Offene Studie der Phase II zur Sicherheit und Wirksamkeit von Telisotuzumab Vedotin (ABBV-399) bei Studienteilnehmern mit vorbehandeltem c-Met-positivem nicht kleinzelligem Lungenkarzinom

Drug: Telisotuzumab vedotin

Inclusion Criteria:

- Histologically confirmed non-squamous cell non-small cell lung cancer (NSCLC) with
known epidermal growth factor receptor (EGFR) status (wild type or mutant; with site
documented status). Of note, participants with other actionable mutations are eligible
as long as EGFR status is known and all other eligibility criteria are met.

- Has locally advanced or metastatic NSCLC.

- Has c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC)
laboratory. Participant must submit archival or fresh tumor material for assessment of
c-Met levels during the pre-screening period. If archival tissue is c-Met negative,
participant can submit fresh biopsy material for reassessment of c-Met expression.

- Have received no more than 2 lines of prior systemic therapy (including no more than 1
line of systemic cytotoxic chemotherapy) in the locally advanced or metastatic
setting.

- Multiple lines of tyrosine kinase inhibitors (TKIs) targeting the same gene
alteration count as 1 line of therapy for the purposes of this eligibility
criterion.

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

Exclusion Criteria:

- Have received prior c-Met-targeted antibody-based therapies.

- Has adenosquamous histology.

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

- Has a clinically significant condition(s) described in the protocol.

- Has unresolved clinically significant adverse events >= grade 2 from prior anticancer
therapy, except for alopecia or anemia.

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

- Has received live vaccine within 30 days of the first dose of telisotuzumab vedotin.

- History of interstitial lung disease or pneumonitis that required treatment with
systemic steroids, or any evidence of active interstitial lung disease or pneumonitis.

- Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

- Participants do not have any evidence of pulmonary fibrosis on screening imaging
assessment or any history of pneumonitis or interstitial lung disease within 3 months
of the planned first dose of the study drug.

- Participants must not have received radiation therapy to the lung <6 months prior to
the first dose of telisotuzumab vedotin.