A Real-world Study of Durvalumab for Lung Cancer in China

Sponsor
Peking Union Medical College Hospital
Study ID
NCT04672759
Status
Unknown

Conditions

  • Non Small Cell Lung Cancer Stage III
  • Small-Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Patients receive durvalumab as an intravenous infusion over 60 minutes on day 1. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
  • Durvalumab — DRUG
    Durvalumab monotherapy or combined with chemotherapy and/or radiotherapy.

Study Details

PACIFIC-PUMCH-R is an ambispective cohort study that will enroll approximately 100 patients with lung cancer who have received at least one dose of durvalumab between July 2020 and July 2021. Patient selection and data collection will be from Peking Union Medical College Hospital. Cohort 1 will include patients with unresectable stage III non-small cell lung cancer (according to the Staging Manual in Thoracic Oncology, version 7, of the International Association for the Study of Lung Cancer) who did not have disease progression after concurrent chemoradiotherapy. The primary objective of Cohort 1 is to assess the effectiveness of durvalumab in a real-life setting by evaluating PFS and OS in Chinese patients. Cohort 2 will enroll patients with histologically or cytologically confirmed NSCLC or SCLC who have received chemotherapy/radiotherapy at the physician's discretion. And this Cohort aimed to assess the safety of durvalumab for the treatment of lung cancer in clinical practice.

Key Dates

Start date
Jul 28, 2020
Status verified
Dec 2020
Primary completion
Jun 30, 2021
Completion
Oct 31, 2024

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Cohort 1
    Cohort 1 will include patients with unresectable stage III non-small cell lung cancer. Patients receive durvalumab as an intravenous infusion over 60 minutes on day 1. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
  • Arm: Cohort 2
    Cohort 2 will enroll patients with histologically or cytologically confirmed NSCLC or SCLC who will or have received chemotherapy/radiotherapy at the physician's discretion.

Primary Outcome Measure

Progression-free Survival (Cohort 1) [ Time Frame: Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years ]

Central Contacts

Related Studies