Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Immune checkpoint inhibitor
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- Hunan Province Tumor Hospital
- Enrollment
- 15000
- Locations
- 1
- Primary Endpoint
- Progression-free survival (PFS)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed 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.
Investigators
Yongchang Zhang
Professor, Director of Clinical Trial Center
Hunan Province Tumor Hospital
Eligibility Criteria
Inclusion Criteria
- •≥18，Lung Cancer Confirmed by Histopathology
- •Treated with Chemotherapy with or Without Checkpoint Inhibitors.
- •Predicted survival ≥ 12 weeks.
- •Adequate bone marrow hematopoiesis and organ function
- •Presence of measurable lesions according to RECIST 1.
- •Subjects with stable brain metastases may be included in the study.
Exclusion Criteria
- •Patients did not match for the Inclusion Criteria.
Arms & Interventions
Cohort A
Extansive Stage Small Cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors .
Intervention: Immune checkpoint inhibitor
Cohort B
Limit Stage Small Celll Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors .
Intervention: Immune checkpoint inhibitor
Cohort C
Small Celll Lung Cancer who progressed from first line treatment and received subsequential Chemotherapy with or without Checkpoint Inhibitors.
Intervention: Immune checkpoint inhibitor
Cohort D
Metastastic Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.
Intervention: Immune checkpoint inhibitor
Cohort E
Metastastic Non-small cell Lung Cancer who progressed from first line treatment and received subsequential Chemotherapy with or without Checkpoint Inhibitors.
Intervention: Immune checkpoint inhibitor
Cohort F
Resectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.
Intervention: Immune checkpoint inhibitor
Cohort G
Unresectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.
Intervention: Immune checkpoint inhibitor
Cohort H
Non-small cell Lung Cancer received neoadjuvent or adjuvent Chemotherapy with or without Checkpoint Inhibitors.
Intervention: Immune checkpoint inhibitor
Cohort I
Cohort I, Non-small cell Lung Cancer with EGFR, ALK and ROS1 sensitive mutation who received Chemotherapy with or without Checkpoint Inhibitors.
Intervention: Immune checkpoint inhibitor
Cohort J
Non-small cell Lung Cancer with other oncogenic mutation including RET, BRAF etc who received Chemotherapy with or without Checkpoint Inhibitors.
Intervention: Immune checkpoint inhibitor
Cohort K
Non-small cell Lung Cancer received Chemotherapy plus bevacizumab with or without Checkpoint Inhibitors.
Intervention: Immune checkpoint inhibitor
Cohort L
Non-small cell Lung Cancer who enrolled in clinical trials.
Intervention: Immune checkpoint inhibitor
Outcomes
Primary Outcomes
Progression-free survival (PFS)
Time Frame: Time from first subject dose to study completion, or up to 36 month
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
Secondary Outcomes
- Overall survival (OS)(Time from first subject dose to study completion, or up to 36 months.)
- Duration of Response (DOR)(Time from first subject dose to study completion, or up to 36 month)
- Patient reported outcome(Time from first subject dose to study completion, or up to 36 months.)
- Objective Response Rate (ORR)(Time from first subject dose to study completion, or up to 36 months.)
- Adverse events (AEs) according to CTCAE 5.0(From first dose until 28 days after the last dose, up to 24 month)