START: Real-world study on sequential therapy with afatinib as first-line treatment in patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44236
• EU PAS number:
  EUPAS32423
• Study ID:
  44236
• Official title and acronym:
  START: Real-world study on sequential therapy with afatinib as first-line treatment in patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC)
• DARWIN EU® study:
  No
• Study countries:
  China
• Study description:
  The START study observes afatinib as first-line treatment and sequential therapy in patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer。
• Study status:
  Ongoing

Research institutions and networks

Institutions

Zhejiang University

The First Affiliated Hospital,College of Medicine

Peking Union Medical College Hospital

West China Hospital

Guangdong Provincial People's Hospital China, Hunan Cancer Hospital China, Hainan Cancer Hospital China, Peking Union Medical College China, West China Hospital, Sichuan University China, The first affiliated hospital of Zhengzhou University China, Shandong Cancer Hospital China, Yunnan Cancer Hospital China, Peking University Third Hospital China, Shenyang Tenth People‘s Hospital China

Study timelines

Date when funding contract was signed

Planned: 29/03/2019

Actual: 28/03/2019

Study start date

Planned: 29/05/2020

Actual: 20/05/2020

Data analysis start date

Planned: 15/02/2026

Date of interim report, if expected

Planned: 31/03/2024

Date of final study report

Planned: 30/04/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim China Investment Co., Ltd.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable