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

NCT07821684 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: M26-1672025-524802-13-002025
• Study Type: interventional
• Target: 660
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; NSCLC; Non-Squamous NSCLC; Telisotuzumab Adizutecan; ABBV-400; Cancer

Outcome Measures

Primary Outcomes (2)

• Objective Response (OR) Based on Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  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)

  OS is defined as the time from date of randomization to the event of death from any cause.

  Up to Approximately 50 Months

Secondary Outcomes (6)

• Progression-Free Survival (PFS) Based on BICR Assessment Per RECIST Version 1.1

  Up to Approximately 24 Months

• Duration of Response (DoR) Based on BICR Assessment Per RECIST Version 1.1

  Up to Approximately 24 Months

• Disease Control (DC) Based on BICR Assessment Per RECIST Version 1.1

  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)

  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)

  Up to Week 12

Study Arms (2)

Telisotuzumab Adizutecan

EXPERIMENTAL

Participants will receive telisotuzumab adizutecan until meeting study drug discontinuation criteria.

Drug: Telisotuzumab Adizutecan

Standard of care (SOC)

ACTIVE COMPARATOR

Participants will receive SOC docetaxel or docetaxel plus ramucirumab until meeting study drug discontinuation criteria.

Drug: Docetaxel; Drug: Ramucirumab

Interventions

Telisotuzumab Adizutecan DRUG

Intravenous (IV)

Telisotuzumab Adizutecan

Docetaxel DRUG

IV

Standard of care (SOC)

Ramucirumab DRUG

IV

Standard of care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

Docetaxel; Ramucirumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start (Estimated): January 6, 2027
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/