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

NCT04672759 | Unknown

• 1 other identifier: PACIFIC-PUMCH-R
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Progression-free Survival (Cohort 1)

  PFS is defined as time from the index date (date of the first dose of durvalumab) to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD.

  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

• Overall Survival (Cohort 1)

  OS is defined as the time from randomization to the time of death from any cause.

  From baseline until death due to any cause. Assessed up to a maximum of approximately 4 years.

• Number of Participants With one or more Adverse Events (Cohort 2)

  Adverse events (AE) are graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

  Baseline until up to 90 days after end of treatment.

Secondary Outcomes (9)

• Objective response rate (Cohort 1)

  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 4 years.

• Duration of Response (Cohort 1)

  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 4 years.

• Time to death or distant metastasis (Cohort 1)

  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 4 years.

• Time from the index date to second progression (Cohort 1)

  Following confirmed progression, patients were assessed every ~12 weeks until second disease progression. Assessed up to a maximum of approximately 4 years.

• Number of Participants With one or more Adverse Events (Cohort 1)

  Baseline until up to 90 days after end of treatment.

Study Arms (2)

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.

Drug: Durvalumab

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.

Drug: Durvalumab

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.

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will enroll approximately 100 patients with lung cancer who have received at least one dose of durvalumab between July 2020 and July 2022. Patient selection and data collection will be from Peking Union Medical College Hospital.

You may qualify if:

• Patient capable of proper therapeutic compliance, and accessible to correct follow-up.
• Written Informed Consent (IC) for trial treatment must be signed and dated by the patient and the investigator prior to any trial-related evaluation and/or intervention.
• Age ≥ 18 years at time of study entry or adult according to each country regulations for age of majority.
• Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent, unresectable (stage III) disease (according to American Joint Committee on Cancer \[AJCC\] lung cancer edition 8). Histologically or cytologically documented extensive disease (American Joint Committee on Cancer Stage (8th edition) IV SCLC. Brain MRI or high-quality brain CT with intravenous contrast at the time of staging mandatory is strongly recommended.
• Patients who received definitive concurrent chemoradiation therapy and have not progressed were enrolled in the Cohort 1. Patients who received chemotherapy, radiotherapy or sequential chemotherapy were enrolled in the Cohort 2.
• Tumour sample requirements: Provision of an unstained tumor samples in a quantity sufficient to allow for analysis (≤3 months newly collected sample is preferred, ≤6 months archival sample is also accepted.)
• No prior exposure to immune-mediated therapy including, but not limited to, other.
• anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2.
• (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.

You may not qualify if:

• History of allogenic organ transplantation.
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis with the exception of diverticulosis, systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, and uveitis, etc\]). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia
• Patients with hypothyroidism (eg, following Hashimoto syndrome) and stable
• on hormone replacement
• Any chronic skin condition that does not require systemic therapy
• Patients without active disease in the last 5 years may be included but only after
• consultation with the Study Physician
• Patients with celiac disease controlled by diet alone
• Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, interstitial lung disease, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
• History of another primary malignancy except for
• Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• Adequately treated carcinoma in situ without evidence of disease
• History of active primary immunodeficiency.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

durvalumab; Drug Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Li Zhang, MD

CONTACT

+86 13911339836; zhanglipumch@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 17, 2020
• Study Start: July 28, 2020
• Primary Completion: June 1, 2021
• Study Completion: October 1, 2024
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)