Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
AbbVie (Voir sur ClinicalTrials)
octobre 2018
octobre 2025
19 octobre 2024
This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC)
population(s) that overexpress c-Met (c-Met+) best suited for telisotuzumab vedotin
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). After the
Stage 2 global enrollment is completed, an additional cohort at an alternate dose level
will evaluate the safety and efficacy of telisotuzumab vedotin (Stage 3).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Christos CHOUAID | 29/03/2024 01:29:37 | Contacter | ||
| CLCC INSTITUT CURIE | 04/09/2024 13:49:48 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | David PLANCHARD | 19/02/2024 13:08:38 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHM - Hopital Nord /ID# 209854 - 13015 - Marseille - Bouches-du-Rhone - France | Contact (sur clinicalTrials) | ||||
| Centre Leon Berard /ID# 205107 - 69373 - Lyon CEDEX 08 - Rhone - France | Contact (sur clinicalTrials) | ||||
| CHI Toulon-La Seyne sur Mer /ID# 230545 - 83056 - Toulon - France | Contact (sur clinicalTrials) | ||||
| CHU Lille - Hôpital Albert Calmette /ID# 205105 - 59037 - Lille - Hauts-de-France - France | Contact (sur clinicalTrials) | ||||
| CHU Strasbourg - Hopital Civil /ID# 208080 - 67091 - Strasbourg cedex - France | Contact (sur clinicalTrials) | ||||
| HCL - Hopital Louis Pradel /ID# 216209 - 69500 - Bron - Rhone - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie /ID# 216207 - 33000 - Bordeaux - Gironde - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Have locally advanced or metastatic non-small cell lung cancer (NSCLC).
- Have 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 prescreening period. Tumor material from the primary
tumor site and/or metastatic sites are allowed. If archival tissue is negative for
c-Met overexpression, subject can submit fresh biopsy material for reassessment of
c-Met expression.
- Histologically documented non-squamous epidermal growth factor receptor (EGFR) wild
type NSCLC (site documented EGFR status). Of note, subjects with other actionable
mutations are eligible as long as EGFR status is known and all other eligibility
criteria are met. As of Protocol Version 11, Stage 1 is complete and Stage 2 is
enrolling participants with non-squamous EGFR wild type NSCLC only.
- Must 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 tyrosine
kinase (TK) count as 1 line of therapy for the purposes of this eligibility
criterion.
- Progressed on systemic cytotoxic therapy (or are ineligible for systemic cytotoxic
chemotherapy) and an immune checkpoint inhibitor (as monotherapy or in combination
with systemic cytotoxic chemotherapy, or ineligible), and prior anticancer therapies
targeting driver gene alterations (if applicable).
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- Treatment with any therapies within the noted time intervals is excluded prior to
the first dose of telisotuzumab vedotin as noted in the protocol.
- Metastases to the central nervous system (CNS) are eligible only after definitive
therapy (such as surgery or radiotherapy) is provided within the protocol.
- Have locally advanced or metastatic non-small cell lung cancer (NSCLC).
- Have 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 prescreening period. Tumor material from the primary
tumor site and/or metastatic sites are allowed. If archival tissue is negative for
c-Met overexpression, subject can submit fresh biopsy material for reassessment of
c-Met expression.
- Histologically documented non-squamous epidermal growth factor receptor (EGFR) wild
type NSCLC (site documented EGFR status). Of note, subjects with other actionable
mutations are eligible as long as EGFR status is known and all other eligibility
criteria are met. As of Protocol Version 11, Stage 1 is complete and Stage 2 is
enrolling participants with non-squamous EGFR wild type NSCLC only.
- Must 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 tyrosine
kinase (TK) count as 1 line of therapy for the purposes of this eligibility
criterion.
- Progressed on systemic cytotoxic therapy (or are ineligible for systemic cytotoxic
chemotherapy) and an immune checkpoint inhibitor (as monotherapy or in combination
with systemic cytotoxic chemotherapy, or ineligible), and prior anticancer therapies
targeting driver gene alterations (if applicable).
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- Treatment with any therapies within the noted time intervals is excluded prior to
the first dose of telisotuzumab vedotin as noted in the protocol.
- Metastases to the central nervous system (CNS) are eligible only after definitive
therapy (such as surgery or radiotherapy) is provided within the protocol.
- Have received radiation therapy to the lungs < 6 months prior to the first dose of
telisotuzumab vedotin.
- Have received any live vaccine within 30 days of the first dose of investigational
product.
- Has adenosquamous histology.
- Have a history of other malignancies except those noted within the protocol.
- Have a history of interstitial lung disease (ILD) or pneumonitis that required
treatment with systemic steroids.
- Have any evidence of pulmonary fibrosis on screening imaging assessment or any
history of pneumonitis or ILD within 3 months of the planned first dose of the study
drug (Except for Sites in Ireland). For imaging findings deemed clinically
insignificant by the treating physician, subject may be eligible after discussion
with and approval from the AbbVie medical monitor.
- For Sites in Ireland Only: Must not have any evidence of pulmonary fibrosis on
screening imaging assessment or any history of pneumonitis or ILD. For imaging
findings deemed clinically insignificant by the treating physician, subject may be
eligible after discussion with and approval from the AbbVie medical monitor.
- Have a clinically significant condition(s) as noted in the protocol.
- Have unresolved clinically significant adverse events of Grade >= 2 from prior
anticancer therapy, except for alopecia or anemia.
- Have had major surgery within 21 days prior to the first dose of telisotuzumab
vedotin.
- For Sites in France and Czech Republic Only: Have the following:
- Known human immunodeficiency virus (HIV) infection. Note: HIV testing is not
required for eligibility for this protocol unless mandated by local regulatory
authority or ethics committee/institutional review board.
- Active hepatitis B virus (HBV) infection, defined by hepatitis B surface
antigen (HBsAg) positivity or HBV DNA >= 500 IU/mL. In participants with known
HBV infection, the presence of active infection must be tested locally. If HBV
status is unknown, it must be tested locally at screening.
- Active hepatitis C virus (HCV) infection, defined by HCV ribonucleic acid (RNA)
positivity. Participants cured of HCV infection may be included in the study.
In participants with known HCV infection, the presence of active infection must
be tested locally. If HCV status is unknown, it must be tested locally at
screening.
- Uncontrolled autoimmune disease.