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Trial Title:
Prediction Model of ICIs Combined With Chemotherapy in Advanced NSCLC
NCT ID:
NCT05725915
Condition:
Lung Cancer, Nonsmall Cell
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
The reliable predictive markers to identify which patients with advanced non-small cell
lung cancer tumors will achieve durable clinical benefit for chemo-immunotherapy are
needed. This study is a real world study, aiming to establish a multi-parameter model to
predict the efficacy of immune checkpoint inhibitor(ICI) combined with chemotherapy, and
to explore the correlation and predictive value of each single biomarker, so as to assist
physician to select patients who may benefit for a long time as early as possible and
guide clinical accurate treatment.
Criteria for eligibility:
Study pop:
Patients diagnosed with inoperable stage IIIB to IV NSCLS using immune checkpoint
inhibitors in combination with chemotherapy.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Male and female, ≥18 years old;
2. Patients with a definite cytological or histopathological diagnosis of non-small
cell lung cancer;
3. Locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC unable to receive
radical surgery and/or radical radiotherapy (with or without concurrent
chemotherapy) (AJCC cancer stage 8 clinical stage)
4. There is no known ALK gene translocation
5. For patients with EGFR-negative non-squamous cell carcinoma, or patients with
EGFR-negative/unknown squamous cell carcinoma, it is required that they have not
received systemic antitumor therapy for advanced NSCLC in the past (patients have
received neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy or
chemoradiotherapy for curing non-metastatic disease in the past, A disease-free
interval of ≥6 months was required between the last chemotherapy and/or
radiotherapy).
6. Patients with non-squamous cell carcinoma with EGFR-sensitive mutation and EGFR TKI
progression could be enrolled if they met any of the following requirements:
Progress in Treatment of 1/2 generation EGFR TKI, T790M-; EGFR TKI treatment
progress of 1/2 generation, T790M+, after 3 generations of EGFR TKI treatment
progress again; T790M status was not considered in patients who had progressed to
the initial 3 generations of EGFR TKI therapy.
7. At least 1 measurable lesion according to RECIST 1.1
8. Receiving immune checkpoint inhibitor therapy for more than 2 cycles
9. ECOG PS 0-1 score
10. Be able to understand and abide by the requirements of the agreement, and
voluntarily participate in the study.
Exclusion Criteria:
1. Patients participating in other clinical studies;
2. Patients with serious lack of diagnosis and treatment data;
3. Patients could not understand the purpose of the study or disagreed with the
requirements of the study;
4. A history of other tumors within 5 years;
5. Patients judged by the researchers as not suitable for inclusion in this study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shuhua Han
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Shuhua Han, docter
Phone:
13585148267
Email:
hanshuhua0922@126.com
Start date:
December 1, 2022
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Beijing Red Clove Public Welfare Development Center
Agency class:
Other
Source:
Beijing Red Clove Public Welfare Development Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05725915
