For Healthcare Professionals

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.


About the study

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).

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Key Inclusion criteria

  1. 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.
  2. Presence of a KRAS G12C mutation (all participants) and:
  3. Cohort A: PD-L1 expression < 1%, regardless of STK11 mutation status
  4. Cohort B: PD-L1 expression ≥ 1% and an STK11 co-mutation
  5. At least one measurable lesion per RECIST 1.1.
  6. ECOG performance status ≤ 1.
  7. Participants capable of swallowing study medication.


Key Exclusion criteria

  1. 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
  2. Previous use of a KRAS G12C inhibitor or previous systemic treatment for metastatic NSCLC.
  3. A medical condition that results in increased photosensitivity (i.e. solar urticaria, lupus erythematosus, etc).
  4. Know active (unstable/symptomatic) central nervous system (CNS) metastases and/or carcinomatous meningitis
  5. 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

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-888-669-6682Email iconEmail Study Center

Study’s details


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

Age (in years)



Phase 2

Participants needed


Est. Completion Date

Nov 30, 2027

Treatment type



Novartis identifier


Study number


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