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

Lung Squamous Cell Carcinoma Stage IV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04306042
• Other study ID #: CTONG1904
• Status: Not yet recruiting
• Start date: March 2020
• Est. completion date: December 2022

Study information

• Verified date: March 2020
• Source: Guangdong Association of Clinical Trials
• Contact: Chongrui Xu
• Phone: 86-20-838278812
• Email: xucr001[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 2022
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Lung Squamous Cell Carcinoma Stage IV

Intervention

Drug:
• Nivolumab or Pembrolizumab
Nivolumab or Pembrolizumab

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Association of Clinical Trials

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2 year survival rate		2 years
Primary	objective response rate		2 years
Primary	disease control rate	free survival	2 years
Primary	median progression free survival		2 years
Secondary	incidence of adverse reactions	Safety of the combination of PD-1 and chemotherapy	2 years