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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Extansive Stage Small Cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors . |
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| Cohort B | Limit Stage Small Celll Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors . |
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| Cohort C | Small Celll Lung Cancer who progressed from first line treatment and received subsequential Chemotherapy with or without Checkpoint Inhibitors. |
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| Cohort D | Metastastic Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors. |
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| Cohort E | Metastastic Non-small cell Lung Cancer who progressed from first line treatment and received subsequential Chemotherapy with or without Checkpoint Inhibitors. |
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| Cohort F |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immune checkpoint inhibitor | Drug | Chemotherapy follow the guild line. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
Patients did not match for the Inclusion Criteria.
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Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongchang Zhang, MD | Contact | +8613873123436 | 7+861383123436 | zhangyongchang@csu.edu.cn |
| Nong Yang, MD | Contact | +8613873123436 | +8613873123436 | yangnong0217@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongchang Zhang, MD | Hunan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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tissue sample and plasma DNA was obtained with the permission of patients.
Resectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.
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| Cohort G | Unresectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors. |
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| Cohort H | Non-small cell Lung Cancer received neoadjuvent or adjuvent Chemotherapy with or without Checkpoint Inhibitors. |
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| Cohort I | Cohort I, Non-small cell Lung Cancer with EGFR, ALK and ROS1 sensitive mutation who received Chemotherapy with or without Checkpoint Inhibitors. |
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| Cohort J | Non-small cell Lung Cancer with other oncogenic mutation including RET, BRAF etc who received Chemotherapy with or without Checkpoint Inhibitors. |
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| Cohort K | Non-small cell Lung Cancer received Chemotherapy plus bevacizumab with or without Checkpoint Inhibitors. |
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| Cohort L | Non-small cell Lung Cancer who enrolled in clinical trials. |
|
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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. |
| 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 |
| 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 |
| 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. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D013812 | Therapeutics |