A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

NCT07005102 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: M25-2872024-518586-10
• Study Type: interventional
• Target: 854
• Locations: 13 countries
• Sites: 53

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 assess adverse events and change in disease activity "when telisotuzumab adizutecan is given in combination with a fixed dose of osimertinib (Osi)or standard of care (Osi plus platinum/pemetrexed chemotherapy). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. Osi is a drug approved for the treatment of NSCLC. This study will be divided into two stages, in the first stage participants will receive increasing doses of telisotuzumab adizutecan with Osi. Participants will then be randomized into 4 groups called treatment arms where 3 groups will receive 1 of 3 doses of telisotuzumab adizutecan from from the dose escalation phase with Osi, or standard of care (Osi plus chemotherapy). In the second stage participants will receive the optimal dose of telisotuzumab adizutecan, from the previous stage, with Osi, or SOC. Approximately 854 adult participants with 1L estimated glomerular filtration rate (EGFR) mut (mutated) not sufficient quantity (NSq) NSCLC will be enrolled in the study in 200 sites worldwide. In Stage 1, during dose escalation participants will receive increasing intravenous (IV) doses of telisotuzumab adizutecan with oral Osi tablets. participants will receive 1 of 3 doses of telisotuzumab adizutecan with Osi, or standard of care (Osi plus chemotherapy). In stage 2 participants will receive the optimal dose of IV telisotuzumab adizutecanin with oral Osi tablet, or SOC. The study will run for a duration of approximately 76 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-Squamous Non-Small Cell Lung Cancer; Telisotuzumab Adizutecan; Osimertinib; Cisplatin; Carboplatin; Pemetrexed; ABBV-400; Stand of Care; Cancer; Chemotherapy; Platinum Chemotherapy

Outcome Measures

Primary Outcomes (3)

• Stage 1: 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 confirmed complete response (CR) or confirmed partial response (PR) per BICR based on RECIST version 1.1.

  Up to Approximately 76 Months

• Stage 2: Progression-free survival (PFS) based on BICR assessment per RECIST version 1.1.

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

  Up to Approximately 76 Months

• Number of Participants with Adverse Events (AEs)

  An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  Up to Approximately 76 Months

Secondary Outcomes (11)

• Stage 1: PFS based on BICR assessment per RECIST version 1.1.

  Up to Approximately 76 Months

• Stage 1: Duration of response (DoR) based on BICR assessment per RECIST version 1.1.

  Up to Approximately 76 Months

• Stage 1: Disease control rate (DC) based on BICR assessment per RECIST version 1.1.

  Up to Approximately 76 Months

• Stage 1: Overall Survival

  Up to Approximately 76 Months

• Stage 2: Overall Survival

  Up to Approximately 76 Months

Study Arms (7)

Stage 1: Escalation Telisotuzumab Adizutecan + Osimertinib

EXPERIMENTAL

Participants will receive increasing doses of telisotuzumab adizutecan with osimertinib (Osi), as part of the approximately 76 month study duration.

Drug: Telisotuzumab Adizutecan; Drug: Osimertinib (Osi)

Stage 1: Expansion Telisotuzumab Adizutecan Dose A + Osi

EXPERIMENTAL

Participants will receive telisotuzumab adizutecan dose A with Osi, as part of the approximately 76 month study duration.

Drug: Telisotuzumab Adizutecan; Drug: Osimertinib (Osi)

Stage 1: Expansion Telisotuzumab Adizutecan Dose B + Osi

EXPERIMENTAL

Participants will receive telisotuzumab adizutecan dose B with Osi, as part of the approximately 76 month study duration.

Drug: Telisotuzumab Adizutecan; Drug: Osimertinib (Osi)

Stage 1: Expansion Telisotuzumab Adizutecan Dose C + Osi

EXPERIMENTAL

Participants will receive telisotuzumab adizutecan dose C with Osi, as part of the approximately 76 month study duration.

Drug: Telisotuzumab Adizutecan; Drug: Osimertinib (Osi)

Stage 1: Expansion Osi + Chemotherapy + Pemetrexed

EXPERIMENTAL

Participants will receive Osi with chemotherapy followed by Osi with pemetrexed, as part of the approximately 76 month study duration.

Drug: Osimertinib (Osi); Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed

Stage 2: Standared of Care (SOC)

EXPERIMENTAL

Participants will receive SOC, as part of the approximately 76 month study duration.

Drug: Standard of Care; Drug: Osimertinib (Osi)

Stage 2: Optimized Telisotuzumab Adizutecan + Osi

EXPERIMENTAL

Participants will receive the optimized dose of telisotuzumab adizutecan with Osi, as part of the approximately 76 month study duration.

Drug: Telisotuzumab Adizutecan; Drug: Osimertinib (Osi)

Interventions

Carboplatin DRUG

IV

Stage 1: Expansion Osi + Chemotherapy + Pemetrexed

Pemetrexed DRUG

IV

Stage 1: Expansion Osi + Chemotherapy + Pemetrexed

Standard of Care DRUG

Standard of Care

Stage 2: Standared of Care (SOC)

Telisotuzumab Adizutecan DRUG

Intravenous (IV)

Stage 1: Escalation Telisotuzumab Adizutecan + Osimertinib; Stage 1: Expansion Telisotuzumab Adizutecan Dose A + Osi; Stage 1: Expansion Telisotuzumab Adizutecan Dose B + Osi; Stage 1: Expansion Telisotuzumab Adizutecan Dose C + Osi; Stage 2: Optimized Telisotuzumab Adizutecan + Osi

Osimertinib (Osi) DRUG

Oral

Stage 1: Escalation Telisotuzumab Adizutecan + Osimertinib; Stage 1: Expansion Osi + Chemotherapy + Pemetrexed; Stage 1: Expansion Telisotuzumab Adizutecan Dose A + Osi; Stage 1: Expansion Telisotuzumab Adizutecan Dose B + Osi; Stage 1: Expansion Telisotuzumab Adizutecan Dose C + Osi; Stage 2: Optimized Telisotuzumab Adizutecan + Osi; Stage 2: Standared of Care (SOC)

Cisplatin DRUG

IV

Stage 1: Expansion Osi + Chemotherapy + Pemetrexed

Eligibility Criteria

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

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period and prior to dosing of study treatment on Cycle 1 Day 1.
• Must consent to provide recently obtained formalin-fixed, paraffin-embedded (FFPE) tumor tissue (ideally collected during or after locally advanced or metastatic diagnosis) or archived tissue during screening for c-Met immunohistochemistry (IHC) testing and study stratification. c-Met IHC results are required prior to randomization.
• Must have at least one non-irradiated measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If only one measurable lesion exists, it is acceptable to be used (as a target lesion) as long as it has not been previously irradiated and as long as it has not been biopsied within 14 days of the baseline tumor assessment scans.
• Any toxicities from prior systemic anti-cancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level (except for alopecia \[any grade\] or Grade \<= 2 peripheral neuropathy).
• Should not have any major, life-threatening conditions and life expectancy as determined by the investigator should be at least 3 months.
• No prior estimated glomerular filtration rate (EGFR) tyrosine kinase inhibitor (TKI) in the locally advanced and/or metastatic setting (except for when it is allowed on study prior to C1D1). Participants treated with prior EGFR TKI in the adjuvant setting are allowed to enroll provided that \>= 126 months (since last dose of e.g., adjuvant osimertinib) have passed before Cycle 1, Day 1.
• Diagnosis of histologically or cytologically confirmed metastatic/locally advanced non-squamous NSCLC with documented classical EGFR mutation (Exon 19 Del or Exon 21 L858R) either alone or in combination with other EGFR mutations as detected by an Food and Drug Administration (FDA)-approved or other validated test in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory (sites in the US) or an accredited Laboratory (sites outside of the US) in accordance with site standard of care. A copy of the test report documenting the EGFR mutation must be available in the participant records.

You may not qualify if:

• History of interstitial lung disease (ILD), pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan.
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
• Participants has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation.
• History of any malignancy other than disease under study except for
• Malignancy treated with curative intent and with no known active disease present for 2 years before the first dose of study treatment and felt to be at low risk for recurrence by investigator.
• Successfully treated nonmelanoma skin cancer.
• Localized carcinoma in situ of the cervix.
• Breast Cancer; lobular carcinoma in situ or ductal carcinoma in situ that is considered completely cured.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (53)

Ironwood Cancer and Research Centers - Chandler II /ID# 275443

Chandler, Arizona, 85224, United States

RECRUITING

USC Norris Comprehensive Cancer Center /ID# 275343

Los Angeles, California, 90033, United States

RECRUITING

Usc Norris Oncology/Hematology Treatment Center /ID# 278673

Newport Beach, California, 92663, United States

RECRUITING

University Colorado Cancer Center /ID# 275382

Aurora, Colorado, 80045-2517, United States

RECRUITING

Mid Florida Hematology And Oncology Center /ID# 275278

Orange City, Florida, 32763, United States

RECRUITING

Kaiser Permanente Moanalua Medical Center /ID# 275942

Honolulu, Hawaii, 96819, United States

RECRUITING

The Iowa Clinic /ID# 276020

West Des Moines, Iowa, 50266, United States

COMPLETED

Nho - Revive Research Institute /ID# 276115

Lincoln, Nebraska, 68506, United States

RECRUITING

Renown Regional Medical Center /ID# 276049

Reno, Nevada, 89502, United States

RECRUITING

Texas Oncology - South Austin /ID# 276033

Austin, Texas, 78745, United States

RECRUITING

The University of Texas MD Anderson Cancer Center /ID# 275107

Houston, Texas, 77030, United States

RECRUITING

Texas Oncology - Palestine Cancer Center /ID# 276034

Palestine, Texas, 75801, United States

RECRUITING

Virginia Cancer Specialists - Fairfax /ID# 275071

Fairfax, Virginia, 22031, United States

RECRUITING

University of Washington Medical Center /ID# 275866

Seattle, Washington, 98195, United States

RECRUITING

Liverpool Hospital /ID# 276304

Liverpool, New South Wales, 2170, Australia

RECRUITING

The Queen Elizabeth Hospital /ID# 275719

Woodville, South Australia, 5011, Australia

RECRUITING

Austin Health /ID# 275505

Heidelberg, Victoria, 3084, Australia

RECRUITING

St John Of God Murdoch Hospital /ID# 275700

Murdoch, Western Australia, 6150, Australia

RECRUITING

Jessa Ziekenhuis - Campus Virga Jesse /ID# 275585

Hasselt, Limburg, 3500, Belgium

RECRUITING

Universitair Ziekenhuis Leuven /ID# 275586

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

AZ-Delta. /ID# 275753

Roeselare, West-Vlaanderen, 8800, Belgium

RECRUITING

CHU de Liege /ID# 277971

Liège, 4000, Belgium

RECRUITING

The Ottawa Hospital - General Campus /ID# 275611

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Princess Margaret Cancer Centre /ID# 274845

Toronto, Ontario, M5G 2M9, Canada

COMPLETED

Union Hospital Tongji Medical College /ID# 278711

Wuhan, Hubei, 430048, China

RECRUITING

Rabin Medical Center. /ID# 274540

Petah Tikva, Central District, 4941492, Israel

RECRUITING

The Chaim Sheba Medical Center /ID# 274541

Ramat Gan, Tel Aviv, 5265601, Israel

RECRUITING

Rambam Health Care Campus- Haifa /ID# 274542

Haifa, 3109601, Israel

RECRUITING

IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 274948

Rome, Roma, 00144, Italy

RECRUITING

Azienda Ospedaliero Universitaria San Luigi Gonzaga /ID# 275215

Orbassano, Torino, 10043, Italy

RECRUITING

Yokohama Municipal Citizen's Hospital /ID# 275682

Yokohama, Kanagawa, 221-0855, Japan

RECRUITING

Niigata University Medical and Dental Hospital /ID# 275685

Niigata, Niigata, 951-8520, Japan

RECRUITING

Osaka Medical And Pharmaceutical University Hospital /ID# 275684

Takatsuki, Osaka, 569-8686, Japan

RECRUITING

Shizuoka Cancer Center /ID# 278082

Sunto-gun, Shizuoka, 411-8777, Japan

RECRUITING

Juntendo University Hospital /ID# 276424

Bunkyo-ku, Tokyo, 113-8431, Japan

RECRUITING

National Cancer Center Hospital /ID# 275678

Chuo-Ku, Tokyo, 104-0045, Japan

RECRUITING

Unidade Local de Saude de Braga, EPE /ID# 275394

Braga, 4710-243, Portugal

RECRUITING

Unidade Local de Saude de Santo Antonio /ID# 275387

Porto, 4099-003, Portugal

RECRUITING

Hospital Cuf Porto /ID# 275395

Porto, 4100-180, Portugal

RECRUITING

National Cancer Centre Singapore /ID# 275986

Singapore, Central Singapore, 169611, Singapore

RECRUITING

National University Hospital /ID# 275988

Singapore, 119074, Singapore

RECRUITING

Inje University Haeundae Paik Hospital /ID# 275388

Busan, Busan Gwang Yeogsi, 48108, South Korea

RECRUITING

Chungbuk National University Hospital /ID# 275768

Cheongju-si, North Chungcheong, 28644, South Korea

RECRUITING

Yonsei University Health System Severance Hospital /ID# 275384

Seoul, Seoul Teugbyeolsi, 03722, South Korea

RECRUITING

Asan Medical Center /ID# 275600

Seoul, Seoul Teugbyeolsi, 05505, South Korea

RECRUITING

Samsung Medical Center /ID# 278083

Seoul, Seoul Teugbyeolsi, 06351, South Korea

RECRUITING

Hospital Clinic de Barcelona /ID# 275476

Barcelona, 08036, Spain

RECRUITING

Hospital General Universitario Gregorio Maranon /ID# 275475

Madrid, 28007, Spain

RECRUITING

Hospital Universitario 12 de Octubre /ID# 277698

Madrid, 28041, Spain

RECRUITING

Instituto Valenciano de Oncología /ID# 275471

Valencia, 46009, Spain

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 275293

Kaohsiung City, 807, Taiwan

RECRUITING

National Taiwan University Cancer Center (Ntucc) /ID# 275291

Taipei, 106, Taiwan

RECRUITING

Taipei Veterans General Hospital /ID# 275292

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Standard of Care; osimertinib; Cisplatin; Carboplatin; Pemetrexed

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 5, 2025
• Study Start: August 3, 2025
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): November 1, 2036
• Last Updated: June 8, 2026

Record last verified: 2026-06

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/

Locations

BE (4); IL (3); CA (2); JP (6); KR (5); TW (3); US (14); PT (3); CN (1); SG (2); IT (2); AU (4); ES (4)