Non Small Cell Lung Cancer
Conditions
Keywords
Chemotherapy, Immune Checkpoint Inhibitors
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.
Interventions
DRUGImmune checkpoint inhibitor
Chemotherapy follow the guild line.
Sponsors
Hunan Province Tumor Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
Countries
China
Contacts
Primary ContactYongchang Zhang, MD
Backup ContactNong Yang, MD
Outcome results
None listed