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

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 - CJDQ443B12105B

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031260238

Enrollment

Registered

2026-06-22

Start date

2026-06-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced or Metastatic KRAS G12C NSCLC Advanced Solid Tumors with KRAS G12C

Interventions

opnurasib single agent

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

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

Countries

Belgium, Canada, China, Denmark, France, Germany, Italy, Japan, Korea, Malaysia, Netherlamds, Spain

Contacts

Public ContactKyosuke Yamauchi

Novartis Pharma. K.K.

rinshoshiken.toroku2@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026