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Dynamic monitoring of ctDNA and prediction of immune efficacy in advanced NSCLC patients with wild-type gene and feasibility study based on ctDNA level intervention

Dynamic monitoring of ctDNA and prediction of immune efficacy in advanced NSCLC patients with wild-type gene and feasibility study based on ctDNA level intervention

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052222
Enrollment
Unknown
Registered
2021-10-22
Start date
2020-11-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

non-small cell lung cancer

Interventions

Part1:no intervention
Part 2 PD-L1>= 50%:with or without chemotherapy
Part 2 PD-L1< 50%:with or without chemotherapy

Sponsors

Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Stage III and IV non-small cell lung cancer confirmed by histopathology or cytology and determined by the investigator to be unresectable (International Association for the Study of Lung Cancer Eighth Edition Lung Cancer Staging). 2. Patients have not received first-line anti-tumor systemic therapy 3. The Eastern Cooperative Oncology Group (ECOG) physical status score is 0 or 1; 4. The physical condition and organ function allow to carry out anti-tumor systemic treatment, including standard chemotherapy and immunopharmaceutical treatment; 5. There is imaging to assess the lesion of tumor; 6. Patients with brain metastases are asymptomatic or have stable symptoms with local treatment; 7. The patients' age are over 18 years old when signs the informed consent form; 8. Blood samples and/or tumor tissue samples ,immune microenvironment-related multicolor immunofluorescence histochemical test results had collected before the start of first-line treatment NGS; 9. 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; 10. Patients who can provide the clinical data needed for research, and is willing to use the test data for further scientific research and commercial product development.

Exclusion criteria

Exclusion criteria: 1. Patients suffered from other active malignant tumors within 5 years before enrollment. Cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc. can be included in the group; 2. Advanced NSCLC patients who have previously received systemic anti-tumor therapy and have no baseline blood sample NGS test results 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 to participate 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
circulating tumor DNA;Programmed cell death 1 ligand 1;

Secondary

MeasureTime frame
basic vital signs;

Countries

China

Contacts

Public ContactXiang Yi

Shanghai Jiao Tong University School of Medicine

xiangyiht@163.com+86 13816967846

Outcome results

None listed

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