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.

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.

ClinicalTrials.gov Identifier: NCT05445843

Novartis Reference Number: CJDQ443B12201

Last Update: Dec 20, 2022

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

This study aims to assess the antitumor activity and safety of JDQ443 single-agent as first-line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor a KRAS G12C mutation and a PD-L1 expression < 1% regardless of STK11 mutation status (cohort A), or a PD-L1 expression ≥ 1% and an STK11 co-mutation (cohort B).

Condition

Locally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation

Phase

Phase 2

Overall status

Recruiting

Start date

Dec 06, 2022

Completion date

Nov 30, 2027

Gender

All

Age(s)

18 Years and older (Adult, Older Adult)

Interventions

Drug

JDQ443

JDQ443 orally administered

Eligibility Criteria

Key Inclusion criteria

Histologically confirmed locally advanced (stage IIIb/IIIc not eligible for definitive chemoradiation or surgical resection with curative intent) or metastatic (stage IV) NSCLC without previous systemic treatment for metastatic disease. 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.

Key Exclusion criteria

Participants whose tumors harbor an EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing. Participants with other known druggable alterations will be excluded, if required by local guidelines
Previous use of a KRAS G12C inhibitor or previous systemic treatment for metastatic NSCLC.
A medical condition that results in increased photosensitivity (i.e. solar urticaria, lupus erythematosus, etc).
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Participants who are taking a prohibited medication (strong CYP3A inducers) that cannot be discontinued at least seven days prior to the first dose of study treatment and for the duration of the study

Other inclusion/exclusion criteria may apply