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Association details:
| Biomarker: | KRAS G12C |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | opnurasib (JDQ443) (KRAS G12C inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Study of Efficacy and Safety of JDQ443 Single-agent as First-line Treatment for Patients With Locally Advanced or Metastatic KRAS G12C- Mutated Non-small Cell Lung Cancer With a PD-L1 Expression < 1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation.
Excerpt:
...- Presence of a KRAS G12C mutation (all participants) and:...
Trial ID:
Source:
Title:
Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
Excerpt:
...- Participant has a KRAS G12C mutation present in tumor tissue or plasma prior to enrollment, as determined by a Novartis designated central laboratory or by accepted local tests....
Trial ID:
More C2 evidence
Source:
Title:
JDQ443 for KRAS G12C NSCLC Brain Metastases
Excerpt:
...Metastatic (stage IV) NSCLC with the presence of a KRAS G12C mutation (local test, tissue as well as liquid biopsy allowed) and untreated or progressing asymptomatic BM (cohort A) or treated and stable BM (cohort B)....
Trial ID:
Source:
Title:
Study of efficacy and safety of JDQ443 single-agent as first-line treatment for patients with locally advanced or metastatic KRAS G12C- mutated non-small cell lung cancer with a PD-L1 expression =1 % y mutación adicional de STK11.
Excerpt:
...Prior (neo)adjuvant treatment with chemotherapy and/or immunotherapy, or prior radiotherapy administered sequentially or concomitantly with chemotherapy and/or immunotherapy for localized or locally advanced disease are accepted if the time between therapy completion and enrollment is > 12 months.• Presence of a KRAS G12C mutation (all participants) and:• Cohort A: PD-L1 expression < 1%, regardless of STK11 mutation status• Cohort B: PD-L1 expression ≥ 1% and an STK11 co-mutation• At least one measurable lesion per RECIST 1.1.• ECOG performance status ≤ 1.• Participants capable of swallowing study medication. ...
Trial ID:
Source:
Title:
Study of efficacy and safety of JDQ443 in comparison with docetaxel in participants with locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer
Excerpt:
...Presence of a KRAS G12C mutation by central laboratory testing using tissue samples.● Participants have received one prior platinum-based chemotherapy and one prior immune checkpoint inhibitor therapy either in combination or in sequence.● Participants with ECOG performance status from 0 to 2`● Participants are male and female, aged 18 or older. ...
Trial ID:
Less C2 evidence
Source:
Title:
KontRASt-01 update: Safety and efficacy of JDQ443 in KRAS G12C-mutated solid tumors including non-small cell lung cancer (NSCLC).
Published date:
05/25/2023
Excerpt:
Key inclusion criteria: advanced, KRAS G12C-mutated solid tumors...Among response evaluable pts with NSCLC treated in DEs and FE cohorts, the confirmed overall response rate was 41.7% (10/24 pts) across dose levels and 54.5% (6/11 pts) at the RD of 200 mg BID….JDQ443 demonstrates an acceptable safety and tolerability profile at 200 mg BID, with clinical activity in pts with NSCLC.
DOI:
10.1200/JCO.2023.41.16_suppl.9007
Trial ID:
