Hypertension
6%
Hypotension
6%
Abdominal pain upper
6%
Dyspepsia
6%
Myalgia
4%
Rash
4%
Dysgeusia
4%
General physical health deterioration
4%
Respiratory failure
4%
Gastrooesophageal reflux disease
4%
Cellulitis
4%
Musculoskeletal pain
4%
Pneumonitis
4%
Productive cough
4%
Blood albumin decreased
4%
Blood bilirubin increased
4%
Platelet count decreased
4%
C-reactive protein increased
4%
Neutrophil count decreased
4%
Haemoptysis
3%
Musculoskeletal chest pain
3%
Rash maculo-papular
3%
Neutropenia
3%
Seizure
3%
Atrial fibrillation
3%
Hypoacusis
3%
Cardiac failure
3%
Dysphagia
3%
Hyponatraemia
3%
Vertigo
3%
Abdominal pain
3%
Malaise
3%
White blood cell count decreased
3%
Hypomagnesaemia
3%
Somnolence
3%
Confusional state
1%
Thrombocytopenia
1%
Hepatotoxicity
1%
Pancreatitis acute
1%
Intestinal obstruction
1%
Generalised oedema
1%
Oesophageal stenosis
1%
Lung abscess
1%
Respiratory tract infection
1%
Hyperkalaemia
1%
Acute kidney injury
1%
Tumour pain
1%
Cerebral ischaemia
1%
Renal failure
1%
Breast pain
1%
Pneumothorax
1%
Leukopenia
1%
Jugular vein thrombosis
1%
Superior vena cava syndrome
1%
Palpitations
1%
Tinnitus
1%
Face oedema
1%
Stomatitis
1%
Herpes zoster
1%
Oropharyngeal pain
1%
Dermatitis acneiform
1%
Pulmonary embolism
1%
Rhinorrhoea
1%
Embolism
1%
Duodenitis
1%
Vascular device occlusion
1%
Hepatitis
1%
Influenza
1%
Medical device site infection
1%
Pneumonia bacterial
1%
Femur fracture
1%
Bone pain
1%
Muscular weakness
1%
Hemiparesis
1%
Aphasia
1%
Cerebral mass effect
1%
Epilepsy
1%
Abdominal discomfort
1%
Hyperthyroidism
1%
Oedema
1%
Chest discomfort
1%
Peripheral swelling
1%
Bronchitis
1%
Fall
1%
Spinal compression fracture
1%
Hypercalcaemia
1%
Hypocalcaemia
1%
Sleep disorder
1%
Dysuria
1%
Paraesthesia
1%
Depression
1%
Hypoaesthesia
1%
Neuropathy peripheral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1a: On-treatment
Cohort 2: On-treatment
Cohort 5b: 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 4 + Cohort 6.2: On-treatment
Cohort 3: Post-treatment Efficacy/Survival Follow-up Period
Cohort 4: Post-treatment Efficacy/Survival Follow-up Period
Cohort 5a: Post-treatment Efficacy/Survival Follow-up Period
Cohort 6.1 (Expansion of Cohort 1a): Post-treatment Efficacy/Survival Follow-up Period
Cohort 7 (Expansion of Cohort 5b): Post-treatment Efficacy/Survival Follow-up Period
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 3: On-treatment
Cohort 4: On-treatment
Cohort 6.1 (Expansion of Cohort 1a): On-treatment
Cohort 5b: On-treatment
Cohort 5b + Cohort 7: On-treatment
All Patients: On-treatment
Cohort 5a: On-treatment
Cohort 1b: Post-treatment Efficacy/Survival Follow-up Period
Cohort 5b + Cohort 7: Post-treatment Efficacy/Survival Follow-up Period
Cohort 1a: Post-treatment Efficacy/Survival Follow-up
Cohort 2: Post-treatment Efficacy/Survival Follow-up Period
Cohort 4 + Cohort 6.2: Post-treatment Efficacy/Survival Follow-up Period
Trial Design
10Treatment groups
Experimental Treatment
Group I: Cohort 7 (expansion of Cohort 5b): Treatment-naïve with MET mutation regardless of MET GCN (1L)Experimental Treatment1 Intervention
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
Group II: Cohort 6.2 (expansion of Cohort 4): Pre-treated patients with MET mutation (2L)Experimental Treatment1 Intervention
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
Group III: Cohort 6.1 (expansion of Cohort 1a): Pre-treated patients MET GCN ≥ 10 without MET mutation (2L)Experimental Treatment1 Intervention
Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
Group IV: Cohort 5b: Treatment-naïve patients with MET mutation regardless of MET GCN (1L)Experimental Treatment1 Intervention
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
Group V: Cohort 5a: Treatment-naïve patients with MET GCN ≥10 (1L)Experimental Treatment1 Intervention
Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
Group VI: Cohort 4: Pre-treated patients with MET mutation regardless of MET GCN (2/3L)Experimental Treatment1 Intervention
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
Group VII: Cohort 3: Pre-treated patients with MET GCN < 4 (2/3L)Experimental Treatment1 Intervention
Pre-treated patients with MET GCN < 4 treated with INC280 at 400mg BID as second or third line (2/3L)
Group VIII: Cohort 2: Pre-treated patients with MET GCN ≥ 4 and < 6 (2/3L)Experimental Treatment1 Intervention
Pre-treated patients with MET GCN ≥ 4 and < 6 treated with INC280 at 400mg BID as second or third line (2/3L)
Group IX: Cohort 1b:Pre-treated patients with MET GCN ≥ 6 and < 10 (2/3L)Experimental Treatment1 Intervention
Pre-treated patients with MET GCN ≥ 6 and < 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
Group X: Cohort 1a: Pre-treated patients with MET GCN ≥ 10 (2/3L)Experimental Treatment1 Intervention
Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capmatinib
2021
Completed Phase 3
~570
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,196,980 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are taking part in this investigation?
"At this time, no patients are currently being recruited for this trial. The study was initiated on June 11th 2015 and the latest update occurred on November 3rd 2022; if you're looking elsewhere, there are 4162 studies actively seeking participants with carcinoma non-small cell lung cancer and 15 trials recruiting volunteers who need to take INC280 (capmatinib)."
Answered by AI
Are there numerous sites within Canada that are presently hosting this clinical experiment?
"Currently, 15 medical centres across the nation are taking part in this clinical trial. These sites include Kansas City, Portland and Allentown to name a few. It is best to choose the closest option available if you wish to curtail travelling expenses when enrolling as a participant."
Answered by AI
Are there still openings available to partake in this experiment?
"Unfortunately, this clinical trial is not presently seeking participants. It was originally posted on June 11th 2015 and its last update occurred November 3rd 2022. Those looking for alternative trials may find it useful to know that there are 4162 studies involving carcinoma non-small-cell lung actively enrolling patients and 15 trials specifically searching for individuals with experience taking INC280 (capmatinib)."
Answered by AI
To what extent is capmatinib potentially hazardous to those who take it?
"The safety of INC280 (capmatinib) is ranked at 2, as it has only been tested in Phase 2 trials. This rating indicates that some evidence exists for its security but no proof of efficacy yet."
Answered by AI
Has this research endeavor been previously explored before?
"Since 2013, Novartis Pharmaceuticals has sponsored research surrounding INC280 (capmatinib). After the inaugural trial which entailed 38 participants in 2013, Phase 2 drug approval was achieved. Nowadays, there are 15 studies ongoing across 130 cities and 39 countries examining this medication's efficacy."
Answered by AI
Are there any extant studies involving INC280 (capmatinib)?
"Currently, 15 trials are actively researching the effectiveness of capmatinib (INC280) with three in Phase 3. Pierre Benite and Aichi contain many clinical trial sites for this drug, though 363 locations across the world offer it."
Answered by AI
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