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Clinical Trials in Spain / NCT07468071
Active, not recruiting Phase 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

NCT07468071 · tracked via the Priya Life Science Spain tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 1/2
Started
2026-06-08
Last updated
2026-10-09

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Opnurasib →TNO155 →trametinib →cetuximab →tislelizumab →

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.

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.

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.

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.

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of participants receiving opnurasib as single agent or in combination with other study treatments — 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.
  • Duration of exposure to study treatment — 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.

Trial sites (21)

FacilityCityRegionStatus
Novartis Investigative Site Sint-Niklaas Oost Vlaanderen
Novartis Investigative Site Leuven Belgium
Novartis Investigative Site Montreal Quebec
Novartis Investigative Site Sherbrooke Quebec
Novartis Investigative Site Guangzhou Guangdong
Novartis Investigative Site Changsha Hunan
Novartis Investigative Site Copenhagen Denmark
Novartis Investigative Site Bron France
Novartis Investigative Site Saint-Herblain France
Novartis Investigative Site Villejuif France
Novartis Investigative Site Milan MI
Novartis Investigative Site Milan MI
Novartis Investigative Site Roma RM
Novartis Investigative Site Kashiwa Chiba
Novartis Investigative Site Koto Ku Tokyo
Novartis Investigative Site Kuching Sarawak
Novartis Investigative Site Seoul South Korea
Novartis Investigative Site Pamplona Navarre
Novartis Investigative Site Barcelona Spain
Novartis Investigative Site Madrid Spain
Novartis Investigative Site Valencia Spain

More Novartis Pharmaceuticals trials in Spain

Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease Active, not recruiting
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor. Active, not recruiting
An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Active, not recruiting
A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS) Active, not recruiting
Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07468071 on ClinicalTrials.gov ↗ ← All trials in Spain