Abstract 726TiP
Background
Lung cancer is the most common cancer and leading cause of cancer death in China. However, uneven diagnosis and treatment levels, and inadequate implementation of guidelines exist. PCCM Department plays an important role in lung cancer care. This study is to determine whether lung cancer clinical care Quality Improvement Project (QIP) could significantly improve guideline adoption and clinical outcomes of lung cancer.
Trial design
This is a cluster randomized controlled trial with PCCM Department in each site being the cluster. 54 sites with qualified PCCM Departments will be randomized to the QIP arm versus control arm in 2:1 ratio. The QIP arm will perform QIP intervention, including quality improvement workshop, medical education course, coaching expert onsite coach, e.g., clinical ward rounds, multi-disciplinary team (MDT) discussion. The control arm will follow current clinical care. Approximately 1728 non-small cell lung cancer(NSCLC) or extensive-stage small-cell lung cancer (ES-SCLC) patients, without prior systematic anti-tumor therapy or recurrent disease ≥12 month after adjuvant or neo-adjuvant therapy, ECOG PS 0-2, will be prospectively enrolled. Patients in the QIP arm will be enrolled after about 3-month QIP intervention. Patients in the control arm will be enrolled once the trial initiation. Patients will be followed up to 30 months. The primary endpoints include molecular testing rate of NSCLC prior to the first systematic anti-tumor therapy and adjuvant or first line targeted therapy treatment rate in actional gene alterations (AGAs) NSCLC. The secondary endpoints include clinical staging rate, spirometry rate, biopsy methods, first line immunotherapy treatment rate in unresectable non-AGA NSCLC, first line chemo-immunotherapy treatment rate of ES-SCLC (stage III-IV), surgical rate of stage I-IIIA NSCLC, MDT rate of stage IIIB-IV NSCLC, objective response rate, progression-free survival of stage IIIB-IV NSCLC and ES-SCLC and disease-free survival of NSCLC who receive neoadjuvant/adjuvant therapy. This study is funded by AstraZeneca Investment (China) Co, LTD.
Clinical trial identification
Legal entity responsible for the study
AstraZeneca Investment (China) Co., Ltd.
Funding
AstraZeneca Investment (China) Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.