Study of telisotuzumab adizutecan with osimertinib as first treatment for adults with advanced or metastatic EGFR-mutated non-small cell lung cancer

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What is this study about?

This study focuses on patients with Non-Squamous Non-Small Cell Lung Cancer that is locally advanced and cannot be surgically removed, or has spread to other parts of the body (metastatic). The cancer in these patients must have specific genetic changes called EGFR mutations. The study will test a combination of two medications: telisotuzumab adizutecan (also known as ABBV-400), which is given through an intravenous infusion, and osimertinib, which is taken as a tablet by mouth.

The purpose of this research is to evaluate how well these two medications work together as a first treatment option for this type of lung cancer, and to determine the best dose of telisotuzumab adizutecan when combined with osimertinib. The study is divided into two phases. During treatment, patients will receive both medications for up to 40 weeks.

Telisotuzumab adizutecan belongs to a group of drugs called antibody-drug conjugates, which are designed to target and deliver medication directly to cancer cells. The study will look at how the treatment affects the cancer’s growth and spread, and how long patients live without their disease getting worse. The research will also monitor any side effects that may occur during treatment.

1 Initial health assessment

Your health status will be evaluated using the Eastern Cooperative Oncology Group (ECOG) scale, which measures physical ability to perform daily activities

A tissue sample from your tumor will be tested for c-Met protein levels

Your tumor will be measured using imaging scans to establish a baseline

2 Treatment assignment

You will be randomly assigned to receive either:

Option 1: Telisotuzumab adizutecan given through an intravenous infusion, combined with osimertinib taken by mouth

Option 2: Osimertinib taken by mouth alone

3 Treatment period

Your treatment will be given in cycles

Regular imaging scans will be performed to monitor your tumor response

Physical examinations and blood tests will be conducted throughout the treatment

At week 12, you will complete quality of life questionnaires about your physical functioning and lung cancer symptoms

4 Monitoring period

Your response to treatment will be evaluated using imaging scans

Side effects will be monitored and recorded

The study team will track how long the treatment keeps your cancer under control

Your overall health status will be monitored throughout the study period

5 Long-term follow-up

Your health status will continue to be monitored after treatment completion

Regular check-ups will be scheduled to track your long-term progress

The study will continue until December 2031

Who Can Join the Study?

  • Age requirement: Adults aged 18 years and older
  • Physical condition: Must have an ECOG performance status of 0 or 1 (meaning able to perform daily activities with minimal or no limitations)
  • Must provide a tumor tissue sample for testing during screening period. The sample should be either recently collected or from previous examination archives
  • Must have at least one measurable tumor that has not been treated with radiation. If there is only one tumor, it should not have had a biopsy within 14 days of the initial assessment scans
  • Any side effects from previous cancer treatments must have improved to mild level or returned to baseline condition (except for hair loss or mild nerve problems in hands/feet)
  • Must have a life expectancy of at least 3 months as determined by the doctor
  • Both men and women can participate
  • Must not have any major life-threatening conditions
  • Must be willing to undergo c-Met IHC testing (a laboratory test that looks for specific proteins in cancer cells) before being assigned to treatment groups

Who Cannot Join the Study?

  • History of squamous cell lung cancer (a specific type of lung cancer with different cell characteristics)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Prior treatment with telisotuzumab adizutecan
  • Known hypersensitivity (severe allergic reaction) to the study medications
  • Significant heart problems, including uncontrolled high blood pressure or heart failure
  • Severe liver or kidney dysfunction
  • Active or chronic infections, including hepatitis B, hepatitis C, or HIV
  • Other active cancers requiring treatment (except for certain skin cancers or in situ cervical cancer)
  • Major surgery within 4 weeks before starting the study treatment
  • Pregnancy or breastfeeding
  • Any medical condition that could interfere with the study treatment or put the patient at risk
  • Unable to swallow oral medications
  • Participation in another clinical trial within 30 days before starting this study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Centre hospitalier universitaire de Liege Liege Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Algemeen Ziekenhuis Delta Roeselare Belgium
Fundacion Instituto Valenciano De Oncologia Valencia Spain
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Ospedale San Raffaele S.r.l. Milan Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Hospital Clinic De Barcelona Barcelona Spain
Jessa Ziekenhuis Hasselt Belgium
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Hospital CUF Porto S.A. Porto Portugal
Iafjqq Ijkrzacw Fdoxlgkwabtnf Ogshhqxlxby Rome Italy
Iuxwhats Ccwyow Dgpdfpyxacjocckzw L'hospitalet De Llobregat Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
08.09.2025
Italy Italy
Recruiting
08.09.2025
Portugal Portugal
Recruiting
08.09.2025
Spain Spain
Recruiting
08.09.2025

Trial locations

Telisotuzumab adizutecan is an investigational cancer medication that targets specific proteins found on cancer cells. It is designed to deliver anti-cancer agents directly to tumor cells, potentially helping to treat non-small cell lung cancer. This medication is being studied as part of a combination therapy for patients with specific genetic mutations in their lung cancer.

Osimertinib is a targeted therapy medication used to treat non-small cell lung cancer. It works by blocking a specific protein (EGFR) that helps cancer cells grow. This medication is already approved for treating lung cancer patients whose tumors have certain genetic changes in the EGFR gene. It is taken as a daily oral tablet.

The trial studies these two medications used together as a combination treatment for patients who have not previously received treatment for their advanced lung cancer with EGFR mutations. This combination approach aims to potentially improve the effectiveness of treatment compared to using single medications alone.

Investigated diseases:

Non-Squamous Non-Small Cell Lung Cancer – A type of lung cancer that begins in the larger lung cells and develops in the outer parts of the lungs. It is characterized by abnormal growth of lung cells that are not of the squamous type. The cancer typically starts in the cells that line the airways of the lungs and can spread to other parts of the body. This disease progresses by forming masses in lung tissue and can affect nearby lymph nodes. Non-squamous NSCLC includes adenocarcinoma and large cell carcinoma subtypes.

Trial ID:
2024-518586-10-00
Protocol code:
M25-287
Trial Phase:
Therapeutic use (Phase IV)

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