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
- Diseases
- Lung cancer, Colorectal cancer
- 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
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| Vitaz Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Active, not recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Active, not recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Active, not recruiting |
| Centre De Cancerologue Du Grand Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Active, not recruiting |
| Institut De Cancerologie De L Ouest Coordinator of this site? Confirm its status | Saint-Herblain Cedex | France | Active, not recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Active, not recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Kashiwa | Japan | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Koto Ku | Japan | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Kuching | Malaysia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.