Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2025-12-24 @ 2:00 PM
NCT ID:
NCT04933695
Eligibility Criteria:
Inclusion Criteria:
* Adult (= or \> 18 years old) with NSCLC
* Untreated Stage IV metastatic disease. Participants who received adjuvant or neoadjuvant anti-tumor therapy are eligible if the adjuvant/neoadjuvant therapy was completed greater than 12 months prior to the development of metastatic stage IV disease
* Pathologically documented metastatic NSCLC with KRAS G12C mutation (local confirmation)
* Programmed death-ligand 1 (PD-L1) TPS Score \< 1% and/or serine/threonine kinase 11 (STK11) co-mutation (local confirmation)
* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
* No active brain metastases
* Measurable disease per investigator interpretation using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Exclusion Criteria:
* Mixed small-cell lung cancer and NSCLC histology
* Myocardial Infarction within 6 months of study Day 1
* Use of proton-pump inhibitors (PPIs), histamine (H2) receptor antagonists (H2RA), strong inducers of cytochrome P450 (CYP) 3A4 (CYP3A4) or known CYP3A4 sensitive substrates or P-gp substrates
* Therapeutic or palliative radiation therapy within 2 weeks of study day 1
* Unable to take oral medication
* Unable to receive both iodinated contrast for computed tomography (CT) scans and gadolinium contrast for magnetic resonance imagine (MRI) scans
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04933695
Study Brief:
Protocol Section:
NCT04933695