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Study on markers of immunotherapy efficacy of non-small cell lung cancer

A Study for Identification of Predictive Biomarkers for Anti-PD-1 Immunotherapy in NSCLC Patients Based on NGS Platform

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100047352
Enrollment
Unknown
Registered
2021-06-12
Start date
2021-06-12
Completion date
Unknown
Last updated
2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer

Interventions

Observation group:none

Sponsors

Changzheng Hospital, Shanghai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. AJCC TNM staging (8th edition) stage IIIB/IV NSCLC patients diagnosed by histology or cytology, including histopathological subtypes such as lung adenocarcinoma and lung squamous cell carcinoma; 2. Have not received first-line anti-tumor systemic therapy for advanced NSCLC in the past; 3. The patients ECOG score is 0-1 points, and the physical condition and organ function allow for anti-tumor systemic treatment, including standard chemotherapy and immunotherapy, without immunotherapy contraindications; 4. Aged 18-80 years when signing the informed consent form; 5. At baseline, tissue NGS testing and PD-L1 (22C3) have been used to detect gene mutation status and PD-L1 expression status; and EGFR, ALK, ROS1, BRAF, MET 14 exon skipping and RET gene sensitive mutations are negative; 6. The patient has the ability to follow the planned schedule and actively cooperate with returning to the hospital for regular clinical follow-up and necessary treatment; 7. Can provide the clinical data needed for research, and be willing to use the test data for further scientific research utilization and commercial product development; 8. The functional reserve of important organs meets the following requirements: absolute neutrophil count >=1.5x10^9/L; platelets >= 90x10^9/L; hemoglobin >= 9.0g/dL; albumin level >= 2.8 g/L; Serum total bilirubin <= 1.5 x upper limit of normal ULN; total bilirubin in subjects with liver metastasis or liver cancer <= 2 x ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 x ULN; For subjects with liver metastases, ALT and AST <= 5xULN; serum creatinine <= 1.5xULN; international normalized ratio (INR) or plasma prothrombin time (PT)<= 1.5xULN.

Exclusion criteria

Exclusion criteria: 1. There are other malignant tumors at the same time; 2. Patients who have previously received systemic anti-tumor therapy for advanced NSCLC without NGS test results on blood samples before the start of treatment; 3. As judged by the investigator, patients who also suffer from other serious diseases that may affect follow-up and/or significantly shorten survival; 4. Patients who are accompanied by any other medical conditions and social/psychological problems, etc., who are judged by the investigator to be unsuitable for participating in this study; 5. Patients who cannot accept the use of contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT) for clinical follow-up.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Countries

China

Contacts

Public ContactTang Hao

Changzheng Hospital, Shanghai

tanghao_0921@126.com+86 13816033045

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026