Recruiting
Phase 2
Phase 3

Telisotuzumab & Osi

Sponsor:

AbbVie

Code:

NCT07005102

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard of Care

Telisotuzumab Adizutecan

Osimertinib (Osi)

Cisplatin

Carboplatin

Study Details

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

Study ID

NCT07005102

Start date

Aug 3, 2025

Status verified date

Jun, 2026

Completion date

Nov, 2036

Anticipated

Primary completion date

Dec, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

1. 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.
2. Successfully treated nonmelanoma skin cancer.
3. Localized carcinoma in situ of the cervix.
4. Breast Cancer; lobular carcinoma in situ or ductal carcinoma in situ that is considered completely cured.

Study Design

Enrollment

854 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stage 1: Escalation Telisotuzumab Adizutecan + Osimertinib

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

experimental: Stage 1: Expansion Telisotuzumab Adizutecan Dose A + Osi

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

experimental: Stage 1: Expansion Telisotuzumab Adizutecan Dose B + Osi

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

experimental: Stage 1: Expansion Telisotuzumab Adizutecan Dose C + Osi

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

experimental: Stage 1: Expansion Osi + Chemotherapy + Pemetrexed

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

experimental: Stage 2: Standared of Care (SOC)

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

experimental: Stage 2: Optimized Telisotuzumab Adizutecan + Osi

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

Interventions

Standard of Care

Standard of Care

Telisotuzumab Adizutecan

Intravenous (IV)

Osimertinib (Osi)

Oral

Cisplatin

IV

Carboplatin

IV

Pemetrexed

IV

Primary outcome measure

  • Stage 1: Objective Response (OR) Based on Blinded Independent Central Review (BICR) Assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Up to Approximately 76 Months ]
  • Stage 2: Progression-free survival (PFS) based on BICR assessment per RECIST version 1.1. [ Time Frame: Up to Approximately 76 Months ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Approximately 76 Months ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

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

Recruiting

Chandler, Arizona, United States, 85224

USC Norris Comprehensive Cancer Center /ID# 275343

Recruiting

Los Angeles, California, United States, 90033

Usc Norris Oncology/Hematology Treatment Center /ID# 278673

Recruiting

Newport Beach, California, United States, 92663

University Colorado Cancer Center /ID# 275382

Recruiting

Aurora, Colorado, United States, 80045-2517

Mid Florida Hematology And Oncology Center /ID# 275278

Recruiting

Orange City, Florida, United States, 32763

Kaiser Permanente Moanalua Medical Center /ID# 275942

Recruiting

Honolulu, Hawaii, United States, 96819

Nho - Revive Research Institute /ID# 276115

Recruiting

Lincoln, Nebraska, United States, 68506

Renown Regional Medical Center /ID# 276049

Recruiting

Reno, Nevada, United States, 89502

Texas Oncology - South Austin /ID# 276033

Recruiting

Austin, Texas, United States, 78745

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

Recruiting

Houston, Texas, United States, 77030

Texas Oncology - Palestine Cancer Center /ID# 276034

Recruiting

Palestine, Texas, United States, 75801

Virginia Cancer Specialists - Fairfax /ID# 275071

Recruiting

Fairfax, Virginia, United States, 22031

University of Washington Medical Center /ID# 275866

Recruiting

Seattle, Washington, United States, 98195

The Ottawa Hospital - General Campus /ID# 275611

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

More Information

Sponsor

AbbVie

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • Non-Squamous Non-Small Cell Lung Cancer
  • Telisotuzumab Adizutecan
  • Osimertinib
  • Cisplatin
  • Carboplatin
  • Pemetrexed
  • ABBV-400
  • Stand of Care
  • Cancer
  • Chemotherapy
  • Platinum Chemotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-06-08.