Clinical Trials

Inclusion Criteria:

- Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as
assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the
VENTANA MET (SP44) RxDx assay.

- Archival or fresh tumor material must be submitted for assessment of c-Met levels
during the Pre-Screening period. Tumor material from the primary tumor site and/or
metastatic sites are allowed.

- If a participant was prescreened for Study M14-239 but did not enroll, tumor
material previously submitted for Study M14-239 may be used for Study M18-868
Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor
material is available (Except China).

- A histologically documented non-squamous cell NSCLC that is locally advanced or
metastatic.

- A known epidermal growth factor receptor (EGFR) activating mutation status.

- Actionable alterations in genes other than EGFR .

- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version
1.1.

- An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

- Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the
locally advanced or metastatic setting.

- Neoadjuvant and adjuvant systemic cytotoxic chemotherapy will count as a prior
line for eligibility purposes if progression occurred within 6 months of the end
of therapy.

- Have progressed on at least 1 line of prior therapy for locally advanced/metastatic
NSCLC:

- Participants WITHOUT an actionable gene alteration: must have progressed on (or
be considered ineligible for) platinum-based chemotherapy and immune checkpoint
inhibitor (as monotherapy or in combination with chemotherapy).

- Participants WITH an actionable gene alteration for which immune checkpoint
inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase [ALK]
translocation): must have progressed on (or be considered ineligible for)
anti-cancer therapy targeting driver gene alterations and platinum-based
chemotherapy.

- Participants with actionable gene alterations for which immune checkpoint
inhibitor is standard of care must have also progressed on (or be considered
ineligible for) immune checkpoint inhibitor (as monotherapy or in
combination with chemotherapy).

- Must be considered appropriate for docetaxel therapy based on the assessment of the
treating physician.

- Participants with metastases to the central nervous system (CNS) are eligible only
after definitive therapy (such as surgery or radiotherapy) is provided and:

- There is no evidence of progression of CNS metastases at least 2 weeks after
definitive therapy.

- They are asymptomatic and off or on a stable or reducing dose of systemic
steroids and/or anticonvulsants for at least 2 weeks prior to first dose of
telisotuzumab vedotin.

Exclusion Criteria:

- Participants with adenosquamous histology.

- Actionable epidermal growth factor receptor (EGFR) activating mutations.

- Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab
vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of
monomethylauristatin E..

- Participants who have received prior docetaxel therapy.

- A history of other malignancies except:

- Malignancy treated with curative intent and with no known active disease present
for >=2 years before the first dose of study drug and felt to be at low risk for
recurrence by investigator.

- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
of disease.

- Adequately treated carcinoma in situ without current evidence of disease.

- A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of
active pneumonitis on screening chest computed tomography (CT) scan. A history of
prior radiation pneumonitis in the radiation field (fibrosis) is permitted.

- Unresolved adverse event (AE) >= Grade 2 from prior anticancer therapy, except for
alopecia or anemia.

- Major surgery within 21 days prior to the first dose of telisotuzumab vedotin.

- Clinically significant condition(s) as listed in the protocol.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/7/23.  Questions regarding updates should be directed to the study team contact.