A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Drug: Standard of Care
- Registration Number
- NCT07155187
- Lead Sponsor
- AbbVie
- 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 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. 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 430 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 430
- 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 archived or recently obtained tumor tissue during Screening.
- 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.
- 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.
- Central nervous system (CNS) metastasis, these should be clinically asymptomatic or stable after definitive treatment.
- Current, historical, or suspected interstitial lung disease (ILD)/pneumonitis that required steroids should be excluded.
- If the prior third-generation EGFR TKI was administered in the adjuvant setting, progression must have occurred while on treatment.
- 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.
- Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 2: Telisotuzumab Adizutecan Dose A Telisotuzumab Adizutecan Participants will receive telisotuzumab adizutecan dose A, as part of the approximately 69 month study duration. Phase 2: Telisotuzumab Adizutecan Dose B Telisotuzumab Adizutecan Participants will receive telisotuzumab adizutecan dose B, as part of the approximately 69 month study duration. Phase 3: Telisotuzumab Adizutecan Recommended Phase 3 Dose Telisotuzumab Adizutecan Participants will receive telisotuzumab adizutecan at the recommended phase 3 dose, as part of the approximately 69 month study duration. Phase 3: Stand of Care (SOC) Standard of Care Participants will receive investigator's choice of SOC, as part of the approximately 69 month study duration.
- Primary Outcome Measures
Name Time Method Phase 2: Objective Response (OR) Assessed by 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 BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Phase 3: Progression-Free Survival (PFS) as assessed by 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 BICR or death from any cause, whichever occurs earlier.
- Secondary Outcome Measures
Name Time Method Phase 2 and 3: Overall Survival (OS) as assessed by BICR 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 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 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 BICR Up to Approximately 69 Months OR is defined as participants achieving a best overall response of confirmed CR or confirmed PR per 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).