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New treatment option for Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung...
Official title 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
ClinicalTrials.gov ID: NCT07468071
What this study is testing
What is Opnurasib?
Opnurasib is an investigational medicine, being studied as a potential treatment for locally advanced or metastatic kras g12c-mutated non-small cell lung cancer.
Also referred to as JDQ443.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Participant is currently enrolled in a pre-defined Novartis-sponsored study and is receiving opnurasib as single agent or in combination with other...
- 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...
You likely can't join if
- 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 study team makes the final eligibility decision.
Where it's taking place
- Sint-Niklaas, Oost Vlaanderen, Belgium
- Montreal, Quebec, Canada
- Guangzhou, Guangdong, China
- Kashiwa, Chiba, Japan
- Koto Ku, Tokyo, Japan
- Kuching, Sarawak, Malaysia
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sint-Niklaas, Oost Vlaanderen, Belgium; Montreal, Quebec, Canada; Guangzhou, Guangdong, China; Kashiwa, Chiba, Japan; Koto Ku, Tokyo, Japan; Kuching, Sarawak, Malaysia and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.