Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

— CREATE  

Official title:

Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05059951
• Other study ID #: 20210113
• Status: Recruiting
• Start date: October 3, 2021
• Est. completion date: March 1, 2028

Study information

• Verified date: June 2024
• Source: Hunan Province Tumor Hospital
• Contact: Yongchang Zhang, MD
• Phone: +8613873123436
• Email: zhangyongchang[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Although several clinical trials provide evidence for efficacy benefit for Checkpoint Inhibitors plus chemotherapy for lung cancer. However, there was rare evidence for clinical evidence in Hunan province.

Description:

This prospective study aimed to assess its efficacy and adverse event for Checkpoint Inhibitors with or without chemotherapy in clincial practice. Several cohorts were devided including pathological type, treatment line, treatment regiems, combination strategies. Tissue samples were collected with permission of patients for TME evaluation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: March 1, 2028
• Est. primary completion date: September 15, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. =18,Lung Cancer Confirmed by Histopathology

2. Treated with Chemotherapy with or Without Checkpoint Inhibitors.

3. ECOG 0 - 1.

4. Predicted survival = 12 weeks.

5. Adequate bone marrow hematopoiesis and organ function

6. Presence of measurable lesions according to RECIST 1.1.

7. Subjects with stable brain metastases may be included in the study.

Exclusion Criteria:

Patients did not match for the Inclusion Criteria.

Related Conditions & MeSH terms

• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Immune checkpoint inhibitor
Chemotherapy follow the guild line.

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	To assess progression-free survival of patients treated by different treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause	Time from first subject dose to study completion, or up to 36 month
Secondary	Overall survival (OS)	To assess overall survival, define as first dose to the death of the subject due to any cause	Time from first subject dose to study completion, or up to 36 months.
Secondary	Objective Response Rate (ORR)	To assess ICI and TKIs overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1	Time from first subject dose to study completion, or up to 36 months.
Secondary	Duration of Response (DOR)	To assess duration of response for subjects with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator , defined as the time from the first documented CR or PR to disease progression or death	Time from first subject dose to study completion, or up to 36 month
Secondary	Adverse events (AEs) according to CTCAE 5.0	Number of participants with adverse events (AEs) according to CTCAE 5.0	From first dose until 28 days after the last dose, up to 24 month
Secondary	Patient reported outcome	Patient reported outcomes (PROs): A report that directly reflects a patient's assessment of their own health status.	Time from first subject dose to study completion, or up to 36 months.