Study of Capmatinib in Indian Patients With MET Exon 14 Skipping Mutation Positive Advanced NSCLC.

Inclusion Criteria:

1. Signed informed consent form (ICF) must be obtained prior to participation in the
study.

2. Adult ≥18 years old at the time of informed consent.

3. Stage IIIB/IIIC (not amenable to surgery, radiation or multi-modality therapy) or
Stage IV NSCLC (according to Version 8 of the AJCC Staging Manual) either treatment
naive or progressed on 1 or more lines of therapy at the time of study entry.

4. Histologically or cytologically confirmed diagnosis of NSCLC with confirmed EGFR
wild-type and ALK rearrangement negative and who have tested positive test for MET
exon14 skipping mutation (Locally available MET report either by RT-PCR or Next
Generation Sequencing [NGS] would be considered, in case not available MET testing
would be done through NGS based platform during molecular pre-screening done as part
of the study).

5. Patients must have recovered from all toxicities related to prior systemic therapies
to grade ≤1 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0).

6. At least one measurable lesion as defined by Response Evaluation Criteria in Solid
Tumors (RECIST) 1.1.

7. Patients must have adequate organ function including the following laboratory values
at the screening visit:

- Absolute neutrophil count ≥1.5 x 109/L without growth factor support

- Platelets ≥100 x 109/L

- Hemoglobin ≥9 g/dL

- Calculated creatinine clearance (using Cockcroft-Gault formula) ≥45 mL/min

- Total bilirubin ≤1.5 upper limit of normal (ULN) (except in patients with
Gilbert's syndrome, who may be included if total bilirubin is ≤3.0 x ULN and
direct bilirubin is ≤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 ≤5.0 x ULN

- Asymptomatic serum amylase ≤ grade 2. Patients with grade 1 or grade 2 serum
amylase at the beginning of the study 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.

8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.

9. Willing and able to comply with scheduled visits, treatment plan, and laboratory
tests.

Exclusion Criteria:

1. Prior treatment with any MET inhibitor or hepatocyte growth factor -targeting
therapy.

2. Presence or history of a malignant disease other than NSCLC that has been diagnosed
and/or required therapy within the past 3 years. Exceptions to this exclusion
include the following: completely resected basal cell and squamous cell skin cancers
and completely resected carcinoma in situ of any type

3. Patients with symptomatic central nervous system (CNS) metastases who are
neurologically unstable or have required increasing doses of steroids within the 2
weeks prior to study entry to manage CNS symptoms.

4. Patients with known druggable molecular alterations (such as ROS1 translocation or
BRAF mutation, etc.) which might be a candidate for alternative targeted therapies
as applicable per local regulations and treatment guidelines.

5. 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).

6. Patients with clinically significant heart diseases like unstable angina/acute
myocardial infarction within 6 months prior to screening, NYHA class III-IV
congestive cardiac failure, uncontrolled hypertension, arrhythmias or QTcF≥470 ms on
the screening electrocardiogram (ECG)

7. 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
and mediastinoscopy will not be counted as major surgery and patients can be
enrolled in the program ≥1 week after the procedure

8. 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.

9. Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of capmatinib or patients who are unable to swallow oral
tablets.

10. Patients receiving treatment with strong inducers of CYP3A that cannot be
discontinued at least 1 week prior to the start of treatment with capmatinib and for
the duration of the study

11. Unable or unwilling to swallow tablets as per dosing schedule

12. Patients with known hypersensitivity to capmatinib and any of the excipients of
capmatinib.

13. Patients with any other severe, acute or chronic medical or psychotic conditions or
significant abnormal physical findings that in the opinion of the investigator may
increase the risk associated with study participation or that may interfere with the
interpretation of study results.

14. Previous (within 28 days) or concomitant participation in another clinical study
with investigational medicinal product(s).

15. Pregnant or nursing (lactating) women.

16. Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using highly effective methods of contraception
while taking study treatment and for 7 days after stopping study treatment. Highly
effective contraception methods include:

- Total abstinence (when this is in line with the preferred and usual lifestyle
of the patient. Note that periodic abstinence (e.g. calendar, ovulation,
symptothermal, post-ovulation methods) and withdrawal are not considered highly
effective and therefore not acceptable methods of contraception.

- Female sterilization (have had surgical bilateral oophorectomy with or without
hysterectomy), total hysterectomy, or bilateral tubal ligation at least six
weeks before taking study treatment. In case of oophorectomy alone, 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 patients
on the study, the vasectomized male partner should be the sole partner for that
patient

- Use of oral, (estrogen and progesterone), injected, or implanted hormonal
methods of contraception or placement of an intrauterine device or intrauterine
system, 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.

17. Sexually active males unwilling to use a condom during intercourse while taking
study treatment and for 7 days after stopping study treatment. A condom is required
for all sexually active male patients to prevent them from fathering a child AND to
prevent delivery of study treatment via seminal fluid to their partner. In addition,
male patients must not donate sperm for the time period specified above.

18. Any other condition that would, in the Investigator's judgment, contraindicate
patient's participation in the clinical study due to safety concerns or compliance
with clinical study procedures, e.g., active infection (including active hepatitis B
and C, SARS-CoV-2), inflammation, intestinal obstruction, unable to swallow
medication, social/ psychological issues, etc.