Non-Small Cell Lung Cancer
Conditions
Keywords
Non-Small Cell Lung Cancer, Telisotuzumab Adizutecan, ABBV-400, Osimertinib, Standard of Care, Cancer, AndroMETa-Lung-713
Brief summary
Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan as a monotherapy or in combination with osimertinib compared to standard of care (SOC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This study will be divided into two stages, in the first stage (phase 2) participants will receive 1 of 2 doses of telisotuzumab adizutecan as a monotherapy or in combination with osimertinib. In the second stage (phase 3) participants will receive the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan, from the previous stage, or SOC. Approximately 490 adult participants with NSCLC will be enrolled in the study in 200 sites around the world. In phase 2, participants will receive 1 of 2 intravenous (IV) doses of telisotuzumab adizutecan as a monotherapy or in combination with oral osimertinib. In phase 3, participants will receive the IV RP3D of telisotuzumab adizutecan, or SOC. The study will run for a duration of approximately 69 months. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Interventions
DRUGTelisotuzumab Adizutecan
Intravenous (IV) Infusion
DRUGStandard of Care
Standard of Care
DRUGOsimertinib
Oral
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation. * Provide recently obtained tumor tissue during Screening for c-Met immunohistochemistry (IHC) testing (and study stratification in Phase 2). If recently obtained tumor tissue is not available, archived tumor tissue is also acceptable. * Received one prior third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the adjuvant, locally advanced, or metastatic setting, either as monotherapy or in combination with other agents, and experienced documented radiographic disease progression on or after therapy for the most recent regimen administered prior to study entry. Participant who has received prior third-generation EGFR TKI therapy in the adjuvant setting must have progressed while on treatment. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. * At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated.
Exclusion criteria
* Tumor(s) have adenosquamous or squamous histology or sarcomatoid features. * Received more than 1 line of systemic therapy in the locally advanced or metastatic setting. * Active/symptomatic central nervous system (CNS) metastases. Previously treated brain metastases may be included provided they are radiologically stable. * Evidence of active interstitial lung disease (ILD)/pneumonitis or history of ILD or pneumonitis that required steroids. * Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2: Objective Response (OR) Assessed by the Blinded Independent Central Review (BICR) | Up to Approximately 69 Months | OR is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) per the BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. |
| Phase 3: Progression-Free Survival (PFS) as assessed by the BICR | Up to Approximately 69 Months | PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the BICR or death from any cause, whichever occurs earlier. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2 and 3: Overall Survival (OS) | Up to Approximately 69 Months | OS is defined as the time from randomization to the event of death from any cause. |
| Phase 2: PFS as assessed by the BICR | Up to Approximately 69 Months | PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the BICR or death from any cause, whichever occurs earlier. |
| Phase 2 and 3: Duration of Response (DoR) as Assessed by the BICR per RECIST v1.1 | Up to Approximately 69 Months | DoR is defined as the time from the first response (CR or PR) to Progressive Disease (PD) or death (whichever occurs first) amongst confirmed responders. |
| Phase 2 and 3: Disease Control (DC) as Assessed by the BICR per RECIST v1.1 | Up to Approximately 69 Months | DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, version 1.1. |
| Phase 3: OR Assessed by the BICR | Up to Approximately 69 Months | OR is defined as participants achieving a best overall response of confirmed CR or confirmed PR per the BICR based on RECIST version 1.1. |
| Phase 3: Percentage of Participants with Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) | Up to Week 12 | Health-related quality-of-life and symptoms will be assessed with the EORTC QLQ-C30, version 3.0. The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status (GHS)/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4 point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much). |
| Phase 3: Percentage of Participants with Change from Baseline in Key Lung Cancer Symptoms as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQLC13) | Up to Week 12 | The EORTC QLQ-LC13 is a lung cancer specific module and consists of 13 questions assessing lung cancer-associated symptoms and treatment-related effects, including one multiple-item scale to assess dyspnea and a series of single items assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain, and pain medication. Each item is assessed on a Likert scale from 1 (not at all) to 4 (very much). |
| Phase 3: Percentage of Participants with Change from Baseline in GHS/QoL as measured by the EORTC QLQ-C30 | Up to Week 12 | Health-related quality-of-life and symptoms will be assessed with the EORTC QLQ-C30, version 3.0. The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a GHS/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4 point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much). |
Countries
Australia, Austria, Belgium, Canada, China, France, Germany, Israel, Italy, Japan, Netherlands, Poland, Portugal, Serbia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed