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A Study to Assess Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants Previously Treated, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

10 september 2026 uppdaterad av: AbbVie

A Phase 3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects With Previously Treated, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer Expressing c-Met Protein Level Above a Defined Cutoff

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 evaluate whether telisotuzumab adizutecan improves response rate and overall survival compared to standard of care in participants with epidermal growth factor receptor (EGFR) wildtype non-squamous NSCLC who have high c-Met protein expression and have progressed after standard therapies.

Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This is an open-label study where participants and doctors know which treatment is being administered. Participants are randomized into 2 groups called treatment arms. One group will receive telisotuzumab adizutecan, while the other group will receive standard of care (SOC) treatment consisting of Docetaxel or Docetaxel with Ramucirumab. Around 660 participants will be enrolled in the study at approximately 250 sites worldwide.

Participants will receive either doses of Intravenous (IV) telisotuzumab adizutecan or IV SOC of docetaxel alone or docetaxel with ramucirumab. The study will run for a duration of approximately 50 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

660

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic/locally advanced non-squamous NSCLC
  • Known EGFR activating mutation status (EGFR wildtype only; participants with EGFR activating mutations are not eligible)
  • Cellular-mesenchymal epithelial transition (c-Met) Immunohistochemistry (IHC) staining as assessed by AbbVie designated IHC Laboratory
  • 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:

  • Participant tumor(s) has (have) mixed adenosquamous or squamous or neuroendocrine histology or sarcomatoid features
  • Known active/symptomatic brain metastases
  • History of interstitial lung disease (ILD) or pneumonitis that required systemic steroids
  • Major, life-threatening medical conditions with life expectancy less than 3 months
  • Clinically significant medical conditions or other reasons that would interfere with study participation

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Telisotuzumab Adizutecan
Participants will receive telisotuzumab adizutecan until meeting study drug discontinuation criteria.
Läkemedel: Telisotuzumab Adizutecan
Intravenöst (IV)
Aktiv komparator: Standard of care (SOC)
Participants will receive SOC docetaxel or docetaxel plus ramucirumab until meeting study drug discontinuation criteria.
Läkemedel: Docetaxel
IV
Läkemedel: Ramucirumab
IV

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Objective Response (OR) Based on Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Tidsram: Up to Approximately 24 Months
OR is defined as participants achieving a best overall response of confirmed complete response (CR) or partial response (PR) per BICR based on RECIST version 1.1.
Up to Approximately 24 Months
Overall Survival (OS)
Tidsram: Up to Approximately 50 Months
OS is defined as the time from date of randomization to the event of death from any cause.
Up to Approximately 50 Months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression-Free Survival (PFS) Based on BICR Assessment Per RECIST Version 1.1
Tidsram: Up to Approximately 24 Months
PFS is defined as the time from date of randomization to the first occurrence of radiographic progression based on RECIST v1.1 or death from any cause, whichever occurs earlier.
Up to Approximately 24 Months
Duration of Response (DoR) Based on BICR Assessment Per RECIST Version 1.1
Tidsram: Up to Approximately 24 Months
DoR defined as time from the date of initial response of confirmed CR or PR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first. DoR is defined for subjects with confirmed CR/PR.
Up to Approximately 24 Months
Disease Control (DC) Based on BICR Assessment Per RECIST Version 1.1
Tidsram: Up to Approximately 24 Months
DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, v1.1
Up to Approximately 24 Months
Change From Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Tidsram: Up to Week 12
The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Participants rate items on a 4-point scale ranging from 1 (not at all) to 4 (very much).
Up to Week 12
Change From Baseline in Key Lung Cancer Symptoms as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Tidsram: Up to Week 12
The EORTC QLQ-LC13 is a lung cancer specific module and consists of 13 questions assessing lung cancer-associated symptoms and treatment-related effects, including one multiple-item scale to assess dyspnea and a series of single items assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain, and pain medication. Each item is assessed on a Likert scale from 1 (not at all) to 4 (very much).
Up to Week 12
Change From Baseline in Global Health Status/Quality of Life (GHS/QoL) as Measured by the EORTC QLQ-C30
Tidsram: Up to Week 12
Health-related quality-of-life and symptoms will be assessed with the EORTC QLQ-C30. The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a GHS/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4 point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much).
Up to Week 12

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AbbVie

Utredare

  • Studierektor: ABBVIE INC., AbbVie

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

6 januari 2027

Primärt slutförande (Beräknad)

1 april 2031

Avslutad studie (Beräknad)

1 april 2031

Studieregistreringsdatum

Först inskickad

10 september 2026

Först inskickad som uppfyllde QC-kriterierna

10 september 2026

Första postat (Faktisk)

16 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • M26-167
  • 2025 (U.S.S. NIH-anslag/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-524802-13-00 (Annan identifierare: EU CT)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

Kriterier för IPD Sharing Access

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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