Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immune checkpoint inhibitor.
- Who it may be relevant to
- Registry conditions: Non Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Drug Immune checkpoint inhibitor
Chemotherapy follow the guild line.
Primary outcome measures
- Progression-free survival (PFS) [Time frame: Time from first subject dose to study completion, or up to 36 month]
Secondary outcome measures (5)
- Overall survival (OS) [Time frame: Time from first subject dose to study completion, or up to 36 months.]
- Objective Response Rate (ORR) [Time frame: Time from first subject dose to study completion, or up to 36 months.]
- Duration of Response (DOR) [Time frame: Time from first subject dose to study completion, or up to 36 month]
- Adverse events (AEs) according to CTCAE 5.0 [Time frame: From first dose until 28 days after the last dose, up to 24 month]
- Patient reported outcome [Time frame: Time from first subject dose to study completion, or up to 36 months.]
Eligibility criteria
Inclusion criteria
- ≥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.
Exclusion criteria
Patients did not match for the Inclusion Criteria.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Hunan Cancer Hospital — Changsha
Identifiers
NCT: NCT05059951 · 20210113