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)

September 3, 2026 updated by: Novartis Pharmaceuticals

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Screening occurs on the same day as the parent study's End of Treatment visit, with informed consent and eligibility confirmation required before enrollment. Eligible participants start treatment within seven days and return for scheduled visits for drug resupply, safety monitoring, and confirmation of clinical benefit. Sites are expected to follow their local practice regarding the method and frequency of the assessments used to assess clinical benefit for the patient. Treatment continues until disease progression or other discontinuation criteria, and safety follow-up lasts 30-150 days depending on the last drug received. The study will remain open for up to three years from first participant visit or until all participants discontinue.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • Novartis Investigative Site
    • Oost Vlaanderen
      • Sint-Niklaas, Oost Vlaanderen, Belgium, 9100
        • Active, not recruiting
        • Novartis Investigative Site
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • Novartis Investigative Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • Novartis Investigative Site
  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Active, not recruiting
        • Novartis Investigative Site
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Novartis Investigative Site
  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Novartis Investigative Site
  • France
      • Bron, France, 69677
        • Recruiting
        • Novartis Investigative Site
  • Italy
    • MI
      • Milan, MI, Italy, 20133
        • Recruiting
        • Novartis Investigative Site
      • Milan, MI, Italy, 20162
        • Recruiting
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00128
        • Recruiting
        • Novartis Investigative Site
  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan, 2778577
        • Active, not recruiting
        • Novartis Investigative Site
    • Tokyo
      • Koto Ku, Tokyo, Japan, 1358550
        • Active, not recruiting
        • Novartis Investigative Site
  • Malaysia
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Active, not recruiting
        • Novartis Investigative Site
  • South Korea
      • Seoul, South Korea, 03080
        • Active, not recruiting
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Novartis Investigative Site
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Active, not recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: opnurasib single agent
Eligible participants will receive the same starting dose and regimen of opnurasib as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
Drug: Opnurasib
Eligible participants will receive the same starting dose and regimen of opnurasib as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
Other Names:
  • JDQ443
Experimental: Group 2: opnurasib + TNO155
Eligible participants will receive the same starting dose and regimen of opnurasib and any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
Drug: Opnurasib
Eligible participants will receive the same starting dose and regimen of opnurasib as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
Other Names:
  • JDQ443
Drug: TNO155
Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
Experimental: Group 3: opnurasib + trametinib
Eligible participants will receive the same starting dose and regimen of opnurasib and any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
Drug: Opnurasib
Eligible participants will receive the same starting dose and regimen of opnurasib as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
Other Names:
  • JDQ443
Drug: trametinib
Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
Other Names:
  • TMT212
Experimental: Group 4: opnurasib + cetuximab
Eligible participants will receive the same starting dose and regimen of opnurasib and any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
Drug: Opnurasib
Eligible participants will receive the same starting dose and regimen of opnurasib as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
Other Names:
  • JDQ443
Biological: cetuximab
Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
Experimental: Group 5: opnurasib + tislelizumab
Eligible participants will receive the same starting dose and regimen of opnurasib and any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
Drug: Opnurasib
Eligible participants will receive the same starting dose and regimen of opnurasib as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
Other Names:
  • JDQ443
Biological: tislelizumab
Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
Other Names:
  • VDT482

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants receiving opnurasib as single agent or in combination with other study treatments
Time Frame: Assessed up to approximately 3 years
The number of participants enrolled and receiving opnurasib as single agent or in combination with other study treatments under the rollover study, will be summarized by treatment arm.
Assessed up to approximately 3 years
Duration of exposure to study treatment
Time Frame: Assessed up to approximately 3 years
The duration of exposure in months to opnurasib and the combination partner will be summarized by means of descriptive statistics using the SAS.
Assessed up to approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of Adverse Events (AEs)
Time Frame: Assessed up to approximately 3 years

The distribution of adverse events will be evaluated by analyzing the frequencies of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs).

In this study, TEAEs are defined as AEs with an onset date after the start of the treatment period, or events that were present before the treatment period but subsequently increased in severity, changed from not suspected to suspected of being related to study treatment, or evolved into SAEs after the start of the treatment period.

The safety follow-up period will extend from the first administration of study treatment until:

  1. 30 days after the last dose for participants receiving opnurasib as monotherapy or in combination with TNO155 or trametinib,
  2. 60 days after the last dose for participants receiving opnurasib in combination with cetuximab, and
  3. 150 days after the last dose for participants receiving opnurasib in combination with tislelizumab.
Assessed up to approximately 3 years
Number of participants with dose adjustments
Time Frame: Assessed up to approximately 3 years
The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by treatment arm.
Assessed up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2026

Primary Completion (Estimated)

June 11, 2029

Study Completion (Estimated)

September 11, 2029

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CJDQ443B12105B
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523537-26-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe