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Non Small Cell Lung CancerPhase 2NCT05513703

A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 study testing Telisotuzumab Vedotin in people with Non Small Cell Lung Cancer, run by AbbVie at 29 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Telisotuzumab Vedotin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
29 sitesin 9 countries
Study dates
21 Nov 2022to 28 Oct 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must have MET amplification in tumor tissue as determined by the Sponsor-designated central laboratory MET FISH Assay or in plasma and/or tissue by a Sponsor-approved assay.
  • Must have histologically documented non-squamous adenocarcinoma non-small cell lung cancer (NSCLC) that is locally advanced or metastatic.
  • Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Participant may have received prior adjuvant/neoadjuvant systemic chemotherapy and/or radiation and/or immunotherapy provided that the subject has not progressed on or within 6 months of completing the regimen and it was completed >= 6 months before subject's first dose of study drug.
  • Metastases to the central nervous system (CNS) are eligible only after definitive therapy is provided as noted in the protocol.
  • History of radiation pneumonitis in the radiation field (fibrosis) is permitted.

Who cannot join

  • Alterations in EGFR, ALK, ROS1, or BRAF that predict sensitivity to available targeted therapy. Participants with other alterations that are candidates for available targeted therapy.
  • Prior systemic therapy for locally advanced/metastatic NSCLC. Of note, limited treatment with no more than 1 cycle of chemotherapy is allowed prior to receiving the first dose of study drug provided there is no evidence of progression.
  • Have a history of other malignancies except those noted in the protocol.
  • Have a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
  • Received prior c-Met-targeted antibodies.
  • Have NSCLC that is eligible for treatment with curative intent.
Show all 9Show fewer
  • Have unresolved adverse events (AEs) >= Grade 2 from prior anticancer therapy, except for alopecia or anemia.
  • Have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
  • Have clinically significant condition(s) as noted in the protocol.

Trial locations and contacts

29 sites in 9 countries.

29 sites in 9 countries

Japan6 sites

  • National Cancer Center Hospital /ID# 250319

    Chuo-ku, Tokyo, 104-0045

  • Duplicate_National Hospital Organization Kyushu Cancer Center /ID# 250714

    Fukuoka, Fukuoka, 811-1395

  • National Cancer Center Hospital East /ID# 250317

    Kashiwa-shi, Chiba, 277-8577

  • Osaka International Cancer Institute /ID# 251507

    Osaka, Osaka, 541-8567

  • Hokkaido University Hospital /ID# 250316

    Sapporo, Hokkaido, 060-8648

  • Shizuoka Cancer Center /ID# 251752

    Sunto-gun, Shizuoka, 411-8777

Other trials in Japan

Israel5 sites

  • Rambam Health Care Campus /ID# 246781

    Haifa, H_efa, 3109601

  • Hadassah Medical Center-Hebrew University /ID# 243298

    Jerusalem, Jerusalem, 91120

  • Meir Medical Center /ID# 243208

    Kfar Saba, Central District, 4428164

  • Rabin Medical Center /ID# 248631

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center /ID# 243207

    Ramat Gan, Tel Aviv, 5265601

Other trials in Israel

South Korea4 sites

  • Chungbuk National University Hospital /ID# 248405

    Cheongju-si, North Chungcheong, 28644

  • Keimyung University Dongsan Hospital /ID# 247371

    Daegu, Gyeongsangbuk-do, 42601

  • Samsung Medical Center /ID# 248407

    Seoul, Seoul Teugbyeolsi, 06351

  • Pusan National University Yangsan Hospital /ID# 248489

    Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

Taiwan4 sites

  • Kaohsiung Chang Gung Memorial Hospital /ID# 248143

    Kaohsiung City, Kaohsiung, 833

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 248144

    Kaohsiung City, 807

  • National Cheng Kung University Hospital /ID# 248142

    Tainan, 704

  • Linkou Chang Gung Memorial Hospital /ID# 248145

    Taoyuan City, 333

Other trials in Taiwan

France3 sites

  • Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 246267

    Bron, Rhone, 69500

  • Centre Jean Perrin /ID# 246268

    Clermont-Ferrand, 63011

  • CHU Lille - Hôpital Albert Calmette /ID# 246263

    Lille, Hauts-de-France, 59037

Other trials in France

Italy3 sites

  • Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 248329

    Candiolo, Torino, 10060

  • Duplicate_Fondazione IRCCS San Gerardo dei Tintori /ID# 247584

    Monza, Monza E Brianza, 20900

  • IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 247585

    Rome, 00144

Other trials in Italy

United States2 sites

  • Cancer and Blood Speciality Clinic - Los Alamitos /ID# 251671

    Los Alamitos, California, 90720-3309

  • Valley Medical Center /ID# 251880

    Renton, Washington, 98055-5738

Other trials in United States

Australia1 site

  • Monash Health - Monash Medical Centre /ID# 247679

    Clayton, Victoria, 3168

Other trials in Australia

Germany1 site

  • Asklepios Fachkliniken Muenchen-Gauting /ID# 248082

    Gauting, 82131

Other trials in Germany

About this study

Official title: Phase 2, Open-Label Study in Subjects With Previously Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine how telisotuzumab vedotin affects the disease state in adult participants with previously untreated participants with MET amplified non-squamous NSCLC. Change in disease activity will be assessed.

Telisotuzumab vedotin is an investigational drug being developed for the treatment of MET amplified non-squamous NSCLC. Participants receive intravenously (IV) infused of telisotuzumab vedotin. Approximately 70 adult participants with previously untreated MET amplified locally advanced/metastatic non-squamous NSCLC will be enrolled in the study in approximately 110 sites worldwide.

Read more

Participants will receive IV telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.

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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Being tested
Telisotuzumab Vedotin
Keywords
c-Met NSCLC, Telisotuzumab Vedotin, ABBV-399, Cancer, Non Small Cell Lung Cancer, NSCLC, MET Amplified NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telisotuzumab VedotinBiological

    Also called ABBV-399

    Intravenous (IV) Infusion

Study groups in NCT05513703
Study groupRoleWhat they receive
Telisotuzumab VedotinExperimentalParticipants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.
Receives: Biological: Telisotuzumab Vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) as Assessed by an Independent Central Review (ICR)

    ORR was defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 as assessed by ICR.

    Measured: Up to approximately 1.5 years

Secondary outcomes (8)

  1. Duration of Response (DoR)

    DoR was defined for confirmed responders as the time from the initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1, or death from any cause.

    Measured: Up to approximately 1.5 years

  2. Disease Control Rate (DCR)

    DCR was defined as the percentage of participants with best overall response of confirmed CR or confirmed PR, or stable disease (SD) for at least 12 weeks following first dose of study drug, based on RECIST, version 1.1.

    Measured: Up to approximately 1.5 years

  3. Progression Free Survival (PFS) Per ICR

    PFS was defined as the time from the participant's first dose of study drug to the first occurrence of radiographic progression based on RECIST, version 1.1 or death from any cause.

    Measured: Up to approximately 1.5 years

  4. Overall Survival (OS)

    OS was defined as the time from participant's first dose of study drug to the event of death from any cause.

    Measured: Up to approximately 1.5 years

  5. Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)

    The cough item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms.

    Measured: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32

  6. Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13

    The pain in chest item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms.

    Measured: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32

  7. Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13

    The dyspnea item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms.

    Measured: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32

  8. Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).

    The Global Health Status/Quality of Life Domain of the EORTC QLQ-C30 was reported on a scale of 0 to 100, with higher scores indicating better global health status/functioning and a positive change from baseline indicating improvement.

    Measured: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2022
  2. Study start21 Nov 2022
  3. Primary completion28 Oct 2024
  4. Study completion28 Oct 2024

Why it stopped: Strategic considerations

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05513703
Sponsor's protocol ID
M22-137
Other IDs
2022-500608-23-00
Status last verified
Oct 2025
First submitted
23 Aug 2022
Last updated
24 Oct 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telisotuzumab Vedotin in people with Non Small Cell Lung Cancer, run by AbbVie at 29 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Japan, Israel, South Korea, Taiwan, France and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) as Assessed by an Independent Central Review (ICR) (time frame: Up to approximately 1.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05513703.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.

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