AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

KontRASt-R: An open-label, multi-center, rollover study for participants who have been previously enrolled into a Novartis-sponsored opnurasib (JDQ443) study and are continuing to benefit from opnurasib as a single agent or in combination with other study treatments

This study, called KontRASt-R, is for people with advanced lung cancer or other advanced solid cancers that have a specific genetic change known as KRAS G12C. It's an extension study for participants who have already been taking a medicine called opnurasib (also known as JDQ443) in a previous Novartis study and are finding it helpful. The main goal is to keep track of how many people continue to take opnurasib, either by itself or with other study drugs, and for how long. Researchers will also be checking carefully for any side effects and how severe they are, as well as if participants need to pause, reduce, or stop their treatment. This helps make sure the treatment is safe and tolerable over a longer period.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Novartis Pharma AG

Enrolment target

Start

08 Jun 2026

Locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer advanced solid tumors harboring the KRAS G12C mutation.

What is this study about?

This research study, named KontRASt-R, is designed for people who have certain advanced cancers. Specifically, it's for those with advanced non-small cell lung cancer or other advanced solid cancers (meaning they aren't blood cancers) that have a particular genetic fault called a KRAS G12C mutation. This mutation is like a tiny error in the cancer cell's instruction manual that can make it grow.

This study is a bit different because it's a 'rollover' study. This means it's for participants who were already part of a previous Novartis study testing a new drug called opnurasib (you might also see it called JDQ443). If you were in one of those earlier studies and opnurasib was helping you, this study allows you to continue receiving it. The main purpose is to see how many people continue to benefit from opnurasib, either on its own or with other study medications, and for how long they keep taking it.

The researchers are also very interested in the safety of opnurasib over a longer period. They will carefully monitor any side effects that might happen, how bad they are, and if participants need to change their dose or stop the treatment for any reason. This information is crucial for understanding the overall safety and how well people tolerate the medicine if taken for a longer time.

Key takeaways

This study is for people with specific advanced cancers (KRAS G12C mutation).
It's an extension for those already receiving opnurasib in a previous Novartis study.
The main goals are to see how long people stay on opnurasib and to monitor safety.
Participation involves ongoing treatment and regular check-ups.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women can participate.

Most importantly, you must have previously taken part in another Novartis study looking at opnurasib (JDQ443) and found that the treatment was helping you.

Your cancer must be advanced, either locally advanced (meaning it has grown into nearby tissues) or metastatic (meaning it has spread to other parts of the body). It also needs to have a specific genetic change called a KRAS G12C mutation.

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 advanced solid cancer with a KRAS G12C mutation?
Were you previously enrolled in a Novartis study involving opnurasib (JDQ443)?
Was opnurasib found to be beneficial for you in that previous study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive opnurasib, either on its own or with other study medications, as decided by the study doctors. You will have regular visits with the study team. These visits will involve check-ups, blood tests, and possibly other scans or tests to see how you are doing and if the treatment is still working. The doctors will also carefully monitor you for any side effects and manage them appropriately. The total duration of your participation will depend on how you respond to the treatment and your health, as long as the treatment continues to help you.

Potential risks and benefits

A potential benefit of joining this study is that you may continue to receive a treatment that has already shown promise for your cancer, which could help manage your condition for longer. However, like all medicines, opnurasib can have side effects, and some people may experience new or worsening side effects over time. There's also no guarantee that the treatment will continue to work for everyone. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Italy
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Unverified
France
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Unverified
Belgium

Common questions

What kind of cancer is this study for?

This study is for advanced non-small cell lung cancer or other advanced solid tumors that have a specific gene change called KRAS G12C.

Why is this study only for people already in another study?

This is a 'rollover' study, meaning it allows participants who were already taking opnurasib in a previous Novartis study and benefiting from it to continue receiving the treatment.

What is opnurasib?

Opnurasib (also known as JDQ443) is a new medicine being studied for certain types of cancer. It's not yet approved for general use.

What will the study team be looking for?

They will mostly be watching to see how long people continue to take opnurasib and checking carefully for any side effects to make sure the treatment is safe for long-term use.

Can I stop participating in the study if I want to?

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