Evaluation System for the Efficacy of Immunologic Checkpoint Inhibitors in NSCLC

Non Small Cell Lung Cancer Clinical Trial

Official title:

Establishment of a Comprehensive Evaluation System for the Efficacy of Immunologic Checkpoint Inhibitors in the Treatment of Advanced Non-small Cell Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04629027
• Other study ID #: 2020-2-2153
• Status: Not yet recruiting
• Start date: March 3, 2021
• Est. completion date: May 30, 2023

Study information

• Verified date: February 2021
• Source: Beijing Cancer Hospital
• Contact: Jian Fang
• Phone: +861088196478
• Email: fangjian5555[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Inhibitors of programmed cell death protein 1 (PD-1) and programmed cell death ligand 1 (PD-L1) are effective therapies for metastatic NSCLC lacking sensitizing EGFR or ALK mutations. First-line combination regimens that include a PD-1 or PD-L1 inhibitor may maximize the chance of response and lead to prolonged survival. PD-L1 expression is the only validated predictive biomarker for selecting pembrolizumab treatment. However, it is far from being the ideal biomarker and its role in predicting efficacy from ICPIs remains undefined due to conflicting results from randomized clinical trials. The selection of patients most likely to benefit from immunotherapy is crucial in order to avoid exposure to potentially toxic and ineffective drugs as well as to prevent inappropriate allocation of health resources. Further studies are clearly needed to better understand the mechanism of action of immunotherapy in vivo thus allowing the identification of other predictive biomarkers. Therefore, our research team intends to explore advanced non-small cell lung cancer treated with immune checkpoint inhibitors, by combining the evaluation criteria of solid tumor efficacy evaluation criteria (RECIST1.1), clinical pathological characteristics of patients, and dynamic monitoring of peripheral blood molecular biological markers, finding the correlation with the efficacy of immunotherapy, establish a detection mode for selecting patients with clinical benefits.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Ages =18 years of age. Histologically confirmed stage IIIB-IV non-squamous non-small cell lung cancer. Life expectancy of at least 3 months.

Exclusion Criteria:

• Previous treatment . Untreated CNS metastases. Active autoimmune disease. Surgery or significant traumatic injury. Active infection. History of allergy or hypersensitivity to immunotherapy components. Women are breastfeeding or pregnant. Requiring systemic treatment with either corticosteroids or other immunosuppressive medications.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Immune checkpoint inhibitor
the patients receive necessary treatment without special intervention

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	circulating tumor cell	The selection of patients most likely to benefit from immunotherapy is crucial in order to avoid exposure to potentially toxic and ineffective drugs.	3 year
Primary	T cell marker	The selection of patients most likely to benefit from immunotherapy is crucial in order to avoid exposure to potentially toxic and ineffective drugs.	3 year