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NCT07468071Active, not recruitingPhase 1/2

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

Source: ClinicalTrials.gov · Last updated 23 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
25 (actual)
First submitted
9 Mar 2026
Start date
8 Jun 2026
Primary completion date
11 Jun 2029
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT07468071
EU CT number
2025-523537-26-00

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 25
  • From 8 Jun 2026 to the primary completion date, 11 Jun 2029
  • 24 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UZ Leuven
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LeuvenBelgiumActive, not recruiting
Vitaz
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Sint-NiklaasBelgiumActive, not recruiting
Novartis Investigative Site
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MontrealCanadaUnknown status
Novartis Investigative Site
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SherbrookeCanadaUnknown status
Novartis Investigative Site
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ChangshaChinaUnknown status
Novartis Investigative Site
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GuangzhouChinaUnknown status
Rigshospitalet
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Copenhagen OeDenmarkActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario HM Sanchinarro
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MadridSpainActive, not recruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainActive, not recruiting
Hospital Universitario de Navarra
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PamplonaSpainActive, not recruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainActive, not recruiting
Hospices Civils de Lyon
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BronFranceActive, not recruiting
Centre Leon Berard
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LyonFranceActive, not recruiting
Centre De Cancerologue Du Grand Montpellier
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MontpellierFranceActive, not recruiting
Institut De Cancerologie De L Ouest
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Saint-Herblain CedexFranceActive, not recruiting
Institut Gustave Roussy
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VillejuifFranceActive, not recruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyActive, not recruiting
Istituto Nazionale dei Tumori
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MilanItalyActive, not recruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyActive, not recruiting
Novartis Investigative Site
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KashiwaJapanUnknown status
Novartis Investigative Site
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Koto KuJapanUnknown status
Novartis Investigative Site
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SeoulSouth KoreaUnknown status
Novartis Investigative Site
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KuchingMalaysiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.