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 thestudy.

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

3. Stage IIIB/IIIC (not amenable to surgery, radiation or multi-modality therapy) orStage IV NSCLC (according to Version 8 of the AJCC Staging Manual) either treatmentnaive 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 EGFRwild-type and ALK rearrangement negative and who have tested positive test for METexon14 skipping mutation (Locally available MET report either by RT-PCR or NextGeneration Sequencing [NGS] would be considered, in case not available MET testingwould be done through NGS based platform during molecular pre-screening done as partof the study).

5. Patients must have recovered from all toxicities related to prior systemic therapiesto 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 SolidTumors (RECIST) 1.1.

7. Patients must have adequate organ function including the following laboratory valuesat 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 withGilbert's syndrome, who may be included if total bilirubin is ≤3.0 x ULN anddirect bilirubin is ≤1.5 x ULN))

• Aspartate transaminase (AST) ≤3 x ULN, except for patients with livermetastasis, 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 serumamylase at the beginning of the study must be confirmed to have no signs and/orsymptoms suggesting pancreatitis or pancreatic injury (e.g., elevatedP-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 laboratorytests.

Exclusion Criteria:

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

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

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

4. Patients with known druggable molecular alterations (such as ROS1 translocation orBRAF mutation, etc.) which might be a candidate for alternative targeted therapiesas 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 activitiesof daily living or requiring therapeutic intervention).

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

7. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeksprior (2 weeks for resection of brain metastases) to starting capmatinib or who havenot recovered from side effects of such procedure. Video-assisted thoracic surgeryand mediastinoscopy will not be counted as major surgery and patients can beenrolled in the program ≥1 week after the procedure

8. Thoracic radiotherapy to lung fields ≤4 weeks prior to starting capmatinib orpatients who have not recovered from radiotherapy-related toxicities. For all other anatomic sites (including radiotherapy to thoracic vertebrae andribs), radiotherapy ≤2 weeks prior to starting capmatinib or patients who have notrecovered from radiotherapy-related toxicities. Palliative radiotherapy for bonelesions ≤2 weeks prior to starting capmatinib is allowed.

9. Impairment of gastrointestinal (GI) function or GI disease that may significantlyalter the absorption of capmatinib or patients who are unable to swallow oraltablets.

10. Patients receiving treatment with strong inducers of CYP3A that cannot bediscontinued at least 1 week prior to the start of treatment with capmatinib and forthe 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 ofcapmatinib.

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

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

15. Pregnant or nursing (lactating) women.

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

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

• Female sterilization (have had surgical bilateral oophorectomy with or withouthysterectomy), total hysterectomy, or bilateral tubal ligation at least sixweeks before taking study treatment. In case of oophorectomy alone, only whenthe reproductive status of the woman has been confirmed by follow-up hormonelevel assessment.

• Male sterilization (at least 6 months prior to screening). For female patientson the study, the vasectomized male partner should be the sole partner for thatpatient

• Use of oral, (estrogen and progesterone), injected, or implanted hormonalmethods of contraception or placement of an intrauterine device or intrauterinesystem, or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormonecontraception. In case of use of oral contraception women should have beenstable 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 takingstudy treatment and for 7 days after stopping study treatment. A condom is requiredfor all sexually active male patients to prevent them from fathering a child AND toprevent 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, contraindicatepatient's participation in the clinical study due to safety concerns or compliancewith clinical study procedures, e.g., active infection (including active hepatitis Band C, SARS-CoV-2), inflammation, intestinal obstruction, unable to swallowmedication, social/ psychological issues, etc.