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Taking people in TaiwanPhase 2/3

Tests telisotuzumab adizutecan in lung cancer with EGFR mutation after prior treatment

Tests telisotuzumab adizutecan, alone or with osimertinib, in adults with EGFR-mutated lung cancer.

Key facts

Who runs it
AbbVie
Where
Changhua, Kaohsiung City, Taichung, Taipei, and Taoyuan City, TaiwanSee the 8 sitesAlso in 19 other countries, 116 sites
Registry title
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
Status
Recruiting
Phase
Phase 2/3
People taking part
490 people, planned
Started
10 Dec 2025
Expected to end
Sept 2030
Type of study
Interventional, 6 groups
Treatments tested
  • Telisotuzumab Adizutecan
  • Standard of Care
  • Osimertinib
Record updated
5 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with non-squamous non-small cell lung cancer that has an EGFR mutation and has grown after one earlier targeted pill treatment.

Age
18 years or older
Sex
All sexes can join
Disease stage
Locally advanced or metastatic non-squamous non-small cell lung cancer. At least 1 measurable tumor that has not been treated with radiation. ECOG performance status of 0 to 1.
Earlier treatment
Must have had one third-generation EGFR TKI treatment, and the cancer must have grown on or after it. Cannot have had more than 1 line of systemic therapy for advanced or metastatic disease.
Biomarker or test result
EGFR Exon 19 deletion or Exon21 L858R mutation. A tumor tissue sample is needed for c-Met testing.

Main reasons for not taking part

  • Adenosquamous, squamous or sarcomatoid tumor type
  • More than 1 line of systemic therapy for advanced or metastatic disease
  • Active or symptomatic brain or spinal cord (CNS) metastases
  • Active interstitial lung disease or pneumonitis, or a history of it that needed steroids
  • Any medical condition that the investigator thinks would interfere with taking part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Tumor(s) have adenosquamous or squamous histology or sarcomatoid features

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Which best describes your lung cancer?
  • Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
  • Can you look after yourself and are you up and about most of the day?
  • Has your cancer spread to the brain?
  • Has your cancer spread to the lining around the brain or spinal cord?

Where in Taiwan

Also in 19 other countries, 116 sites

  • Changhua Christian Hospital /ID# 277145Changhua, TaiwanTaking people
  • Kaohsiung Chang Gung Memorial Hospital /ID# 277472Kaohsiung City, TaiwanTaking people
  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277138Kaohsiung City, TaiwanTaking people
  • Taichung Veterans General Hospital /ID# 277142Taichung, TaiwanTaking people
  • Mackay Memorial Hospital /ID# 277146Taipei, TaiwanTaking people
  • National Taiwan University Cancer Center (Ntucc) /ID# 277134Taipei, TaiwanTaking people
  • Taipei Veterans General Hospital /ID# 277141Taipei, TaiwanTaking people
  • Linkou Chang Gung Memorial Hospital /ID# 277135Taoyuan City, TaiwanTaking people

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

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.

The 6 groups in the trial

  • Phase 2: Telisotuzumab Adizutecan Dose ATreatment being tested

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

    Treatment: Telisotuzumab Adizutecan

  • Phase 2: Telisotuzumab Adizutecan Dose BTreatment being tested

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

    Treatment: Telisotuzumab Adizutecan

  • Phase 2: Telisotuzumab Adizutecan Dose A + OsimertinibTreatment being tested

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

    Treatment: Telisotuzumab Adizutecan and Osimertinib

  • Phase 2: Telisotuzumab Adizutecan Dose B + OsimertinibTreatment being tested

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

    Treatment: Telisotuzumab Adizutecan and Osimertinib

  • Phase 3: Telisotuzumab Adizutecan Recommended Phase 3 DoseTreatment being tested

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

    Treatment: Telisotuzumab Adizutecan

  • Phase 3: Stand of Care (SOC)Treatment being tested

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

    Treatment: Standard of Care

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Subjects With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI - AndroMETa-Lung-713
Plain-language title
Tests telisotuzumab adizutecan in lung cancer with EGFR mutation after prior treatmentGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07155187, who can take part
Record updated
5 October 2026