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:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT06607393
Eligibility Criteria:
Inclusion Criteria:
* Non-small cell lung cancer (NSCLC) diagnosis
* Histology not indicative of squamous cell carcinoma
* Metastatic disease
* Epidermal growth factor receptor (EGFR) and Anaplastic lymphoma kinase (ALK)-negative or Kirsten rat sarcoma viral oncogene homolog (KRAS)-positive
* No prior systemic treatment for metastatic NSCLC
* No record of adjuvant or neoadjuvant therapy in the 12 months before metastatic diagnosis
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or missing or Karnofsky performance status \>=70 or missing
* No lab results indicating inadequate organ function, as defined in the KEYNOTE-189 RCT protocol
Exclusion Criteria:
* Histology indicative of squamous cell carcinoma or small cell elements
* Prior systemic treatment for metastatic NSCLC
* Prior antineoplastic biological therapy
* History of major cancer-related surgery in the 3 weeks before study drug initiation
* Radiation therapy to the lung \>30 Gy in the 6 months before study drug initiation
* Prior diagnosis of clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction
* Diagnosis of a second primary malignant neoplasm
* Diagnosis of brain, central nervous system, and/or spinal cord metastases
* Diagnosis of autoimmune disease and treatment with corticosteroids or immunosuppressive drugs after diagnosis and within the 2 years prior to study drug initiation
* Treatment with a non-topical systemic steroid in each of the 6 months prior to study drug initiation
* Prior treatment with pembrolizumab or any other anti-PD-1, PD-L1, PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms
* Treatment with non-topical antibiotics, antifungals, or antivirals within 2 weeks after an infection diagnosis in the month prior to study drug initiation
* Diagnosis of human immunodeficiency virus infection
* Diagnosis of acute hepatitis B or C
* Diagnosis of ascites or plural effusion in the 3 months prior to study drug initiation
* Prior diagnosis of interstitial lung disease or diagnosis of pneumonitis and record of treatment with glucocorticoids within 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06607393
Study Brief:
Protocol Section:
NCT06607393