Evidence Level:Sensitive: C2 – Inclusion Criteria
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....
Evidence Level:Sensitive: C2 – Inclusion Criteria
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)....
More C2 evidence
Evidence Level:Sensitive: C2 – Inclusion Criteria
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:...
Evidence Level:Sensitive: C2 – Inclusion Criteria
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. ...
Evidence Level:Sensitive: C2 – Inclusion Criteria
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. ...
Less C2 evidence
Evidence Level:Sensitive: C3 – Early Trials
Title:
KontRASt-01 update: Safety and efficacy of JDQ443 in KRAS G12C-mutated solid tumors including non-small cell lung cancer (NSCLC).
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