NCT07468071

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
40mo left

Started Jun 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Jun 2026Sep 2029

First Submitted

Initial submission to the registry

March 9, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 8, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2029

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

March 9, 2026

Last Update Submit

June 9, 2026

Conditions

Advanced Solid Tumors Harboring the KRAS G12C MutationLocally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer

Keywords

KRAS G12Cnon-small cell lung cancer (NSCLC)colorectal cancer (CRC)advanced solid tumorsopnurasib (JDQ443)TNO155trametinib (TMT212)cetuximabtislelizumab (VDT482)

Outcome Measures

Primary Outcomes (2)

  • Number of participants receiving opnurasib as single agent or in combination with other study treatments

    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

    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 Outcomes (2)

  • Incidence rate of Adverse Events (AEs)

    Assessed up to approximately 3 years

  • Number of participants with dose adjustments

    Assessed up to approximately 3 years

Study Arms (5)

Group 1: opnurasib single agent

EXPERIMENTAL

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

Group 2: opnurasib + TNO155

EXPERIMENTAL

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: OpnurasibDrug: TNO155

Group 3: opnurasib + trametinib

EXPERIMENTAL

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: OpnurasibDrug: trametinib

Group 4: opnurasib + cetuximab

EXPERIMENTAL

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: OpnurasibBiological: cetuximab

Group 5: opnurasib + tislelizumab

EXPERIMENTAL

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: OpnurasibBiological: tislelizumab

Interventions

OpnurasibDRUG

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.

Also known as: JDQ443
Group 1: opnurasib single agentGroup 2: opnurasib + TNO155Group 3: opnurasib + trametinibGroup 4: opnurasib + cetuximabGroup 5: opnurasib + tislelizumab
TNO155DRUG

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.

Group 2: opnurasib + TNO155
trametinibDRUG

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.

Also known as: TMT212
Group 3: opnurasib + trametinib
cetuximabBIOLOGICAL

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.

Group 4: opnurasib + cetuximab
tislelizumabBIOLOGICAL

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.

Also known as: VDT482
Group 5: opnurasib + tislelizumab

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Participant has been permanently discontinued from opnurasib in the parent protocol for any reason other than enrollment in the CJDQ443B12105B study.
  • Participant currently has unresolved toxicities for which opnurasib dosing has been interrupted in the parent study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungColorectal Neoplasms

Interventions

JDQ443trametinibCetuximabtislelizumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+81337978748novartis.email@novartis.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 12, 2026

Study Start

June 8, 2026

Primary Completion (Estimated)

June 15, 2029

Study Completion (Estimated)

September 17, 2029

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

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

Locations

KR(1)