Recruiting

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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
Step 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 trial?

9 criteria

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 trial?

13 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Algemeen Ziekenhuis Delta
Verified
Roeselare, Belgium
Centre hospitalier universitaire de Liege
Verified
Liege, Belgium
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium

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Investigated drugs

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.

What is already known about the treatment

Telisotuzumab Adizutecan
An investigational antibody-drug conjugate administered intravenously that targets c-Met protein in cancer cells, specifically developed for treating non-squamous non-small cell lung cancer (NSCLC) with EGFR mutations. This medication is currently being studied in Phase 2/3 clinical trials in combination with osimertinib as a first-line treatment for locally advanced or metastatic NSCLC, representing a novel targeted therapy approach in oncology. The drug works by delivering a potent cytotoxic agent directly to cancer cells that express c-Met, potentially offering a more precise treatment option with reduced effects on healthy tissues.
Osimertinib
An oral targeted therapy medication belonging to the class of tyrosine kinase inhibitors (TKIs) that specifically blocks the activity of mutated EGFR in non-small cell lung cancer cells. This medication is already approved and widely used as a standard first-line treatment for EGFR-mutated NSCLC, working by preventing cancer cell growth and survival signals. The drug has demonstrated significant efficacy in treating NSCLC patients with EGFR mutations, showing improved outcomes compared to older generation EGFR inhibitors, with the ability to cross the blood-brain barrier for treating brain metastases.

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.