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

Official record

Identifier

NCT07155187

Recruiting locations

countries

United StatesAustraliaAustriaBelgiumCanadaChinaFranceGermanyIsraelItalyJapanNetherlandsPolandPortugalSerbiaSouth KoreaSpainTaiwanTurkey (Türkiye)United Kingdom

Interventions studied

Telisotuzumab AdizutecanStandard of CareOsimertinib

Lead sponsor

AbbVie

Target enrolment

490 participants

Study type

INTERVENTIONAL

Phase

Phase 2/3

Status

Recruiting

First posted

Sep 4, 2025

Last updated on the registry

Oct 1, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* 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 recently obtained tumor tissue during Screening for c-Met immunohistochemistry (IHC) testing (and study stratification in Phase 2). If recently obtained tumor tissue is not available, archived tumor tissue is also acceptable.
* 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.
* 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.

Exclusion Criteria:

* 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.
* Active/symptomatic central nervous system (CNS) metastases. Previously treated brain metastases may be included provided they are radiologically stable.
* Evidence of active interstitial lung disease (ILD)/pneumonitis or history of ILD or pneumonitis that required steroids.
* Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.

Indexed under

Lung Cancer