RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

This research study is investigating a new medication called Divarasib for people with advanced non-small cell lung cancer that has a particular genetic mutation called KRAS G12C. This type of lung cancer hasn't been treated yet with other advanced-stage therapies. The main goals are to find out if Divarasib is safe, how well the body handles it, and if it can help shrink the cancer. Researchers will test Divarasib by itself and in combination with other established cancer treatments like Pembrolizumab, Carboplatin, Cisplatin, and Pemetrexed. The study is currently in its early stages (Phase 1 and Phase 2), meaning it's primarily focused on safety and finding the right dose, as well as getting an early idea of how effective it might be.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Hoffmann-La Roche

Enrolment target

320

Start

20 Jun 2023

Estimated completion

29 Jan 2032

Non-Small Cell Lung Cancer

What is this study about?

This research study is about helping people with a type of lung cancer called non-small cell lung cancer (NSCLC). Specifically, it's for those whose cancer has spread (advanced or metastatic) and has a special change in its genes, known as a 'KRAS G12C mutation'. This mutation is like a specific instruction within the cancer cells that helps them grow. The study is trying out a new drug called Divarasib, which is designed to block this specific instruction, hoping to stop the cancer from growing.

Researchers want to see if Divarasib is safe to use and how the body handles it. They will also be looking to see if it can make tumours smaller. They will test Divarasib on its own and also combine it with other well-known cancer treatments that you might have heard of, such as Pembrolizumab, Carboplatin, Cisplatin, and Pemetrexed. The idea is to find out the best way to use Divarasib to help patients.

This study is conducted in two early stages, called Phase 1 and Phase 2. Phase 1 is mainly about making sure the new drug is safe and finding the best dose. Phase 2 then checks if the drug shows promise in treating the cancer and continues to monitor safety. Studies like this are really important because they help us find new and better ways to treat cancer in the future.

Key takeaways

This study is for advanced non-small cell lung cancer with a specific gene change (KRAS G12C).
It tests a new drug, Divarasib, alone or with other cancer treatments.
The main goals are to check safety and see if it shrinks tumours.
It's an early-stage study (Phase 1/2) focused on finding effective and safe treatments.
Participation involves regular clinic visits, tests, and taking study medication.
You can stop participating at any time.

Who may be eligible?

To join this study, doctors will need to confirm two main things about your cancer: first, that it is non-small cell lung cancer that has spread (locally advanced and cannot be removed by surgery, or metastatic), and second, that it has a specific gene change called a KRAS G12C mutation. Your cancer also shouldn't have been treated for this advanced stage before with other systemic cancer treatments. You'll need to provide a recent sample of your tumour tissue for testing.

Also, your general health needs to be good enough to take part. Doctors use a scale called ECOG to check this, and you'd need to score 0 or 1, meaning you're mostly active and able to look after yourself. Your cancer also needs to be measurable, meaning doctors can clearly see and track its size.

There are also some reasons why you might not be able to join. For example, if you have another significant cancer that needed treatment within the last five years (other than skin cancer that's been removed). You also couldn't join if you've had a type of cancer treatment called a 'KRAS G12C inhibitor' before, or if you have certain existing lung or heart conditions, or uncontrolled active infections like tuberculosis. If your brain metastases are causing symptoms or need immediate treatment, that could also make you ineligible for some parts of the study.

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 I have advanced non-small cell lung cancer?
Has my cancer been tested for a KRAS G12C gene change?
Have I not received prior systemic treatment for my advanced lung cancer?
Am I generally well enough to be active most of the time?
Do I have recent tumour tissue available for testing?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study drug, Divarasib, possibly along with other standard cancer treatments. This could involve taking tablets, having intravenous (IV) infusions through a drip, or a combination of both. You would have regular visits to the clinic for check-ups, blood tests, scans (like CT or MRI) to see how the cancer is responding, and to monitor for any side effects. The exact schedule of visits and treatments would be explained to you in detail by the study team.

The study would continue for as long as the treatment is helping you and you are not experiencing severe side effects. Even after you stop the study treatment, the research team would continue to follow up with you for a period to see how you are doing. The total duration of your participation, including follow-up, would vary depending on your individual response and overall health.

Potential risks and benefits

Taking part in a clinical trial means you might be among the first to receive a new treatment that could potentially help your cancer. However, there's no guarantee it will work for everyone, and it's also possible that the new drug might not be more effective than standard treatments. As with any medication, Divarasib and the other drugs in this study can have side effects, some of which could be serious. The research team will carefully monitor you for any side effects and will explain all known risks before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (71)

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

City of Hope National Medical Center
Verified postcode
Duarte, United States· Withdrawn
City of Hope - Seacliff
Verified postcode
Huntington Beach, United States· Withdrawn
City of Hope at Irvine Lennar
Verified postcode
Irvine, United States· Withdrawn
UCSD Moores Cancer Center
Verified postcode
La Jolla, United States· Withdrawn
City of Hope - Long Beach Elm
Verified postcode
Long Beach, United States· Withdrawn
Yale Cancer Center
Verified postcode
New Haven, United States· Recruiting
Florida Cancer Specialists - SOUTH - SCRI - PPDS
Verified postcode
Fort Myers, United States· Recruiting
Florida Cancer Specialists - NORTH - SCRI - PPDS
Verified postcode
St. Petersburg, United States· Recruiting
Florida Cancer Specialists - EAST - SCRI - PPDS
Verified postcode
West Palm Beach, United States· Recruiting
NYU Langone Hospital - Long Island
Verified postcode
Mineola, United States· Recruiting
NYU Cancer Center
Verified postcode
New York, United States· Recruiting
Mount SInai Medical Center
Verified postcode
New York, United States· Recruiting

Common questions

What is a KRAS G12C mutation?

It's a specific change in the genes of your cancer cells that can make them grow. This study drug is designed to target this particular change.

What does 'non-small cell lung cancer' mean?

It's the most common type of lung cancer. This study is for when it's advanced or has spread to other parts of the body.

What phase is this study?

This study is in Phase 1 and Phase 2. This means it's still in the early stages, focusing on safety and finding the right dose, and seeing if the treatment shows promise.

Will I get the new drug or the standard treatment?

Depending on the part of the study, you might receive the new drug (Divarasib) on its own or in combination with standard cancer treatments. The study team will explain your specific treatment plan.

Can I still get my usual cancer care if I join?

Yes, your participation in the study is voluntary, and you can withdraw at any time. This will not affect your right to receive standard medical care.

How to find out more

Reference Study ID Number: BO44426 https://forpatients.roche.com/

global-roche-genentech-trials@gene.com 888-662-6728 (U.S. and Canada) Official trial record

Always speak to your GP or specialist before deciding to take part in a study.