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Lifeline for cancer patients: rollover study extends access to targeted drug opnurasib

NCT ID NCT07468071

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 19 times

Summary

This rollover study allows up to 40 people with KRAS G12C-mutated lung or other solid tumors who are already benefiting from opnurasib in a Novartis trial to keep receiving the drug. Participants continue their current dose of opnurasib alone or with TNO155 or trametinib. The goal is to provide ongoing treatment access and monitor long-term safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
opnurasib (JDQ443) alone or with TNO155 or trametinib
What this could lead to
If successful, this study shows that long-term use of opnurasib is safe and helps control KRAS G12C-mutated cancers.
What could go wrong
This is a small rollover study (40 people) with no control group, so it cannot prove the drug works better than other options. Side effects may still occur.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Participant is currently enrolled in a pre-defined Novartis-sponsored study and is receiving opnurasib as single agent or in combination with other study treatment. * Participant has received at least 6 cycles of opnurasib in a parent study. * Participant is currently deriving clinical benefit from the study treatment, as determined by the Investigator. * Participants currently receiving treatment in one of the KontRASt studies, including those who have not experienced disease progression or who are continuing treatment beyond initial disease progression, may be eligible to enroll in the rollover study if, in the Investigator's judgment, they are expected to continue deriving clinical benefit from treatment with opnurasib (alone or in combination). Clinical benefit, as assessed by the Investigator, may be reflected by delayed disease progression, improvement in disease-related symptoms, improvement in overall quality of life, or a combination of these factors. Key Exclusion Criteria: * Participant has been permanently discontinued from opnurasib in the parent protocol for any reason other than enrollment in the CJDQ443B12105B study. * Participant is not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol. * Participant currently has unresolved toxicities for which opnurasib dosing has been interrupted in the parent study. * Participant has known actionable mutations, such as EGFR-sensitizing mutation, ALK rearrangement, or others, identified during the participation in the parent trial for which there are available treatment options. Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

colorectal neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Sint-Niklaas, Oost Vlaanderen, 9100, Belgium

  • Novartis Investigative Site

    RECRUITING

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Changsha, Hunan, 410013, China

  • Novartis Investigative Site

    RECRUITING

    Copenhagen, 2100, Denmark

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Bron, 69677, France

  • Novartis Investigative Site

    RECRUITING

    Villejuif, 94800, France

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Milan, MI, 20133, Italy

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Milan, MI, 20162, Italy

  • Novartis Investigative Site

    RECRUITING

    Roma, RM, 00128, Italy

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Kashiwa, Chiba, 2778577, Japan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Koto Ku, Tokyo, 1358550, Japan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Kuching, Sarawak, 93586, Malaysia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28050, Spain

  • Novartis Investigative Site

    RECRUITING

    Valencia, 46010, Spain