Study of efficacy and safety of JDQ443 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-mutatio

Phase 2

• Conditions: Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

• Registration Number: CTRI/2024/01/061436
• Lead Sponsor: ovartis Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1 Participant is an adult = 18 years of age at the time of informed consent.

2 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.

3 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

4 At least one measurable lesion per RECIST 1.1.

ECOG performance status = 1.

5 Participants capable of swallowing study medication.

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).

Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

4 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified