OncoMatch/Clinical Trials/NCT07155187
A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, 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 (Sep 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 · Osimertinib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 19 deletion
documented EGFR Exon 19 deletion or Exon21 L858R mutation
Required: EGFR l858r
documented EGFR Exon 19 deletion or Exon21 L858R mutation
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 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Highlands Oncology Group - Springdale /ID# 277132 · Springdale, Arkansas
- City of Hope National Medical Center /ID# 277005 · Duarte, California
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277928 · Irvine, California
- Cancer Specialists of North Florida /ID# 277332 · Jacksonville, Florida
- Cancer Care Centers of Brevard- Rockledge /ID# 277853 · Rockledge, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07155187 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received third-generation EGFR tyrosine kinase inhibitor.
Does this trial require EGFR?
Yes, EGFR exon 19 deletion is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR l858r is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify