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

Study Identifier:
CJDQ443B12105B
CT.gov Identifier:
NCT07468071
EudraCT Identifier:
202552353726
EU Trial (CTIS) Number:
2025-523537-26-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Non-Small Cell Lung Cancer
Solid Tumor
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18 - 100 Years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
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. Key The participant is currently enrolled in a pre-selected Novartis sponsored study and is receiving opnurasib monotherapy or in combination with other investigational treatments.
  • Participants received at least 6 cycles of opnurasib treatment in the parent study.
  • The researchers determined that the participants are currently deriving clinical benefit from the study treatment.
  • 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.
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. Other protocol-defined inclusion/exclusion criteria may apply. Participants permanently discontinued opnurusib treatment in the parent study protocol for any reason other than enrollment in the CJDQ443B12105B study.
  • Participants were unwilling to comply with the contraceptive requirements in the maternal study protocol's Exclusion criteria.
  • The participant currently has unrecovered toxicity, therefore opnurasib administration was discontinued in the parent study.
  • 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.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Ramon Yarza
Status
Recruiting
Condition(s) Treated at Site
Non-Small Cell Lung Cancer
Solid Tumor