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JDQ443

DRUG13 trials

Sponsors

University Hospital Maastricht, Novartis Pharma AG, Novartis Pharmaceuticals, Canadian Cancer Trials Group, Maastricht University Medical Center

Conditions

Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumorsAdvance solid tumors harboring the KRAS G12C mutationAdvanced non-small cell lung cancer harboring the KRAS G12C mutationBrain Metastases, AdultCancer of LungCancer of the LungCarcinoma, ColorectalCarcinoma, Non-Small Cell Lung

Phase 1

Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
Active, not recruitingNCT04699188
Novartis PharmaceuticalsCancer of Lung, Cancer of the Lung, Carcinoma, Colorectal +7
Start: 2021-02-24End: 2027-01-25Updated: 2026-03-18
A Phase 1 Study to Evaluate the Pharmacokinetics of JDQ443 in Participants With Hepatic Impairment Compared to Matched Healthy Control Participants.
CompletedNCT05329623
Novartis PharmaceuticalsSmall Cell Lung Carcinoma
Start: 2022-05-03End: 2024-04-07Updated: 2025-10-10
Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
Active, not recruitingNCT05358249
Novartis PharmaceuticalsCarcinoma, Non-Small Cell Lung, Carcinoma, Non-Small-Cell Lung, Colorectal Cancer +8
Start: 2022-10-24End: 2026-09-30Updated: 2026-06-15
KontRASt-03: A Phase Ib/II, multicenter, open-label platform study of JDQ443 with select combinations in patients with advanced solid tumors harboring the KRAS G12C mutation
RecruitingCTIS2023-506716-41-00
Novartis Pharma AGAdult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors
Start: 2023-05-08Target: 200Updated: 2026-01-19
A phase Ib/II open-label, multi-center dose escalation study of JDQ443 in patients with advanced solid tumors harboring the KRAS G12C mutation
Active, not recruitingCTIS2023-508073-87-00
Novartis Pharma AGAdvance solid tumors harboring the KRAS G12C mutation
Start: 2024-11-14Target: 359Updated: 2026-01-16
KontRASt-R: An open-label, multi-center, rollover study for participants who have been previously enrolled into a Novartis-sponsored opnurasib (JDQ443) study and are continuing to benefit from opnurasib as a single agent or in combination with other study treatments
Not yet recruitingCTIS2025-523537-26-00
Novartis Pharma AGLocally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer; advanced solid tumors harboring the KRAS G12C mutation.
Target: 16Updated: 2026-06-09

Phase 2

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.
Active, not recruitingNCT05445843
Novartis PharmaceuticalsLocally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation
Start: 2022-12-06End: 2026-12-31Updated: 2026-07-02
Neoadjuvant Platform Trial in Non-Small Cell Lung Cancer
Active, not recruitingNCT05714891
Canadian Cancer Trials GroupNSCLC
Start: 2023-09-15End: 2028-03-31Updated: 2026-02-12
JDQ443 for KRAS G12C NSCLC Brain Metastases
WithdrawnNCT05999357
Maastricht University Medical CenterBrain Metastases, Adult, KRAS G12C, Non Small Cell Lung Cancer Metastatic
Start: 2024-04-15End: 2028-08-31Updated: 2024-05-29
STRIDER: A phase II Study evaluaTing intRacranial effIcacy of JDQ443 in patiEnts with KRAS G12C+ NSCLC and bRain metastases
CompletedCTIS2023-505721-13-00
University Hospital Maastrichtpatients with KRAS G12C+ non small cell lung cancer and brain metastases
End: 2024-06-10Target: 42Updated: 2023-11-20
KontRASt-06: An open-label phase II trial evaluating the activity 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.
SuspendedCTIS2024-511708-18-00
Novartis Pharma AGLocally 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.
Start: 2022-12-06Target: 57Updated: 2025-08-13

Phase 3

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