None listed
Conditions
Interventions
None listed
Sponsors
Pusan National University Yangsan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Individuals who have received a full explanation of this clinical study, understood the information provided, voluntarily decided to participate, and provided written informed consent 2) Adult patients aged 19 years or older 3) Patients with histologically or cytologically confirmed stage IV nonsquamous non-small cell lung cancer (NSCLC) without EGFR or ALK mutations 4) Patients with no prior systemic anticancer therapy ? However, patients who experienced recurrence more than 6 months after completing prior neoadjuvant/adjuvant chemotherapy or definitive chemoradiotherapy may be eligible. But, patients who failed durvalumab as maintenance therapy are excluded 5) Patients scheduled to receive first-line treatment with pembrolizumab in combination with pemetrexed and platinum 6) Patients with at least one measurable lesion based on RECIST version 1.1
Exclusion criteria
Exclusion criteria: 1) Patients who are currently receiving or have completed first-line treatment with pembrolizumab in combination with pemetrexed and platinum 2) Patients with untreated active brain metastases and/or carcinomatous meningitis ? However, enrollment is permitted under the following conditions: ? Patients with stable brain metastases who are asymptomatic and show no neurological signs or symptoms after appropriate local therapy prior to enrollment. ? Patients with asymptomatic brain metastases. 3) Patients who received radiotherapy to the primary lesion within 1 month prior to the first dose. 4) Patients with an active autoimmune disease requiring systemic treatment within the past 2 years. 5) Patients who received systemic corticosteroids or other immunosuppressive therapy within 2 weeks prior to the first dose ? However, enrollment is permitted under the following conditions: ? Patients on low-dose corticosteroids (=10 mg/day of prednisone or equivalent for =7 consecutive days) may be enrolled at the investigator's discretion ? Inhaled corticosteroids are permitted 6) Patients whose medical records are not accessible for review
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year Real-world Progression Free Survival rate, 1yr rwPFS rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Real-world Progression Free Survival, rwPFS;real-world Overall survival, rwOS;real-world Objective response rate, rwORR;real-world Duration of response, rwDoR;Safety profile | — |
Countries
Korea, Republic of
Contacts
Public ContactSeong Hoon Yoon
Pusan National University Yangsan Hospital
Outcome results
None listed