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Clinical Trials List

Protocol NumberM25-713

NCT Number(ClinicalTrials.gov Identfier)NCT07155187

Active

2025-10-01 - 2032-01-31

Phase II/III

Recruiting8

ICD-10C33

Malignant neoplasm of trachea

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.0

Malignant neoplasm of trachea

A phase 2/3, open-label, randomized trial evaluating the efficacy of telisotuzumab adizutecan monotherapy versus osimertinib in patients with locally advanced or metastatic EGFR-mutated non-squamous non-small cell lung cancer who have progressed after third-generation EGFR TKI therapy, compared with standard of care. - AndroMETa-Lung-713

Trial Applicant

AbbVie
Sponsor

AbbVie Pharmaceuticals Ltd. Taiwan Branch
Trial scale

Multi-Regional Multi-Center
Update

2026/07/07

Investigators and Locations

Principal Investigator CHIN-CHOU WANG 無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Hung Luo 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Yu Hung 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林聖皓無

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator James Chih-Hsin Yang 無

National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蘇健無

MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Ta Yang

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Subjects with locally advanced or metastatic non-squamous non-small cell lung cancer that has progressed after third-generation EGFR TKI treatment

Objectives

The aim of this clinical trial is to select the optimal dose and evaluate the safety and efficacy of Telisotuzumab Adizutecan (ABBV-400, Temb-A) monotherapy or in combination with Osimertinib and standard therapy as a potential treatment option for patients with EGFR mutations who have progressed on previous EGFR-targeted therapy.

Test Drug

Telisotuzumab Adizutecan (ABBV-400)

Active Ingredient

Telisotuzumab Adizutecan (ABBV-400)

Dosage Form

N/A

Dosage

N/A

Endpoints

Phase 2:

• Evaluate the safety and tolerability of telisotuzumab adizutecan monotherapy or in combination with osimertinib.

• Evaluate the efficacy of telisotuzumab adizutecan monotherapy or in combination with osimertinib based on the overall response rate (OR) assessed by a blinded independent central review committee (BICR).

• Select the Phase 3 recommended dose (RP3D) for telisotuzumab adizutecan monotherapy or in combination with osimertinib.

Phase 3:

• Evaluate the efficacy of telisotuzumab adizutecan compared to standard care based on progression-free survival (PFS) assessed by BICR.

Inclution Criteria

• Participants must be at least 18 years old (or the age permitted by local regulations, whichever is older).

• Participants must have a histological or cytological diagnosis of locally advanced or metastatic non-squamous NSCLC, and have data showing EGFR exon 19 deletion or exon 21 L858R mutation detected in a Clinical Laboratory Improvement Amendment (CLIA) certified laboratory (trial center in the United States) or an accredited local laboratory (trial center outside the United States), under standard trial center care, using FDA-approved or other validated testing methods.

• Participants must provide recently obtained tumor tissue at screening for c-Met immunohistochemistry (IHC) testing (and for Phase 2 trial stratification). If recently obtained tumor tissue is unavailable, retained tumor tissue is acceptable.

Subjects must have previously received a third-generation EGFR TKI therapy, either as monotherapy or in combination with other drugs, in adjuvant, locally advanced, or metastatic settings, and data must show radiographic disease progression during or after the most recent treatment session prior to enrollment in the trial. Subjects who previously received a third-generation EGFR TKI in adjuvant settings must have experienced disease progression during treatment.

Subjects' East Coast Cancer Clinical Research Consortium (ECOG) performance status must be 0 to 1.

Subjects must have at least one previously untreated lesion measurable according to RECIST version 1.1.

If subjects have central nervous system (CNS) metastases, these should be clinically asymptomatic or stable after curative treatment.
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Exclusion Criteria

• Subjects must not have received more than one line of locally advanced or metastatic systemic therapy.

• Subjects who currently have, have had, or are suspected of having interstitial lung disease (ILD)/pneumonia and require steroids should be excluded.

• Subjects must not have any clinically significant medical condition, or any other reason that the trial administrator deems would interfere with subject participation.

The Estimated Number of Participants

Taiwan

40 participants
Global

430 participants