NCT03539536

Study of an Active Drug in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer

Brief summary

This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that over express c-Met (c-Met+) best suited for an active drug therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2).

Interventional study

Status:
Recruiting
Conditions:
Non Small Cell Lung Cancer
Enrollment:
310 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M14-239
Allocation:
N/A
Intervention model:
Single Group Assignment
Masking:
None (Open Label)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

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.

All the cities where the clinical studies are located

Edmonton - T6G 1Z2
Ottawa - K1H 8L6
Toronto - M5G 2M9
Greenfield Park - J4V 2H1