Phase 3 Open-Label, Randomized, Controlled, Global Study in Subjects with Previously Treated c-Met+, EGFR Wildtype, Locally Advanced/Metastatic Nsclc ; with Previously Treated c-Met+, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous

Inclusion criteria (let op korte versie, zie full protocol voor details)

1. Informed Consent
2. Adult at least 18 years old.
3. Subject must have c-Met overexpressing NSCLC as assessed by an AbbVie designated IHC laboratory (see Operations Manual Section 1).
4. Subject has adequate bone marrow, renal, and hepatic function as follows:

• Bone marrow: absolute neutrophil count (ANC) > 1,500/mm3, platelets ≥ 100,000/mm3; hemoglobin ≥ 9.0 g/dL.
• Renal function: serum creatinine ≤ 1.5 × the Institution's upper limit of normal (ULN) range or creatinine clearance (CrCl) ≥ 50 mL/min measured by 24-hour
• Hepatic function: bilirubin ≤ 1.0 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × the ULN, and albumin ≥ 3.0 g/dL.
• Hepatic function for subjects with liver metastases: bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 5.0 × ULN, and albumin ≥ 3.0 g/dL.

6. Subject must have histologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
7. Subject must not have adenosquamous histology.
8. Subjects must have a known EGFR activating mutation status.

• Subjects with actionable EGFR activating mutations are not eligible.

10. Subjects with actionable alterations in genes other than EGFR are eligible.
11. Subject must have measurable disease per RECIST version 1.1.
12. Subject must have an ECOG Performance Status of 0 to 1.
13. Subject must have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.
14. Subject must have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC:
15. Subject must not have received prior c-Met-targeted antibodies.
16. Subject must not have received prior docetaxel therapy.
17. Subject must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
18. Subjects with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided.
19. Subjects must not have a history of other malignancies except:
20. Subject must not have 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 CT scan.
21. Subject must not have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
22. Subjects must not have the following:

• Known human immunodeficiency virus (HIV) infection.
• Active hepatitis B virus (HBV) infection
• Active hepatitis C virus (HCV) infection
• Uncontrolled autoimmune disease.

25. Subject must not have clinically significant condition(s) including but not limited to the following:

• Clinically significant vascular disease, including:
• Myocardial infarction within 1 year or stroke within 6 months prior to first dose of study drug, or unstable or uncontrolled disease/condition related to or affecting cardiac function
• Active uncontrolled bacterial or viral infection.
• Active corneal disorder

26. Subject must not have psychiatric illness/social situation that would limit compliance with the study.
27. Subject must not have a history of major immunologic reaction to any immunoglobulin G (IgG)-containing agent. Subject must not have hypersensitivity to docetaxel or polysorbate 80.
28. Treatment with any of the following therapies does not require a washout period:

• Palliative radiation therapy for bone, skin, or subcutaneous metastases for 10 fractions or less.

29. Subjects must not have had radiation therapy to the lung within 6 months prior to the first dose of study drug and until study drug is permanently discontinued.