Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Drug: Immune checkpoint inhibitor
- Registration Number
- NCT05059951
- Lead Sponsor
- Hunan Province Tumor Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15000
- ≥18，Lung Cancer Confirmed by Histopathology
- Treated with Chemotherapy with or Without Checkpoint Inhibitors.
- ECOG 0 - 1.
- Predicted survival ≥ 12 weeks.
- Adequate bone marrow hematopoiesis and organ function
- Presence of measurable lesions according to RECIST 1.1.
- Subjects with stable brain metastases may be included in the study.
Patients did not match for the Inclusion Criteria.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort H Immune checkpoint inhibitor Non-small cell Lung Cancer received neoadjuvent or adjuvent Chemotherapy with or without Checkpoint Inhibitors. Cohort I Immune checkpoint inhibitor Cohort I, Non-small cell Lung Cancer with EGFR, ALK and ROS1 sensitive mutation who received Chemotherapy with or without Checkpoint Inhibitors. Cohort J Immune checkpoint inhibitor Non-small cell Lung Cancer with other oncogenic mutation including RET, BRAF etc who received Chemotherapy with or without Checkpoint Inhibitors. Cohort K Immune checkpoint inhibitor Non-small cell Lung Cancer received Chemotherapy plus bevacizumab with or without Checkpoint Inhibitors. Cohort A Immune checkpoint inhibitor Extansive Stage Small Cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors . Cohort C Immune checkpoint inhibitor Small Celll Lung Cancer who progressed from first line treatment and received subsequential Chemotherapy with or without Checkpoint Inhibitors. Cohort F Immune checkpoint inhibitor Resectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors. Cohort B Immune checkpoint inhibitor Limit Stage Small Celll Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors . Cohort D Immune checkpoint inhibitor Metastastic Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors. Cohort E Immune checkpoint inhibitor Metastastic Non-small cell Lung Cancer who progressed from first line treatment and received subsequential Chemotherapy with or without Checkpoint Inhibitors. Cohort G Immune checkpoint inhibitor Unresectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors. Cohort L Immune checkpoint inhibitor Non-small cell Lung Cancer who enrolled in clinical trials.
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) 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 Outcome Measures
Name Time Method Overall survival (OS) Time from first subject dose to study completion, or up to 36 months. To assess overall survival, define as first dose to the death of the subject due to any cause
Duration of Response (DOR) Time from first subject dose to study completion, or up to 36 month 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
Patient reported outcome Time from first subject dose to study completion, or up to 36 months. Patient reported outcomes (PROs): A report that directly reflects a patient's assessment of their own health status.
Objective Response Rate (ORR) Time from first subject dose to study completion, or up to 36 months. To assess ICI and TKIs overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Adverse events (AEs) according to CTCAE 5.0 From first dose until 28 days after the last dose, up to 24 month Number of participants with adverse events (AEs) according to CTCAE 5.0
Trial Locations
- Locations (1)
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China