Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as INC280
Capmatinib · 4 trials · 3 indications
Tumor response was assessed by a blinded independent review committee (BIRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. The primary efficacy endpoint ORR was estimated and the exact 95% confidence interval (CI) was provided by cohort.
A DLT was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.
Percentage of participants with AEs, including changes from baseline in vital signs and laboratory results qualifying and reported as AEs. AEs were assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: Death
Percentage of participants with at least one dose reduction. Dose reductions were only allowed for capmatinib
Percentage of participants with at least one dose interruption. Dose interruptions were allowed for capmatinib and spartalizumab.
The relative dose intensity of capmatinib and spartalizumab is computed as the ratio of dose intensity and planned dose intensity, multiplied by 100.
OS is defined as the time from date of start of treatment to date of death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date patient alive. Results are not available because randomized part never started.
Collection of adverse events and serious adverse events at every visit. Safety assessment will be performed and include local laboratory test monitoring in addition to local standard of care assessments.
Percentage of participants with a best overall response defined as confirmed complete response (CR) or partial response (PR) by BIRC assessment per RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Treatment Naive participants |
| Cohort 2 | EXPERIMENTAL | Participants received one or two prior lines of treatment |
| Run-in part: capmatinib + spartalizumab | EXPERIMENTAL | Participants (enrolled in the run-in part) were treated with capmatinib 400 mg twice daily (BID) and spartalizumab 400 mg intravenously (i.v.) once every 28 days |
| Randomized part: capmatinib+spartalizumab | EXPERIMENTAL | Participants (enrolled in the randomized part) treated with capmatinib 400 mg twice daily (BID) and spartalizumab 400 mg intravenously (i.v.) once every 28 days |
| Randomized part: docetaxel | ACTIVE_COMPARATOR | Participants (enrolled in the randomized part) treated with docetaxel 75mg/m2 i.v. following local guidelines as per standard of care and product labels once every 21 days |
| Capmatinib | EXPERIMENTAL | Starting dose of study treatment for patients in this protocol should be the same as the dose provided in the parent protocol at the time when the rollover protocol is initiated. Dose modifications are permitted. |
| Capmatinib + Nazartinib | EXPERIMENTAL | Starting dose of the study treatment for patients should be the same as the dose provided in the parent protocol at the time when the rollover protocol is initiated. Dose modifications are permitted. |
| Capmatinib + Gefitinib | EXPERIMENTAL | Starting dose of the study treatment for patients in this protocol should be the same as the dose provided in the parent protocol at the time when the rollover protocol is initiated. Dose modifications are permitted. |
| Capmatinib + Osimertinib | EXPERIMENTAL | Starting dose of the study treatment for patients in this protocol should be the same as the dose provided in the parent protocol at the time when the rollover protocol is initiated. Dose modifications are permitted. |
| Cohort 1a: Pre-treated patients with MET GCN ≥ 10 (2/3L) | EXPERIMENTAL | Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L) |
| Cohort 1b:Pre-treated patients with MET GCN ≥ 6 and < 10 (2/3L) | EXPERIMENTAL | Pre-treated patients with MET GCN ≥ 6 and \< 10 treated with INC280 at 400 mg BID as second or third line (2/3L) |
| Cohort 2: Pre-treated patients with MET GCN ≥ 4 and < 6 (2/3L) | EXPERIMENTAL | Pre-treated patients with MET GCN ≥ 4 and \< 6 treated with INC280 at 400mg BID as second or third line (2/3L) |
| Cohort 3: Pre-treated patients with MET GCN < 4 (2/3L) | EXPERIMENTAL | Pre-treated patients with MET GCN \< 4 treated with INC280 at 400mg BID as second or third line (2/3L) |
| Cohort 4: Pre-treated patients with MET mutation regardless of MET GCN (2/3L) | EXPERIMENTAL | Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L) |
| Cohort 5a: Treatment-naïve patients with MET GCN ≥10 (1L) | EXPERIMENTAL | Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L) |
| Cohort 5b: Treatment-naïve patients with MET mutation regardless of MET GCN (1L) | EXPERIMENTAL | Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) |
| Cohort 6.1 (expansion of Cohort 1a): Pre-treated patients MET GCN ≥ 10 without MET mutation (2L) | EXPERIMENTAL | 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) |
| Cohort 6.2 (expansion of Cohort 4): Pre-treated patients with MET mutation (2L) | EXPERIMENTAL | 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) |
| Cohort 7 (expansion of Cohort 5b): Treatment-naïve with MET mutation regardless of MET GCN (1L) | EXPERIMENTAL | 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) |
| Name | Type | Description |
|---|---|---|
| Capmatinib | DRUG | 400 mg of capmatinib tablets, administered orally twice daily |
| Spartalizumab | DRUG | Spartalizumab 400 mg via intravenous infusion once every 28 days |
| Docetaxel | DRUG | Docetaxel 75mg/m2 i.v. following local guidelines as per standard of care and product labels once every 21 days |
| Nazartinib | DRUG | Capsule for oral use; 25 mg, 50 mg; once a day |
| Gefitinib | DRUG | tablets for oral use; 250mg; once a day |
| Osimertinib | DRUG | Tablets for oral use; 40 mg, 80 mg; once a day. |
Key Inclusion Criteria: * Chinese adult ≥ 18 years old at the time of informed consent * Histologically confirmed stage IIIB, IIIC or IV NSCLC at the time of study entry, not amenable to curative surgery or radiation or multi-modality therapy (according to staging definition in CSCO guidelines for ...
Capmatinib is an investigational small molecule being studied for the treatment of non-small cell lung cancer, solid tumors, advanced solid tumors that are cMET-dependent, and hepatic impairment. It is also being evaluated in patients with cMET dysregulation advanced solid tumors. The drug is in Phase 2 clinical development.
Capmatinib is a kinase inhibitor, belonging to the -tinib class of drugs. It targets the cMET pathway, as indicated by its use in cMET-dependent and cMET dysregulation advanced solid tumors. The drug is designed to inhibit this specific kinase to potentially treat certain cancers.
Capmatinib is developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the drug's safety and efficacy in various oncology indications.
Capmatinib is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is studying the drug in patients with advanced solid tumors that are cMET-dependent.
Capmatinib has been studied in several clinical trials. NCT02414139 is a completed Phase 2 study in non-small cell lung cancer. NCT02474537 is a completed Phase 1 study in hepatic impairment. NCT03040973 is an active Phase 2 trial in cMET-dependent advanced solid tumors. NCT03647488 is a completed Phase 2 study in non-small cell lung cancer.
Yes, Capmatinib is also known as INC280. Clinical trials have used both names to refer to the same drug. For example, the study NCT02414139 is titled 'Study of Oral cMET Inhibitor INC280' and investigates the drug Capmatinib in patients with non-small cell lung cancer.