Informations générales (source: ClinicalTrials.gov)
A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
Interventional
Phase 3
AbbVie (Voir sur ClinicalTrials)
mars 2022
mars 2028
17 octobre 2024
Cancer is a condition where cells in a specific part of body grow and reproduce
uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which
cancer cells form in the tissues of the lung. The purpose of this study is to determine
if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab
vedotin is in adult participants with NSCLC who have previously been treated. Change in
disease activity and adverse events will be assessed.
Telisotuzumab vedotin is an investigational drug being developed for the treatment of
NSCLC. Participants will be randomly assigned a treatment of Teliso-V or Docetax at an
1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV
infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing
NSCLC will be enrolled in the study in approximately 300 sites worldwide.
Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3
weeks until meeting study drug discontinuation criteria.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital
or clinic. The effect of the treatment will be checked by medical assessments, blood
tests, checking for side effects and completing questionnaires.
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 | 19/04/2024 09:44:05 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Tenon | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT CURIE | Contact (sur clinicalTrials) | ||||
| 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# 251935 - 13015 - Marseille - Bouches-du-Rhone - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Bordeaux /ID# 244953 - 33604 - Pessac CEDEX - Gironde - France | Contact (sur clinicalTrials) | ||||
| CHU Lille - Hôpital Albert Calmette /ID# 251934 - 59037 - Lille - Hauts-de-France - France | Contact (sur clinicalTrials) | ||||
| Hopital Arnaud de Villeneuve /ID# 239404 - 34295 - Montpellier Cedex 5 - Herault - France | Contact (sur clinicalTrials) | ||||
| Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 251933 - 69500 - Bron - Rhone - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Projected life expectancy of at least 12 weeks.
- Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as
assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the
VENTANA MET (SP44) RxDx assay.
- Archival or fresh tumor material must be submitted for assessment of c-Met levels
during the Pre-Screening period. Tumor material from the primary tumor site and/or
metastatic sites are allowed.
- If a participant was prescreened for Study M14-239 but did not enroll, tumor
material previously submitted for Study M14-239 may be used for Study M18-868
Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor
material is available (Except China).
- A histologically or cytologically documented non-squamous cell NSCLC that is locally
advanced or metastatic.
- A known epidermal growth factor receptor (EGFR) activating mutation status.
- Actionable alterations in genes other than EGFR .
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version
1.1.
- An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the
locally advanced or metastatic setting.
- Neoadjuvant and adjuvant systemic cytotoxic chemotherapy will count as a prior
line for eligibility purposes if progression occurred within 6 months of the
end of therapy.
- Have progressed on at least 1 line of prior therapy for locally advanced/metastatic
NSCLC:
- Participants WITHOUT an actionable gene alteration: must have progressed on (or
be considered ineligible for) platinum-based chemotherapy and immune checkpoint
inhibitor (as monotherapy or in combination with chemotherapy).
- Participants WITH an actionable gene alteration for which immune checkpoint
inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase
[ALK] translocation): must have progressed on (or be considered ineligible for)
anti-cancer therapy targeting driver gene alterations and platinum-based
chemotherapy.
- Participants with actionable gene alterations for which immune checkpoint
inhibitor is standard of care must have also progressed on (or be
considered ineligible for) immune checkpoint inhibitor (as monotherapy or
in combination with chemotherapy).
- Must be considered appropriate for docetaxel therapy based on the assessment of the
treating physician.
- Participants with metastases to the central nervous system (CNS) are eligible only
after adequate treatment (such as surgery, radiotherapy, or drug therapy) is
provided and:
- They are asymptomatic and off or on a stable or reducing dose of systemic
steroids (on no more than 10 mg per day [QD] prednisone or equivalent) and/or
anticonvulsants for at least 2 weeks prior to randomization.
- Projected life expectancy of at least 12 weeks.
- Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as
assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the
VENTANA MET (SP44) RxDx assay.
- Archival or fresh tumor material must be submitted for assessment of c-Met levels
during the Pre-Screening period. Tumor material from the primary tumor site and/or
metastatic sites are allowed.
- If a participant was prescreened for Study M14-239 but did not enroll, tumor
material previously submitted for Study M14-239 may be used for Study M18-868
Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor
material is available (Except China).
- A histologically or cytologically documented non-squamous cell NSCLC that is locally
advanced or metastatic.
- A known epidermal growth factor receptor (EGFR) activating mutation status.
- Actionable alterations in genes other than EGFR .
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version
1.1.
- An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the
locally advanced or metastatic setting.
- Neoadjuvant and adjuvant systemic cytotoxic chemotherapy will count as a prior
line for eligibility purposes if progression occurred within 6 months of the
end of therapy.
- Have progressed on at least 1 line of prior therapy for locally advanced/metastatic
NSCLC:
- Participants WITHOUT an actionable gene alteration: must have progressed on (or
be considered ineligible for) platinum-based chemotherapy and immune checkpoint
inhibitor (as monotherapy or in combination with chemotherapy).
- Participants WITH an actionable gene alteration for which immune checkpoint
inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase
[ALK] translocation): must have progressed on (or be considered ineligible for)
anti-cancer therapy targeting driver gene alterations and platinum-based
chemotherapy.
- Participants with actionable gene alterations for which immune checkpoint
inhibitor is standard of care must have also progressed on (or be
considered ineligible for) immune checkpoint inhibitor (as monotherapy or
in combination with chemotherapy).
- Must be considered appropriate for docetaxel therapy based on the assessment of the
treating physician.
- Participants with metastases to the central nervous system (CNS) are eligible only
after adequate treatment (such as surgery, radiotherapy, or drug therapy) is
provided and:
- They are asymptomatic and off or on a stable or reducing dose of systemic
steroids (on no more than 10 mg per day [QD] prednisone or equivalent) and/or
anticonvulsants for at least 2 weeks prior to randomization.
- Evidence of new, untreated CNS metastases.
- Evidence of leptomeningeal disease.
- Participants with adenosquamous or neuroendocrine histology, nor sarcomatoid
features.
- Actionable epidermal growth factor receptor (EGFR) activating mutations.
- Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab
vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of
monomethylauristatin E..
- Participants who have received prior docetaxel therapy.
- A history of other malignancies except:
- Malignancy treated with curative intent and with no known active disease
present for >=2 years before the first dose of study drug and felt to be at low
risk for recurrence by investigator.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
of disease.
- Adequately treated carcinoma in situ without current evidence of disease.
- 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 computed tomography (CT) scan. A
history of prior radiation pneumonitis in the radiation field (fibrosis) is
permitted.
- Unresolved or neuroendocrine histology, nor sarcomatoid features adverse event (AE)
>= Grade 2 from prior anticancer therapy, except for alopecia or anemia.
Participants with hormone deficiencies caused by prior anticancer therapy who are
asymptomatic and on a stable dose of replacement hormone are eligible for study.
- Major surgery within 21 days prior to randomization.
- Clinically significant condition(s) as listed in the protocol.