Description:
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.
Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group
receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel.
Approximately 600 adult participants with c-Met+ NSCLC will be enrolled in the study in
approximately 250 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.
Title
- Brief Title: A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
- Official Title: A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met+, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
Clinical Trial IDs
- ORG STUDY ID:
M18-868
- SECONDARY ID:
2021-001811-94
- NCT ID:
NCT04928846
Conditions
- Non Small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
Telisotuzumab Vedotin | ABBV-399 | Telisotuzumab Vedotin |
Docetaxel | | Docetaxel |
Purpose
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.
Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group
receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel.
Approximately 600 adult participants with c-Met+ NSCLC will be enrolled in the study in
approximately 250 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.
Trial Arms
Name | Type | Description | Interventions |
---|
Telisotuzumab Vedotin | Experimental | Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria. | |
Docetaxel | Active Comparator | Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria. | |
Eligibility Criteria
Inclusion Criteria:
- Participants must have c-Met overexpression (c-Met+) non-small cell lung cancer
(NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory.
- Archival or fresh tumor material must be submitted for assessment of c-Met levels
during the Pre-Screening period.
- A histologically 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 WITH an actionable gene alteration (e.g., anaplastic lymphoma kinase
[ALK] translocation): must have progressed on (or be considered ineligible for)
anti-cancer therapy targeting driver gene alterations and systemic cytotoxic
chemotherapy.
- Participants WITHOUT an actionable gene alteration: must have progressed on (or
be considered ineligible for) systemic cytotoxic chemotherapy and immune
checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
- Participants 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.
Exclusion Criteria:
- Participants with adenosquamous histology.
- Actionable epidermal growth factor receptor (EGFR) activating mutations.
- Participants who have received prior c-Met-targeted antibodies.
- 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 clinically significant adverse event (AE) >= Grade 2 from prior anticancer
therapy, except for alopecia or anemia.
- Major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
- Clinically significant condition(s) as listed in the protocol.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-Free Survival (PFS) |
Time Frame: | Up to approximately 39 months |
Safety Issue: | |
Description: | PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) per Independent Central Review (ICR) or death from any cause. |
Secondary Outcome Measures
Measure: | Overall Survival (OS) |
Time Frame: | Up to approximately 58.25 months |
Safety Issue: | |
Description: | OS is defined as the time from randomization to the event of death from any cause. |
Measure: | Objective Response Rate (ORR) |
Time Frame: | Up to approximately 58.25 months |
Safety Issue: | |
Description: | ORR is defined as the percentage of subjects with a complete response (CR) or partial response (PR) based on RECIST v1.1, per ICR. |
Measure: | Duration of Response (DoR) |
Time Frame: | Up to approximately 58.25 months |
Safety Issue: | |
Description: | DoR is defined for responders as the time from response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause per ICR. |
Measure: | Time to Deterioration in Cough, Pain or Dyspnea as measured by the Cough, Pain and Dyspnea items of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) |
Time Frame: | Up to approximately 58.25 months |
Safety Issue: | |
Description: | The EORTC QLQ-LC13 is the lung cancer specific module of the core EORTC QLQ-C30. The QLQ-LC13 includes 13 questions that include both multi-item and single-item scales of lung cancer-associated symptoms (e.g., pain, coughing, hemoptysis, and dyspnea) and side-effects from chemo- and radiotherapy (e.g., hair loss, neuropathy, sore mouth and dysphagia). All scale and item scores are linearly transformed to a 0 to 100 scale, with higher scores representing increasing symptom levels or impacts. |
Measure: | Time to Deterioration of Physical Functioning as measured by the Physical Functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30). |
Time Frame: | Up to approximately 58.25 months |
Safety Issue: | |
Description: | The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden. |
Measure: | Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30. |
Time Frame: | Up to approximately 58.25 months |
Safety Issue: | |
Description: | The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden. |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | AbbVie |
Trial Keywords
- c-Met Overexpression Non-Small Cell Lung Cancer
- c-Met+ NSCLC
- Telisotuzumab Vedotin
- ABBV-399
- Docetaxel
- Cancer
- Non Small Cell Lung Cancer
- NSCLC
Last Updated
June 16, 2021