Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI
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.
Arms & interventions
- DrugTelisotuzumab Adizutecan
Intravenous (IV) Infusion
- DrugStandard of Care
Standard of Care
Outcome measures
Primary
Phase 2: Objective Response (OR) Assessed by Blinded Independent Central Review (BICR)
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.
Time frame: Up to Approximately 69 Months
Phase 3: Progression-Free Survival (PFS) as assessed by BICR
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.
Time frame: Up to Approximately 69 Months
Secondary
Phase 2 and 3: Overall Survival (OS) as assessed by BICR
Time frame: Up to Approximately 69 Months
Phase 2: PFS as assessed by BICR
Time frame: Up to Approximately 69 Months
Phase 2 and 3: Duration of Response (DoR) as Assessed by the BICR per RECIST v1.1
Time frame: Up to Approximately 69 Months
Phase 2 and 3: Disease Control (DC) as Assessed by the BICR per RECIST v1.1
Time frame: Up to Approximately 69 Months
Phase 3: OR Assessed by BICR
Time frame: Up to Approximately 69 Months
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)
Time frame: Up to Week 12
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)
Time frame: Up to Week 12
Phase 3: Percentage of Participants with Change from Baseline in GHS/QoL as measured by the EORTC QLQ-C30
Time frame: Up to Week 12
Eligibility criteria
Study locations (8)
Highlands Oncology Group - Springdale /ID# 277132
Springdale, Arkansas, 72762
Cancer Care Centers of Brevard- Rockledge /ID# 277853
Rockledge, Florida, 32955
HealthPartners Cancer Research Center /ID# 277339
Saint Louis Park, Minnesota, 55426
Nho - Revive Research Institute /ID# 277569
Lincoln, Nebraska, 68506
Astera Cancer Care /ID# 277570
East Brunswick, New Jersey, 08816-4096
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891
Knoxville, Tennessee, 37909
SCRI Oncology Partners /ID# 276959
Nashville, Tennessee, 37203
Northwest Cancer Specialists - Vancouver /ID# 277855
Vancouver, Washington, 98684