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NCT07468071From ClinicalTrials.govRecruiting

Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments

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

  • Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer
  • Advanced Solid Tumors Harboring the KRAS G12C Mutation

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Novartis Pharmaceuticals
Enrolment target
40
Started
8 June 2026
Main results due
11 June 2029
Study sites
21
Registry updated
24 September 2026

Can you take part?

  • Ages 18 years to 100 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

The purpose of this study is to allow continued access to opnurasib (JDQ443) to participants who are benefitting from treatment with opnurasib as a single agent or in combination with other study treatments in pre-defined Novartis-sponsored opnurasib studies and to continue to assess safety in these participants.

Study sites(21)

  • Novartis Investigative Site

    Sint-Niklaas, Oost Vlaanderen, Belgium

    Active, not recruiting

  • Novartis Investigative Site

    Leuven, Belgium

    Recruiting

  • Novartis Investigative Site

    Montreal, Quebec, Canada

    Active, not recruiting

  • Novartis Investigative Site

    Sherbrooke, Quebec, Canada

    Active, not recruiting

  • Novartis Investigative Site

    Guangzhou, Guangdong, China

    Active, not recruiting

  • Novartis Investigative Site

    Changsha, Hunan, China

    Active, not recruiting

  • Novartis Investigative Site

    Copenhagen, Denmark

    Recruiting

  • Novartis Investigative Site

    Bron, France

    Active, not recruiting

  • Novartis Investigative Site

    Saint-Herblain, France

    Recruiting

  • Novartis Investigative Site

    Villejuif, France

    Recruiting

  • Novartis Investigative Site

    Milan, MI, Italy

    Active, not recruiting

  • Novartis Investigative Site

    Milan, MI, Italy

    Active, not recruiting

  • Novartis Investigative Site

    Roma, RM, Italy

    Recruiting

  • Novartis Investigative Site

    Kashiwa, Chiba, Japan

    Active, not recruiting

  • Novartis Investigative Site

    Koto Ku, Tokyo, Japan

    Active, not recruiting

  • Novartis Investigative Site

    Kuching, Sarawak, Malaysia

    Active, not recruiting

  • Novartis Investigative Site

    Seoul, South Korea

    Active, not recruiting

  • Novartis Investigative Site

    Pamplona, Navarre, Spain

    Active, not recruiting

  • Novartis Investigative Site

    Barcelona, Spain

    Recruiting

  • Novartis Investigative Site

    Madrid, Spain

    Recruiting

  • Novartis Investigative Site

    Valencia, Spain

    Active, not recruiting

Showing 21 of 21 sites. 7 of the 21 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07468071. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a S | Trialion