NCT04306042

Brief Summary

This is a multi-center, open-label, non-interventional, retrospective registry study, with no pre-set statistical assumptions and will not intervene subject's clinical treatment or clinical management. In the study, the clinical data of the subjects will be retrospectively collected from the electronic health records (EHR) of each research center. The clinical information will be based on the actual medical records of the cases. After the retrospective study time (June 30, 2020), patients will be followed for one-year and two-year survival. Clinical treatment and management will be based on local clinical practices and regulations. This study will record the actual diagnosis and treatment, and will not interfere with any clinical decision. After subject-out, patients will be followed for one-year and two-year survivals, thus the follow-up consent will be exempted. All patients receiving PD-1 monoclonal antibody in combination with chemotherapy will be visited during the entire study period. At the end of study, investigator will check up on the conditions of patients who withdraw from the study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

9 months

First QC Date

February 11, 2020

Last Update Submit

March 11, 2020

Conditions

Lung Squamous Cell Carcinoma Stage IV

Outcome Measures

Primary Outcomes (4)

  • 2 year survival rate

    2 years

  • objective response rate

    2 years

  • disease control rate

    free survival

    2 years

  • median progression free survival

    2 years

Secondary Outcomes (1)

  • incidence of adverse reactions

    2 years

Study Arms (1)

Treatment

Patients diagnosed with primary stage IIIB-IV squamous cell lung cancer and treated in 92 medical centers between 01 September 2019 and 30 June 2020 will be targeted for study inclusion.

Drug: Nivolumab or Pembrolizumab

Interventions

Nivolumab or PembrolizumabDRUG

Nivolumab or Pembrolizumab

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with primary stage IIIB-IV squamous cell lung cancer and treated in 92 medical centers.

You may qualify if:

  • Men and woman, aged over 18
  • Cytology or histologically confirmed squamous cell lung cancer
  • Advanced squamous cell lung cancer, Stage IIIb to IV according to AJCC staging (version 8)
  • Patients receiving approved PD-1 mAb in combination with chemotherapy according to their condition
  • Patients receiving PD-1 mAb in combination with chemotherapy for at least one cycle (21 days)
  • Have imaging results with measurable tumor 2 weeks before receiving PD-1 mAb in combination with chemotherapy
  • Able to understand and comply with the requirements of the consent and voluntarily participate in the study

You may not qualify if:

  • Patients participating in other clinical studies
  • Severe medical data missing
  • Unable to understand the purpose of the study or not agree with the requirement of the study
  • Malignancies other than squamous cell lung cancer, history of malignancies
  • Unsuitable for the study according to investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Interventions

Nivolumabpembrolizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Chongrui Xu

CONTACT

86-20-838278812xucr001@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2020

First Posted

March 12, 2020

Study Start

March 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2022

Last Updated

March 12, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

Patients information without identification data will be shared within centers enrolled in the study to perform the data analysis.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN(1)