Status:
RECRUITING
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
Lead Sponsor:
AbbVie
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 ac...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT07155187
Start Date
December 10 2025
End Date
September 1 2030
Last Update
January 5 2026
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Highlands Oncology Group - Springdale /ID# 277132
Springdale, Arkansas, United States, 72762
2
Nho - Revive Research Institute /ID# 277569
Lincoln, Nebraska, United States, 68506
3
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891
Knoxville, Tennessee, United States, 37909
4
Northwest Cancer Specialists - Vancouver /ID# 277855
Vancouver, Washington, United States, 98684