OncoMatch/Clinical Trials/NCT07155187
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
Is NCT07155187 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Telisotuzumab Adizutecan and Standard of Care for non-small cell lung cancer.
Treatment: Telisotuzumab Adizutecan · Standard of Care — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 19 deletion
Required: EGFR l858r
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: third-generation EGFR tyrosine kinase inhibitor — adjuvant, locally advanced, or metastatic
Received one prior third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy ... and experienced documented radiographic disease progression on or after therapy for the most recent regimen administered prior to study entry
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Highlands Oncology Group - Springdale /ID# 277132 · Springdale, Arkansas
- Cancer Care Centers of Brevard- Rockledge /ID# 277853 · Rockledge, Florida
- HealthPartners Cancer Research Center /ID# 277339 · Saint Louis Park, Minnesota
- Nho - Revive Research Institute /ID# 277569 · Lincoln, Nebraska
- Astera Cancer Care /ID# 277570 · East Brunswick, New Jersey
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