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The feasibility study of targeted curative effect prediction and precise treatment based on ctDNA dynamic monitoring for advanced NSCLC patients with newly diagnosed driver gene positive

The feasibility study of targeted curative effect prediction and precise treatment based on ctDNA dynamic monitoring for advanced NSCLC patients with newly diagnosed driver gene positive

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083724
Enrollment
Unknown
Registered
2024-04-30
Start date
2022-02-07
Completion date
Unknown
Last updated
2024-05-06

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

Group A:TKI combined with chemotherapy
Group B:TKI monotherapy

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. AJCC TNM staging (8th edition) stage IIIB/IV NSCLC patients confirmed 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 physical condition and organ function allow to carry out anti-tumor systemic treatment, including standard chemotherapy and immunopharmaceutical treatment; 4.When signing the informed consent form, the age is =18 years old; 5.Have NGS test results of blood samples and/or tumor tissue samples before the start of first-line treatment; 6. First-line patients who intend to carry out standardized treatment; 7.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; 8. 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. 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. Patients who have previously received systemic anti-tumor therapy for advanced NSCLC but 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;progression free survival;

Secondary

MeasureTime frame
Overall survival;Objective response rate;Disease control rate;

Countries

China

Contacts

Public ContactXiang Yi

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

xiangyiht@163.com+86 138 1696 7846

Outcome results

None listed

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