Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer

This research is looking into a new way to treat metastatic non-small cell lung cancer. Doctors are combining two medicines, amivantamab and docetaxel, to see if they work better together. The first part of the study aims to find the safest and most effective dose of this combination. The second part will then check how well this chosen dose shrinks tumours in people whose cancer has progressed despite other treatments, including platinum-based chemotherapy and immunotherapy. The study is for adults with this type of lung cancer. It's a way for doctors to learn more about new treatment options.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Janssen Research & Development, LLC

Enrolment target

Start

23 Jul 2024

Estimated completion

09 Jun 2026

Carcinoma, Non-Small-Cell Lung

What is this study about?

This study is about finding better ways to treat a type of lung cancer called non-small cell lung cancer, especially when it has spread to other parts of the body (this is called metastatic cancer). Doctors are exploring a new combination of two medicines: amivantamab and docetaxel.

The research has two main parts. In the first part, the focus is on safety and finding the right dose. Imagine trying to find the perfect amount of two ingredients in a recipe – too little might not work, too much might cause problems. The doctors want to find the best 'recipe' for these two medicines together. Once they find this ideal combination dose, they move to the second part of the study.

The second part will then look at how well this chosen combination dose works to shrink the cancer. This part is for people with non-small cell lung cancer that has continued to grow even after they've had common treatments like chemotherapy (using platinum-based drugs) and immunotherapy. The study is a chance to see if this new combination could be a helpful treatment option in the future.

Key takeaways

This study is for adults with advanced non-small cell lung cancer.
It's testing a combination of two cancer drugs: amivantamab and docetaxel.
The primary goal is to find the best dose and see how well this combination works.
Participation involves regular hospital visits, tests, and closely monitoring your health.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To be able to join this study, you would need to have non-small cell lung cancer that has been confirmed by tests and has spread to other parts of your body. You also need to have at least one tumour that doctors can measure.

Even if you've had cancer in the past that isn't the lung cancer being studied, you might still be eligible if it's unlikely to affect how this study works. If you've had brain tumours that have been treated and are stable, and you're not on high doses of medication for them, you might also be able to take part. Generally, you need to be able to do your daily activities fairly well.

Some things would mean you couldn't join. For example, if you have certain genetic changes (called oncogenic driver mutations) in your cancer (for the second part of the study), or if you've had recent radiation therapy. You also can't have certain lung conditions (like interstitial lung disease), or severe allergies to the medicines being tested or similar drugs.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have non-small cell lung cancer that has spread?
Do you have at least one tumour that doctors can measure?
Have you used platinum-based chemotherapy and immunotherapy, and your cancer has progressed?
Are you generally well enough to go about your daily activities?
Do you have any severe allergies to cancer medicines or certain lung conditions?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive two medicines: amivantamab and docetaxel, given together. The doctors will closely monitor your health and how the treatment affects you. This will involve regular visits to the hospital for assessments, blood tests, and scans to check your cancer.

The full duration of your participation would depend on how your body responds to the treatment. You would continue receiving the study treatment for as long as it is helping you and if you're not experiencing severe side effects. There might also be follow-up appointments after you stop the treatment to monitor your long-term health.

The study involves regular check-ups, scans, and possibly other procedures to ensure your safety and to see how the combination therapy is working. The exact schedule of visits and tests will be explained in detail by the study team.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that the combination of amivantamab and docetaxel might help control your lung cancer, especially if other treatments haven't worked well for you. However, there's no guarantee that it will be effective for everyone. As with all medicines, there could be side effects or allergic reactions from amivantamab and docetaxel, which the study team will discuss with you in detail. Your safety is very important, and you would be closely monitored throughout the study. Most importantly, you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

UCI Health Irvine Hospital
Verified postcode
Irvine, United States
Cancer and Blood Specialty Clinic
Verified postcode
Los Alamitos, United States
University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
Verified postcode
Orange, United States
Oncology Hematology Associates
Verified postcode
Springfield, United States
Hunterdon Hematology Oncology
Verified postcode
Flemington, United States
Virginia Cancer Specialists
Verified postcode
Fairfax, United States
Changhua Christian Hospital
Verified postcode
Changhua, Taiwan
Kaohsiung Medical University Hospital
Verified postcode
Kaohsiung City, Taiwan
Chi Mei Medical Center Liu Ying
Unverified
Liou Ying Township, Taiwan
Taichung Veterans General Hospital
Verified postcode
Taichung, Taiwan
National Taiwan University Hospital
Verified postcode
Taipei, Taiwan
Taipei Medical University
Verified postcode
Taipei, Taiwan

Common questions

What is 'metastatic non-small cell lung cancer'?

This is a type of lung cancer that has spread from the lungs to other parts of the body.

What are amivantamab and docetaxel?

These are two different medicines used to treat cancer. Amivantamab is a newer type of drug that targets specific signals on cancer cells, and docetaxel is a type of chemotherapy.

Why are doctors combining these two medicines?

Doctors hope that by using these two medicines together, they might be more effective at fighting the cancer than either one alone.

Will this study cure my cancer?

This study is designed to see how well the treatment shrinks or controls cancer. While treatments can be very effective, a cure is not guaranteed.

How long will I be in the study if I join?

The length of your participation depends on how you respond to the treatment and if you experience side effects. It varies for each person.