A Survival Observational Study in Patients With Advanced IIIB-IV Squamous Cell Lung Cancer Receiving PD-1 Combination With Chemotherapy

A Survival Observational Study in Patients With Advanced IIIB-IV Squamous Cell Lung Cancer Receiving PD-1 Combination With Chemotherapy (RESPONSE)

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.

Study Overview

• Status: Unknown
• Conditions: Lung Squamous Cell Carcinoma Stage IV
• Intervention / Treatment: Drug: Nivolumab or Pembrolizumab

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Chongrui Xu; Phone Number: 50816 86-20-838278812; Email: xucr001@gmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital
      • Contact: Chongrui Xu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Nivolumab or Pembrolizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective response rate		2 years
2 year survival rate		2 years
median progression free survival		2 years
disease control rate	free survival	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of adverse reactions	Safety of the combination of PD-1 and chemotherapy	2 years

Collaborators and Investigators

• Sponsor: Guangdong Association of Clinical Trials

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab; Pembrolizumab
• Other Study ID Numbers: CTONG1904

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patients information without identification data will be shared within centers enrolled in the study to perform the data analysis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No