Tepotinib Phase II in Non-small Cell Lung Cancer (NSCLC) Harboring MET Alterations

Inclusion Criteria:

- Signed, written informed consent by subject or legal representative prior to any
trial-specific screening procedure

- Male or female, greater than or equal to (>=) 18 years of age (or having reached the
age of majority according to local laws and regulations

- Measurable disease in accordance with RECIST version 1.1

- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1

- A female subject is eligible to participate if she is not pregnant, not breastfeeding,
and at least one of the following conditions applies:

- Not a woman of childbearing potential OR

- A woman of childbearing potential who agrees to use a highly effective contraception

- A male subject must agree to use and to have their female partners of childbearing
potential to use a highly effective contraception

- Histologically confirmed advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC)
(all histologies including squamous and sarcomatoid)

- Treatment naïve patients in first-line or pretreated patients with no more than 2
lines of prior therapy

- Subjects with MET alterations, namely METex14 skipping alterations in plasma and/or
tissue, or MET amplification only in plasma and/or tumor biopsy samplet

Exclusion Criteria:

- Subjects with characterized Epidermal Growth Factor Receptor (EGFR) activating
mutations that predict sensitivity to anti-EGFR-therapy

- Subjects with characterized Anaplastic Lymphoma Kinase (ALK) rearrangements that
predict sensitivity to anti-ALK therapy

- Active brain metastases

- Any unresolved toxicity Grade 2 or more according to National Cancer Institute Common
Terminology Criteria for Adverse Events (NCI-CTCAE) from previous anticancer therapy

- Need for transfusion within 14 days prior to the first dose of trial treatment

- Prior chemotherapy, biological therapy, radiation therapy, hormonal therapy for
anti-cancer purposes, targeted therapy, or other investigational anticancer therapy
(not including palliative radiotherapy at focal sites) within 21 days prior to the
first dose of trial treatment;

- Subjects who have brain metastasis as the only measurable lesion

- Inadequate hematological, liver, renal, cardiac function

- Prior treatment with other agents targeting the Hepatocyte Growth Factor c(HGF/c) -Met
pathway

- Hypertension uncontrolled by standard therapies (not stabilized to < 150/90 mmHg)

- Past or current history of neoplasm other than Non-small Cell Lung Cancer (NSCLC),
except for curatively treated non-melanoma skin cancer, in situ carcinoma of the
cervix, or other cancer curatively treated and with no evidence of disease for at
least 5 years

- Medical history of difficulty swallowing, malabsorption, or other chronic
gastrointestinal disease, or conditions that may hamper compliance and/or absorption
of the test product

- Major surgery within 28 days prior to Day 1 of trial treatment

- Known infection with human immunodeficiency virus, or an active infection with
hepatitis B or hepatitis C virus

- Substance abuse, active infection, or other acute or chronic medical or psychiatric
condition or laboratory abnormalities that might increase the risk associated with
trial participation at the discretion of Investigators

- Known hypersensitivity to any of the trial treatment ingredients

- Legal incapacity or limited legal capacity

- Any other reason that, in the opinion of the Principal Investigator, precludes the
subject from participating in the trial

- Participation in another clinical trial within the past 30 days