ChemoRadiotherapy with Or Without surgery followed by consolidation Durvalumab (CROWD): a phase IV feasibility trial

Phase 1

Conditions: Stage III non-small cell lung cancer
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2024-511711-21-00

Lead Sponsor: Amsterdam UMC Stichting

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 38

Inclusion Criteria

Histologically or cytologically confirmed stage III (non-N3) NSCLC (TNM 8th edition), before start of chemoradiotherapy, 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., Initial MDT recommendation for a non-surgical treatment comprising CRT followed by durvalumab

Exclusion Criteria

Patients with TxN3 or M1 disease, The use of any CRT schemes other than those in ESMO recommendations (platinum doublet, 30 once-daily fractions of 2 Gy), Patients deemed inoperable based on cardiopulmonary function tests or comorbidity

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: -to assess the feasibility of surgery within 12 weeks after high-dose chemoradiotherapy in stage III NSCLC<br>-to assess the ability to proceed to durvalumab consolidation therapy after surgery;Secondary Objective: To assess 90-day postoperative morbidity, mortality, and treatment related toxicity, To assess disease free survival (DFS) at 2 years;Primary end point(s): Feasibility of conducting surgical resections in stage III patients within 12 weeks after high-dose chemoradiotherapy, Number of patients able to proceed to durvalumab consolidation after surgery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Severe surgical morbidity and mortality (Clavien-Dindo grade 3-5), treatment related toxicity (Gr III-V) within 90-days of surgery;Secondary end point(s):DFS in 2 years, defined from the day of surgery