Non Small Cell Lung Cancer - JDQ443 - KRAS G12C

Association details:

Biomarker:	KRAS G12C
Cancer:	Non Small Cell Lung Cancer
Drug:	opnurasib (JDQ443) (KRAS G12C inhibitor)
Direction:	Sensitive

Evidence:

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrialsregister.eu

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. Estudio de eficacia y seguridad de JDQ443 en monoterapia como tratamiento de primera línea para pacientes con cáncer de pulmón de células no pequeñas localmente avanzado o metastásico KRAS G12C mutado con expresión de PD-L1 <1 % o con expresión de PD-L1 >=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:

2022-001088-29

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

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 histologically confirmed locally advanced/metastatic (stage IIIB/IIIC or IV) * 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:

KontRASt-02

More C2 evidence

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

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:

NCT05445843

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

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:

STRIDER

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrialsregister.eu

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:

2021-002605-10

Evidence Level:

Sensitive: C3 – Early Trials

Source:

ASCO 2023

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:

KontRASt-01