Official Title
Managed Access Program (MAP) to Provide Access to INC280, for MET Dysregulated Non-Small Cell Lung Cancer (NSCLC)
Brief Summary

The purpose of this Cohort Treatment Plan is to allow access to INC280 for eligible patients diagnosed with MET dysregulated NSCLC. The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations.

Detailed Description

The requesting Treating Physician submitted a request for access to drug (often referred to

as Compassionate Use) to Novartis which was reviewed and approved by the medical team

experienced with the drug and indication.



This program will provide access to patients until:



- All participating countries have received marketing authorization and product is

commercially available and accessible to all participating patient(s) or



- Alternative treatment options are available and/or



- In case of changes in the safety profile or a lack of overall efficacy of the product.

Available
Intermediate-size Population
Carcinoma, Non-Small Cell Lung
Non-Small Cell Lung Cancer
Non-Small-Cell Lung Carcinoma
Nonsmall Cell Lung Cancer

Drug: Capmatinib
Tablet for oral use, dose Up to 400mg, twice daily
Other Name: INC280

Eligibility Criteria

Inclusion Criteria:

Patients eligible for inclusion in this Treatment Plan have to meet all of the following
criteria:

Age ≥ 18 years Patients diagnosed with MET dysregulated NSCLC Patients must have adequate
organ function including the following laboratory values at the program enrollment:
Calculated creatinine clearance (using Cockcroft-Gault formula) ≥ 45 mL/min Total bilirubin
≤ 1.5 x ULN Aspartate transaminase (AST) ≤ 3 x ULN, except for patients with liver
metastasis, who may only be included if AST ≤ 5 x ULN Alanine transaminase (ALT) ≤ 3 x ULN,
except for patients with liver metastasis, who may only be included if ALT ≤ 5 x ULN
Alkaline phosphatase (ALP) ≤ 5.0 x ULN Asymptomatic serum amylase ≤ grade 2. Patients with
grade 1 or grade 2 serum amylase at the beginning of the treatment must be confirmed to
have no signs and/or symptoms suggesting pancreatitis or pancreatic injury (e.g., elevated
P-amylase, abnormal imaging findings of pancreas, etc.) Serum lipase ≤ ULN Patients must
have the following laboratory values within the laboratory normal limits or corrected to
within normal limits with supplements: Potassium, magnesium, phosphorus, total calcium
(corrected for serum albumin) Written patient informed consent must be obtained prior to
start of treatment.

Exclusion Criteria :

Patients with known history of hypersensitivity to any drugs or metabolites of similar
chemical classes as INC280 (crospovidone, mannitol, microcrystalline cellulose, povidone,
sodium lauryl sulfate, magnesium stearate, colloidal silicon dioxide, and various coating
premixes). Presence or history of interstitial lung disease or interstitial pneumonitis,
including clinically significant radiation pneumonitis (i.e., affecting activities of daily
living or requiring therapeutic intervention). Thoracic radiotherapy to lung fields ≤ 4
weeks prior to starting INC280 or patients who have not recovered from radiotherapy-related
toxicities. For all other anatomic sites (including radiotherapy to thoracic vertebrae and
ribs), radiotherapy ≤ 2 weeks prior to starting INC280 or patients who have not recovered
from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions ≤ 2 weeks
prior to starting INC280 is allowed Major surgery (e.g., intra-thoracic, intra-abdominal or
intra-pelvic) within 4 weeks prior (2 weeks for resection of brain metastases) to starting
INC280 or who have not recovered from side effects of such procedure. Video-assisted
thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery and
patients can be enrolled in the program ≥ 1 week after the procedure

*Other protocol-defined inclusion/exclusion criteria may apply

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years~Maximum: 99 Years
Contacts

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Novartis Pharmaceuticals
+41613241111

Novartis Pharmaceuticals
NCT Number
Keywords
Non-small cell lung carcinoma
NSCLC
Treatment of lung cancer
lung cancer
lung adenocarcinoma
Squamous cell lung carcinoma
Large-cell lung carcinoma
Non small cell lung carcinoma
Non Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Large cell lung carcinoma
Large cell lung cancer
MeSH Terms
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Intervention Name
Capmatinib