Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer

This study is looking at a new medicine called TAK-788, also known as mobocertinib, for adults who have a type of lung cancer called non-small cell lung cancer. The main goals are to find the right amount of medicine to give (the best dose), understand any possible side effects, and learn how the body uses and gets rid of TAK-788. Participants will take TAK-788 capsules, sometimes along with chemotherapy. This research is important because it could help doctors understand if TAK-788 is a safe and effective new treatment option for people with this specific type of cancer.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Takeda

Enrolment target

334

Start

16 Jun 2016

Estimated completion

31 Oct 2026

Carcinoma, Non-Small-Cell Lung

What is this study about?

This study is about a new medicine called TAK-788, which is also known as mobocertinib. It's being tested in adults who have a type of lung cancer called non-small cell lung cancer. The main idea behind this research is to see if TAK-788 can be a helpful treatment. Researchers are especially interested in learning about any side effects the medicine might cause, how the body processes it, and finding the best dose to give people.

The study will happen in different stages. Initially, a small group of people will help researchers figure out the safest dose of TAK-788. Once that's established, larger groups will take the medicine, sometimes along with chemotherapy, to see how well it works against the cancer. They will also look at whether the medicine causes different effects in people from different backgrounds.

This research is important because it could lead to new treatment options for non-small cell lung cancer, especially for those with specific changes in their cancer cells. Doctors are always looking for better ways to treat cancer, and studies like this help them understand if new medicines are safe and effective.

Key takeaways

This study is testing a new medicine called TAK-788 (mobocertinib) for lung cancer.
It aims to find the safest dose and check for side effects.
Some participants will take the medicine with chemotherapy.
You will have regular check-ups and tests if you join.
Participation is voluntary, and you can leave at any time.

Who may be eligible?

To join this study, generally, you'd need to be an adult (18 or older) with non-small cell lung cancer that has spread or is advanced, or another type of solid tumour. Your cancer would need to be visible on scans, and doctors would need to be able to take a sample of your tumour for testing.

You also need to be fit enough for the study, meaning you can generally take care of yourself without much help. Your vital organs like your heart and liver would need to be working well. Additionally, you should be expected to live for at least another three months.

Specific parts of the study might have additional requirements, for example, if your cancer has certain genetic changes within the tumour, or if you've tried other treatments before. The study team can check all these details with you.

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.

Are you 18 years old or older?
Do you have advanced non-small cell lung cancer or another solid tumour?
Has your doctor confirmed your cancer can be measured on a scan?
Are you generally well enough to do your daily activities?
Do your main organs (like your heart and liver) work properly?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be taking TAK-788 capsules. Sometimes, this medicine might be taken together with chemotherapy. You would keep taking the capsules unless you or your doctor decide it's best for you to stop. The study team will give you other medicines to help prevent certain side effects, like diarrhoea.

You will have regular visits with the study team. These visits will involve various tests, such as blood tests, scans, and possibly heart checks (ECGs), to monitor your health, see how the medicine is working, and check for any side effects. These appointments help the doctors keep track of your condition throughout the study. The total length of your participation will depend on the specific stage of the study and how you respond to the treatment.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study could be that TAK-788 might help treat your cancer, especially if other treatments haven't worked well. However, because this is a new medicine, there's no guarantee it will help you. Potential risks include experiencing side effects from TAK-788; the study team will monitor you closely for these. You also have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (62)

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

Brookwood Medical Center
Verified postcode
Birmingham, United States
Banner MD Anderson Cancer Center
Verified postcode
Gilbert, United States
The Oncology Institute of Hope and Innovation - West Tucson
Verified postcode
Tucson, United States
City of Hope Comprehensive Cancer Center - Duarte
Verified postcode
Duarte, United States
Compassionate Cancer Care - Fountain Valley
Verified postcode
Fountain Valley, United States
University of California San Diego Moores Cancer Center
Verified postcode
La Jolla, United States
Pacific Shores Medical Group-Long Beach Elm
Verified postcode
Long Beach, United States
Cancer and Blood Specialty Clinic
Verified postcode
Los Alamitos, United States
University of California Irvine Health Chao Family Comprehensive Cancer Center
Verified postcode
Orange, United States
Stanford Cancer Center - Palo Alto
Verified postcode
Palo Alto, United States
SLO Oncology and Hematology Health Center
Verified postcode
San Luis Obispo, United States
The Oncology Institute of Hope and Innovation
Verified postcode
Whittier, United States

Common questions

What is TAK-788?

TAK-788, also known as mobocertinib, is a new medicine being tested for a type of lung cancer and other solid tumours.

Why are doctors doing this study?

Doctors want to find the safest and most effective dose of TAK-788, understand its side effects, and see how it works against cancer.

Will I get chemotherapy if I join?

Some participants will take TAK-788 with chemotherapy, while others may take it alone. The study team will explain your specific plan.

Can I stop taking part if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect your regular medical care.

Who can join this study?

Adults with advanced non-small cell lung cancer or other solid tumours, who meet specific health and cancer criteria, may be eligible. Your doctor will check if you qualify.