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

• Sponsor: Guangdong Association of Clinical Trials (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04306042
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 33
• Patients Per Site Per Month: 30.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Squamous Cell Carcinoma Stage IV	Drug: Nivolumab or Pembrolizumab

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Survival Observational Study in Patients With Advanced IIIB-IV Squamous Cell Lung Cancer Receiving PD-1 Combination With Chemotherapy (RESPONSE)
• Anticipated Study Start Date: Mar 1, 2020
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 2 year survival rate [2 years]

2. objective response rate [2 years]

3. disease control rate [2 years]

   free survival

4. median progression free survival [2 years]

Secondary Outcome Measures

1. incidence of adverse reactions [2 years]

   Safety of the combination of PD-1 and chemotherapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong Provincial People's Hospital	Guangzhou	Guangdong	China	510080

Sponsors and Collaborators

• Guangdong Association of Clinical Trials

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guangdong Association of Clinical Trials
• ClinicalTrials.gov Identifier: NCT04306042
• Other Study ID Numbers: CTONG1904
• First Posted: Mar 12, 2020
• Last Update Posted: Mar 12, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma, Squamous Cell; Pembrolizumab; Nivolumab

Study Results

No Results Posted as of Mar 12, 2020