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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.
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.

NCT05445843

Active Not RecruitingPhase 2

Sponsor: Novartis Pharmaceuticals

Conditions: 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

Interventions: JDQ443

Countries: United States, Argentina, Austria, Belgium, Brazil, China, France, Germany

This study aims to evaluate 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 have a PD-L1 expression \< 1% (cohort A) or a PD-L1 expression ≥ 1% and an STK11 co-mutation (cohort B).

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (45)
  • Providence, Rhode Island, United States
  • Pilar, Buenos Aires, Argentina
  • Córdoba, Córdoba Province, Argentina
  • Buenos Aires, Argentina
  • Córdoba, Argentina
  • Feldkirch, Austria
  • Wels, Austria
  • Sint-Niklaas, Oost Vlaanderen, Belgium
  • Roeselare, West-Vlaanderen, Belgium
  • Salvador, Estado de Bahia, Brazil
  • Belo Horizonte, Brazil
  • Rio de Janeiro, Brazil
  • Wuhan, Hubei, China
  • Changsha, Hunan, China
  • Beijing, China
  • Marseille, Bouches Du Rhone, France
  • Bron, France
  • Montpellier, France
  • Saint-Herblain, France
  • Strasbourg, France
  • Kempten (Allgäu), Bavaria, Germany
  • Halle, Saxony-Anhalt, Germany
  • Hamburg, Germany
  • Oldenburg, Germany
  • Tübingen, Germany
  • Athens, Greece
  • Mátraháza, Hungary
  • Thellakom Kottayam, Kerala, India
  • Varanasi, Uttar Pradesh, India
  • Bari, BA, Italy
  • + 15 more on CT.gov