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RecruitingInterventionalPhase 2/Phase 3

Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan 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

NCT ID: NCT07155187Sponsor: AbbVieLast updated: 2026-03-11

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 assess adverse events and change in disease activity of telisotuzumab adizutecan compared to standard of care (SOC). 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. 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 430 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. 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.

Arms & interventions

  • DrugTelisotuzumab Adizutecan

    Intravenous (IV) Infusion

  • DrugStandard of Care

    Standard of Care

Outcome measures

Primary

  • Phase 2: Objective Response (OR) Assessed by Blinded Independent Central Review (BICR)

    OR is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) per BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Time frame: Up to Approximately 69 Months

  • Phase 3: Progression-Free Survival (PFS) as assessed by BICR

    PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by BICR or death from any cause, whichever occurs earlier.

    Time frame: Up to Approximately 69 Months

Secondary

  • Phase 2 and 3: Overall Survival (OS) as assessed by BICR

    Time frame: Up to Approximately 69 Months

  • Phase 2: PFS as assessed by BICR

    Time frame: Up to Approximately 69 Months

  • Phase 2 and 3: Duration of Response (DoR) as Assessed by the BICR per RECIST v1.1

    Time frame: Up to Approximately 69 Months

  • Phase 2 and 3: Disease Control (DC) as Assessed by the BICR per RECIST v1.1

    Time frame: Up to Approximately 69 Months

  • Phase 3: OR Assessed by BICR

    Time frame: Up to Approximately 69 Months

  • Phase 3: Percentage of Participants with Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)

    Time frame: Up to Week 12

  • Phase 3: Percentage of Participants with 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 QLQLC13)

    Time frame: Up to Week 12

  • Phase 3: Percentage of Participants with Change from Baseline in GHS/QoL as measured by the EORTC QLQ-C30

    Time frame: Up to Week 12

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * 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 archived or recently obtained tumor tissue during Screening. * 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. * 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. * Central nervous system (CNS) metastasis, these should be clinically asymptomatic or stable after definitive treatment. * Current, historical, or suspected interstitial lung disease (ILD)/pneumonitis that required steroids should be excluded. * If the prior third-generation EGFR TKI was administered in the adjuvant setting, progression must have occurred while on treatment. Exclusion Criteria: * Tumor(s) have adenosquamous or squamous histology or sarcomatoid features. * Received more than 1 line of systemic therapy in the locally advanced or metastatic setting. * Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.

Study locations (8)

Highlands Oncology Group - Springdale /ID# 277132

Springdale, Arkansas, 72762

Recruiting
Site Coordinator · Contact

Cancer Care Centers of Brevard- Rockledge /ID# 277853

Rockledge, Florida, 32955

Recruiting

HealthPartners Cancer Research Center /ID# 277339

Saint Louis Park, Minnesota, 55426

Recruiting

Nho - Revive Research Institute /ID# 277569

Lincoln, Nebraska, 68506

Recruiting

Astera Cancer Care /ID# 277570

East Brunswick, New Jersey, 08816-4096

Recruiting

Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891

Knoxville, Tennessee, 37909

Recruiting

SCRI Oncology Partners /ID# 276959

Nashville, Tennessee, 37203

Recruiting

Northwest Cancer Specialists - Vancouver /ID# 277855

Vancouver, Washington, 98684

Recruiting
A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer | Cancerify