Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors
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: Pemetrexed plus Pembrolizumab, Pembrolizumab, Pemetrexed.
- Who it may be relevant to
- Registry conditions: 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 →
Official title
Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors With or Without Chemotherapy
Overview
The purpose of the study is to find some biomarkers to predict the the adverse events of Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy in lung cancer.
Detailed description
The purpose of the study is to find some biomarkers to predict the the adverse events of Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy in lung cancer.
Step 1: All the lung cancer patients treated with Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy were enrolled in this study.
Step 2: All the adverse events were evaluated by principal investigator. Step 3: All the blood and FFPE samples were collected for further anaysis. Step 4: Correlation between adverse events and gene profile was analysis. Step 4: Predict model was construted with AI.
Interventions
- Drug Pemetrexed plus Pembrolizumab
Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc. Pemetrexed, 500mg/m2, ivgtt, every 21 days - Drug Pembrolizumab
Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc. - Drug Pemetrexed
Pemetrexed, 500mg/m2, ivgtt, every 21 days etc.
Primary outcome measures
- Correlation between Adverse events (AEs) and gene profile [Time frame: Time from first subject dose to study completion, or up to 36 month]
Secondary outcome measures (2)
- Adverse events (AEs) rate according to CTCAE 5.0 [Time frame: Time from first subject dose to study completion, or up to 36 month]
- Correlation between Adverse events (AEs) and survival outcome [Time frame: Time from first subject dose to study completion, or up to 36 month]
Eligibility criteria
Inclusion criteria
- Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
- Age ≥ 18 years.
- Histologically or cytologically confirmed lung cancer.
- Treated with Immune Checkpoint Inhibitors with or without chemotherapy.
6\. Predicted survival ≥ 12 weeks. 7. Adequate bone marrow hematopoiesis and organ function 8. Presence of measurable lesions according to RECIST 1.1.
Exclusion criteria
Any conditions can not match for the Inclusion Criteria, includign do not have the data to perform Adverse Events evalutation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Hunan Cancer Hospital — Changsha
Identifiers
NCT: NCT05055908 · 20210913