Comparing Telisotuzumab Vedotin and Docetaxel for Non-Small Cell Lung Cancer
Official title: A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
Run by AbbVie · NCT04928846 · Data updated 2026-11-12
This study is testing whether a new drug called telisotuzumab vedotin is better than the standard treatment docetaxel for adults with a specific type of lung cancer that has already been treated.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 768 (estimated) |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | telisotuzumab, chemotherapy, radiation, prednisone |
| Locations | 317 sites (Birmingham, Alabama and 316 other locations) |
| Status | Recruiting |
| Started | March 25, 2022 |
| Main results expected | December 2028 |
| Study ends | February 2029 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT04928846 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with previously treated non-squamous NSCLC who have c-Met overexpression.
✕Probably not a fit
Patients with squamous cell lung cancer or those without c-Met overexpression may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness and safety of telisotuzumab vedotin compared to docetaxel in adults with previously treated non-squamous non-small cell lung cancer (NSCLC) that overexpresses c-Met. Participants will be randomly assigned to receive either intravenous telisotuzumab vedotin every two weeks or intravenous docetaxel every three weeks. The study aims to assess changes in disease activity and monitor adverse events associated with each treatment. Approximately 698 participants will be enrolled across 300 sites worldwide.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with c-Met overexpressing NSCLC.
How similar studies have gone: Other studies have shown promising results with targeted therapies in NSCLC, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Projected life expectancy of at least 12 weeks.
* Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay.
* Archival or fresh tumor material must be submitted for assessment of c-Met protein expression levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed.
* If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China).
* A histologically or cytologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
* A known epidermal growth factor receptor (EGFR) activating mutation status.
\-- Participants with EGFR activating mutations are not eligible
* Actionable alterations in genes other than EGFR are eligible.
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
* Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.
* Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC
* Participants WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
* Participants WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase \[ALK\] translocation): must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy.
* Participants with gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
* Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
* Participants with metastases to the central nervous system (CNS) are eligible only after adequate treatment (such as surgery, radiotherapy, or drug therapy) is provided and:
* They are asymptomatic and off or on a stable or reducing dose of systemic steroids (on no more than 10 mg per day \[QD\] prednisone or equivalent) and/or anticonvulsants for at least 2 weeks prior to randomization.
Exclusion Criteria:
* Evidence of new, untreated CNS metastases or progressing CNS metastases after treatment.
* Evidence of leptomeningeal disease.
* Participants with adenosquamous or neuroendocrine histology, nor sarcomatoid features.
* Epidermal growth factor receptor (EGFR) activating mutations.
* Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E..
* Participants who have received prior docetaxel therapy.
* A history of other malignancies except:
* Malignancy treated with curative intent and with no known active disease present for \>=2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator. Additionally, participants must not be receiving any ongoing anti-cancer therapy, including maintenance therapy, prior to randomization..
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
* Adequately treated carcinoma in situ without current evidence of disease.
* A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, evidence of active pneumonitis on screening chest computed tomography (CT) scan or prior pneumonectomy. A history of prior radiation pneumonitis in the radiation field (fibrosis) is not permitted.
* Unresolved nor adverse event (AE) \>= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study.
* Major surgery within 21 days prior to randomization.
* Clinically significant condition(s) as listed in the protocol.
Where it's running
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City of Hope /ID# 243157
Duarte, California, United States Recruiting -
City Of Hope - Seacliff /ID# 263143
Huntington Beach, California, United States Recruiting -
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 263144
Irvine, California, United States Recruiting -
City Of Hope - Antelope Valley /ID# 263138
Lancaster, California, United States Recruiting -
Kaiser Permanente Moanalua Medical Center /ID# 238363
Honolulu, Hawaii, United States Recruiting -
Hattiesburg Clinic /ID# 248033
Hattiesburg, Mississippi, United States Recruiting
Show 44 more locations
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St. Lukes Hosp. of Kansas City /ID# 259940
Kansas City, Missouri, United States Recruiting -
Hulston Cancer Center /ID# 232226
Springfield, Missouri, United States Recruiting -
Valley Medical Center /ID# 253950
Renton, Washington, United States Recruiting -
Cemic /Id# 231486
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina Recruiting -
Hospital Britanico de Buenos Aires /ID# 231495
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina Recruiting -
Centro Médico Austral /ID# 239860
Ciudad Autonoma Buenos Aires, Buenos Aires F.D., Argentina Recruiting -
Centro de Investigaciones Clinicas Clinica Viedma S.A. /ID# 232339
Viedma, Río Negro Province, Argentina Recruiting -
LC Investigacion /ID# 239880
Buenos Aires, Argentina Recruiting -
Instituto de Oncologia Angel H Roffo /ID# 231499
Buenos Aires, Argentina Recruiting -
Port Macquarie Base Hospital /ID# 273654
Port Macquarie, New South Wales, Australia Recruiting -
Westmead Hospital /ID# 274447
Westmead, New South Wales, Australia Recruiting -
Barwon Health /ID# 241920
Geelong, Victoria, Australia Recruiting -
Austin Health /ID# 247507
Heidelberg, Victoria, Australia Recruiting -
Medizinische Universitaet Wien /ID# 230615
Vienna, State of Vienna, Austria Recruiting -
Klinik Penzing /ID# 230700
Vienna, State of Vienna, Austria Recruiting -
Klinik Floridsdorf /ID# 230608
Vienna, State of Vienna, Austria Recruiting -
Medizinische Universitaet Innsbruck /ID# 240981
Innsbruck, Tyrol, Austria Recruiting -
Ordensklinikum Linz Elisabethinen /ID# 240967
Linz, Upper Austria, Austria Recruiting -
Klinikum Wels-Grieskirchen Gmbh /ID# 249000
Wels, Upper Austria, Austria Recruiting -
Landeskrankenhaus Feldkirch /ID# 250333
Feldkirch, Vorarlberg, Austria Recruiting -
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 232467
Salzburg, Austria Recruiting -
Algemeen Ziekenhuis klina /ID# 239853
Brasschaat, Antwerpen, Belgium Recruiting -
Universitair Ziekenhuis Antwerpen /ID# 239971
Edegem, Antwerpen, Belgium Recruiting -
Grand Hopital de Charleroi - Les Viviers /ID# 234178
Charleroi, Hainaut, Belgium Recruiting -
Hospital La Louviere Site Jolimont - Helora /ID# 246771
La Louvière, Hainaut, Belgium Recruiting -
Jessa Ziekenhuis /ID# 246766
Hasselt, Limburg, Belgium Recruiting -
UZ Gent /ID# 273244
Ghent, Oost-Vlaanderen, Belgium Recruiting -
Vitaz /Id# 246773
Sint-Niklaas, Oost-Vlaanderen, Belgium Recruiting -
Institut Jules Bordet /ID# 246770
Anderlecht, Belgium Recruiting -
AZ Maria Middelares /ID# 246768
Ghent, Belgium Recruiting -
CHU de Liege /ID# 246772
Liège, Belgium Recruiting -
UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 246769
Namur, Belgium Recruiting -
Clinica Amo - Rio Vermelho /ID# 231604
Salvador, Estado de Bahia, Brazil Recruiting -
Hospital Da Crianca Santo Antonio /ID# 233249
Porto Alegre, Rio Grande do Sul, Brazil Recruiting -
Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 233247
Barretos, São Paulo, Brazil Recruiting -
OC Oncoclínicas SP /ID# 261828
São Paulo, São Paulo, Brazil Recruiting -
Instituto Nacional de Cancer (INCA) /ID# 231509
Rio de Janeiro, Brazil Recruiting -
Instituto Dor de Pesquisa e Ensino /ID# 233245
Rio de Janeiro, Brazil Recruiting -
Instituto de Ensino e Pesquisas Sao Lucas /ID# 247417
São Paulo, Brazil Recruiting -
Hospital Sirio Libanes - Sao Paulo /ID# 261827
São Paulo, Brazil Recruiting -
Casa de Saúde Santa Marcelina /ID# 231605
São Paulo, Brazil Recruiting -
Uni Hospital /ID# 273707
Panagyurishte, Pazardzhik, Bulgaria Recruiting -
University Multiprofile Hospital for Active Treatment Sofiamed /ID# 234108
Sofiya, Sofia, Bulgaria Recruiting -
Complex Cancer Center Plovdiv /ID# 234106
Plovdiv, Bulgaria Recruiting
+267 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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IV telisotuzumab adizutecan versus standard treatment for adults with advanced EGFR‑mutated non‑squamous NSCLC
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Assessing the safety of telisotuzumab vedotin in adults with non-small cell lung cancer
This study is testing a new drug called telisotuzumab vedotin to see if it is safe for adults with non-small cell lung cancer that has already been treated.
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Telisotuzumab adizutecan plus osimertinib for first-line treatment of advanced EGFR-mutated non-squamous NSCLC
This test adds the investigational drug telisotuzumab adizutecan to osimertinib (or to osimertinib plus chemotherapy) to see if it helps adults with newly diagnosed advanced EGFR-mutated non-squamous non-small cell lung cancer and to check side effects.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.