Recruiting

Phase 2

Phase 3

Telisotuzumab AdizutecanA 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

Sponsor:

AbbVie

Code:

NCT07155187

Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Telisotuzumab Adizutecan

Standard of Care

Osimertinib

Study Details

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 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.

Conditions

Non-Small Cell Lung Cancer

Study ID

NCT07155187

Start date

Dec 10, 2025

Status verified date

Jul, 2026

Completion date

Sep, 2030

Anticipated

Primary completion date

Sep, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

490 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 2: Telisotuzumab Adizutecan Dose A

Participants will receive telisotuzumab adizutecan dose A, as part of the approximately 69 month study duration.

experimental: Phase 2: Telisotuzumab Adizutecan Dose B

Participants will receive telisotuzumab adizutecan dose B, as part of the approximately 69 month study duration.

experimental: Phase 2: Telisotuzumab Adizutecan Dose A + Osimertinib

Participants will receive telisotuzumab adizutecan dose A in combination with osimertinib, as part of the approximately 69 month study duration.

experimental: Phase 2: Telisotuzumab Adizutecan Dose B + Osimertinib

Participants will receive telisotuzumab adizutecan dose B in combination with osimertinib, as part of the approximately 69 month study duration.

experimental: Phase 3: Telisotuzumab Adizutecan Recommended Phase 3 Dose

Participants will receive telisotuzumab adizutecan at the recommended phase 3 dose, as part of the approximately 69 month study duration.

experimental: Phase 3: Stand of Care (SOC)

Participants will receive investigator's choice of SOC, as part of the approximately 69 month study duration.

Interventions

Telisotuzumab Adizutecan

Intravenous (IV) Infusion

Standard of Care

Osimertinib

Oral

Primary outcome measure

Phase 2: Objective Response (OR) Assessed by the Blinded Independent Central Review (BICR) [ Time Frame: Up to Approximately 69 Months ]
Phase 3: Progression-Free Survival (PFS) as assessed by the BICR [ Time Frame: Up to Approximately 69 Months ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742 abbvieclinicaltrials@abbvie.com

Locations

Highlands Oncology Group - Springdale /ID# 277132

Recruiting

Springdale, Arkansas, United States, 72762

Contacts

Site Coordinator

479-872-8130

City of Hope National Medical Center /ID# 277005

Recruiting

Duarte, California, United States, 91010

City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277928

Recruiting

Irvine, California, United States, 92618

Cancer Specialists of North Florida /ID# 277332

Recruiting

Jacksonville, Florida, United States, 32256

Cancer Care Centers of Brevard- Rockledge /ID# 277853

Recruiting

Rockledge, Florida, United States, 32955

Moffitt Cancer Center /ID# 276785

Recruiting

Tampa, Florida, United States, 33612

Parkview Research Center /ID# 277651

Recruiting

Fort Wayne, Indiana, United States, 46845

HealthPartners Cancer Research Center /ID# 277339

Recruiting

Saint Louis Park, Minnesota, United States, 55426

Nho - Revive Research Institute /ID# 277569

Recruiting

Lincoln, Nebraska, United States, 68506

Dartmouth-Hitchcock Medical Center /ID# 277673

Recruiting

Lebanon, New Hampshire, United States, 03756

Astera Cancer Care /ID# 277570

Recruiting

East Brunswick, New Jersey, United States, 08816-4096

Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891

Recruiting

Knoxville, Tennessee, United States, 37909

SCRI Oncology Partners /ID# 276959

Recruiting

Nashville, Tennessee, United States, 37203

Fred Hutchinson Cancer Center. /ID# 277939

Recruiting

Seattle, Washington, United States, 98109-4405

Northwest Cancer Specialists - Vancouver /ID# 277855

Recruiting

Vancouver, Washington, United States, 98684

More Information

Sponsor

AbbVie

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

Non-Small Cell Lung Cancer
Telisotuzumab Adizutecan
ABBV-400
Osimertinib
Standard of Care
Cancer
AndroMETa-Lung-713

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-07-09.