| Eligibility |
Inclusion Criteria:
Patients eligible for inclusion in this Treatment Plan have to meet all of the following
criteria:
1. Age = 18 years
2. Patients with advanced or metastatic MET exon 14 skipping (METex14) NSCLC. In European
Union countries: Patients with advanced or metastatic MET exon 14 skipping (METex14)
NSCLC who have received a prior line of therapy.
3. 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
4. Written patient informed consent must be obtained prior to start of treatment in
accordance with local laws and regulations.
Exclusion Criteria :
Patients eligible for this Treatment Plan must not meet any of the following criteria:
1. Participants with known hypersensitivity to any of the excipients of Capmatinib
(crospovidone, mannitol, microcrystalline cellulose, povidone, sodium lauryl sulfate,
magnesium stearate, colloidal silicon dioxide, and various coating premixes).
2. 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).
3. Thoracic radiotherapy to lung fields = 4 weeks prior to starting Capmatinib 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 Capmatinib or patients who have not recovered from
radiotherapy-related toxicities. Palliative radiotherapy for bone lesions = 2 weeks
prior to starting Capmatinib is allowed.
4. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks
prior (2 weeks for resection of brain metastases) to starting Capmatinib 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
5. Patients receiving treatment with strong inducers of CYP3A4 that cannot be
discontinued at least 1 week prior to the start of treatment with Capmatinib and for
the duration of the treatment
6. Impairment of GI function or GI disease that may significantly alter the absorption of
Capmatinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or
malabsorption syndrome)
7. Unable or unwilling to swallow tablets as per dosing schedule
8. Patients receiving treatment with any enzyme-inducing anticonvulsant that cannot be
discontinued at least 1 week before first dose of Capmatinib, and for the duration of
the treatment. Patients on non-enzyme-inducing anticonvulsants are eligible
9. Other severe, acute, or chronic medical or psychiatric conditions, substance abuse or
laboratory abnormalities that in the opinion of the treating physician may increase
the risk associated with the treatment,
10. Any other condition that would, in the treating physician's judgment, contraindicate
treatment due to safety concerns e.g., active infection (including active hepatitis B
and C, SARS-CoV-2), inflammation, intestinal obstruction, unable to swallow
medication, social/ psychological issues, etc.
11. Participants who received live vaccines (e.g., intranasal influenza, measles, mumps,
rubella, oral polio, BCG, yellow fever, varicella, TY21a typhoid vaccines and COVID 19
vaccines) within 30 days prior to the first dose of study treatment.
12. Pregnant or nursing (lactating) women
13. Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using highly effective methods of contraception
during dosing and for 7 days after stopping treatment. Highly effective contraception
methods include:
- Total abstinence (when this is in line with the preferred and usual lifestyle of
the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal,
postovulation methods) and withdrawal are not acceptable methods of contraception
- Female sterilization (have had surgical bilateral oophorectomy with or without
hysterectomy) total hysterectomy, or tubal ligation at least six weeks before
taking treatment. In case of unilateral oophorectomy, only when the reproductive
status of the woman has been confirmed by follow up hormone level assessment
- Male sterilization (at least 6 months prior to screening). For female subjects on
the program the vasectomized male partner should be the sole partner for that
subject
- Use of oral, injected or implanted hormonal methods of contraception or placement
of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of
hormonal contraception that have comparable efficacy (failure rate <1%), for
example hormone vaginal ring or transdermal hormone contraception. In case of use
of oral contraception women should have been stable on the same pill for a
minimum of 3 months before taking treatment.
Note: Women are considered post-menopausal and not of child bearing potential if they
have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical
profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical
bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six
weeks before program entry. In the case of unilateral oophorectomy, only when the
reproductive status of the woman has been confirmed by follow up hormone level
assessment is she considered not of child bearing potential
14. Sexually active males unless they use a condom during intercourse while taking drug
and for 7 days after stopping treatment and should not father a child in this period.
A condom is required for all sexually active males to prevent them from fathering a
child AND to prevent delivery of capmatininb via seminal fluid to partner. In
addition, male participants must not donate sperm for the time period specified above
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