durvalumab for Stage III non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Histologically or cytologically confirmed stage III (non-N3) NSCLC (TNM 8th edition), before start of chemoradiotherapy\n- In case of suspected N2-disease, mediastinal invasive staging (EUS, EBUS and/or mediastinoscopy) to prove N2 involvement before start of concurrent CRT is mandatory.\n- Initial MDT recommendation for a non-surgical treatment comprising CRT followed by durvalumab"}

Exclusion criteria

• {"criterion_text":"- Patients with TxN3 or M1 disease\n- The use of any CRT schemes other than those in ESMO recommendations (platinum doublet, 30 once-daily fractions of 2 Gy)\n- Patients deemed inoperable based on cardiopulmonary function tests or comorbidity\n- Patients with known actionable genomic alterations."}

Primary endpoints

• {"endpoint_text":"- Safety defined as the rates of severe surgical morbidity and mortality (Clavien-Dindo grade 3-5) and the percentage of patients with treatment-related adverse events (Gr III-V) within 90-days of surgery","definition_or_measurement_approach":"Rates of severe surgical morbidity and mortality (Clavien-Dindo grade 3-5) and percentage of patients with treatment-related adverse events (Grade III-V) assessed within 90 days after surgery."}
• {"endpoint_text":"- Number of patients able to proceed to durvalumab consolidation after surgery","definition_or_measurement_approach":"Count of patients who are able to start durvalumab consolidation therapy following surgery."}

Secondary endpoints

• {"endpoint_text":"- Rate of complete surgical resection (R0)","definition_or_measurement_approach":"Proportion of patients achieving complete (R0) surgical resection."}
• {"endpoint_text":"- DFS in 2 years, defined from the day of surgery","definition_or_measurement_approach":"Disease-free survival at 2 years, measured from the day of surgery."}

Netherlands

Earliest CTIS Part Ii Submission Date

17-05-2024

Latest Decision Or Authorization Date

12-12-2024

Processing Time Days

209

Number Of Sites

1

Number Of Participants

38

Primary sponsor

Full Name

Amsterdam UMC Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands