Status:
UNKNOWN
Investigation on Predictive Molecular Markers of Efficacy for Front-line Immunochemotherapy in Advanced NSCLC
Lead Sponsor:
Zhou Chengzhi
Conditions:
Biomarkers
Eligibility:
All Genders
18+ years
Brief Summary
This project is a real-world exploratory study aiming to explore potential molecular markers detectable at baseline that can enable the prediction of clinical efficacy of front-line immunotherapy comb...
Eligibility Criteria
Inclusion
- Patients who are clinically diagnosed with stage IV NSCLC;
- Patients who submitted samples for molecular testing using the OncoScreen Plus panel and PD-L1 (22C3) immunohistochemistry test at baseline;
- Patients with negative results for sensitizing mutations for 6 genes, including EGFR, ALK, ROS1, BRAF, MET exon 14 skipping, and RET;
- Patients without contraindications for immunotherapy;
- Patients who are 18 years or older at the time of signing the informed consent form;
- Patients with life expectancy of at least 12 weeks;
- Patients with ECOG score of 0 or 1;
- Patients with adequate organ function defined by the following criteria:
- Absolute neutrophil count ≥ 1.5109/L;
- Platelets ≥ 90109/L;
- Hemoglobin ≥ 9.0g/dL;
- Albumin levels ≥2.8 g/L;
- Total serum bilirubin ≤ 1.5 the upper limit of normal (ULN); for patients with liver metastases, total bilirubin ≤ 2 ULN;
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN; for patients with liver metastases, ALT and AST ≤ 5ULN;
- Serum creatinine ≤ 1.5 ULN;
- International normalized ratio (INR) or plasma prothrombin time (PT) ≤1.5ULN.
Exclusion
- Patients with other concurrent tumors;
- Patients with other concurrent medical conditions that may affect their follow-up and short-term survival;
- Patients with any history of immunotherapy;
- Patients with any history of chemotherapy, radiotherapy or other anti-tumor treatments;
- Patients with heart function classified as New York Heart Association (NYHA) class III or IV;
- Patients with peripheral nerve disease;
- Patients with confirmed hearing loss;
- Patients with other conditions deemed unsuitable for enrollment by the researchers.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04858828
Start Date
June 1 2021
End Date
March 1 2024
Last Update
April 26 2021
Active Locations (1)
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1
Zhou Chengzhi
Guangzhou, Guangdong, China, 510120