Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung Cancer
- Conditions
- advanced or metastisc lungcancerNon small cell lung cancersquamous or non squamous10038666
- Registration Number
- NL-OMON52936
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 5
• Histologically confirmed non-small cell lung cancer (NSCLC) with known
epidermal growth factor receptor (EGFR) status (wild type; with site documented
status). Subjects in Monotherapy Cohort 1.6 mg/kg Q2W must have non-squamous
EGFR wild type NSCLC.
• Has locally advanced or metastatic NSCLC.
• Has c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry
(IHC) laboratory. Subject must submit archival or fresh tumor material for
assessment of c-Met levels during the prescreening period. Tumor material from
the primary tumor site and/or metastatic sites are allowed. If archival tissue
is negative for c-Met overexpression, fresh biopsy material may be submitted
for reassessment of c-Met expression.
•If a subject meets eligibility criteria for c-Met protein expression level
based on archival tumor material, fresh tumor material for assessment of c-Met
expression levels should be submitted prior to dosing of
telisotuzumab vedotin. If it is determined that a pre-dose fresh biopsy is not
appropriate for a given subject, the subject may still be enrolled at the
investigator's discretion. AbbVie must be informed of this decision before
dosing.
• Subjects who have progressed on systemic cytotoxic chemotherapy (or are
ineligible for systemic cytotoxic chemotherapy) and an immune checkpoint
inhibitor (as monotherapy or in combination with systemic cytotoxic
chemotherapy, or ineligible for an immune checkpoint inhibitor), and prior
anti-cancer therapies targeting driver gene alterations (if applicable).
• Subject must have received no more than 2 lines of prior systemic therapy
(including no more than 1 line of prior systemic cytotoxic chemotherapy) in the
locally advanced or metastatic setting.
• Subjects should not have received prior cMET-targeted antibody therapies.
• Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
• No known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
infection. If a subject has signs/symptoms suggestive of SARS-CoV-2 infection,
the subject must have a negative molecular (e.g., polymerase chain reaction
[PCR]) test result or 2 negative antigen test results at least 24 hours apart.
• Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be
screen failed and may only rescreen after they meet the following SARS-CoV-2
infection viral clearance criteria:
- At least 10 days since first positive PCR test result have passed in
asymptomatic patients or 10 days since recovery, defined as resolution of fever
without use of antipyretics and improvement
in symptoms.
• Has adenosquamous histology.
• Has received anti-cancer therapy including chemotherapy, radiation therapy,
immunotherapy, biologic, or any investigational therapy as described in the
protocol.
• Subjects 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 4 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.
• 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.
• Subject must not have a history of interstitial lung disease or pneumonitis
that required treatment with systemic steroids.
• Subjects must 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. For imaging
findings deemed clinically insignificant by the treating physician, subject may
be eligible after discussion with and approval from the AbbVie medical monitor.
• Subjects must not have received radiation therapy to the lung <6 months prior
to the first dose of telisotuzumab vedotin.
• Subjects must not have received any live vaccine within 30 days of the first
dose of investigational product.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to determine the overall response rate (ORR) of<br /><br>Telisotuzumab Vedotin in participants with c-Met+ NSCLC.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objectives are to determine:<br /><br>• Duration of response (DoR)<br /><br>• Disease control rate (DCR)<br /><br>• Progression Free Survival (PFS)<br /><br>• Overall Survival (OS)<br /><br><br /><br>For the additional monotherapy cohort<br /><br>Secondary objective is to evaluate the preliminary efficacy of telisotuzumab<br /><br>vedotin monotherapy </p><br>