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Trial Title:
ctDNA as a Biomarker for Treatment in Advanced NSCLC
NCT ID:
NCT05486988
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents
Conditions: Keywords:
Circulating Tumor DNA
immunotherapy
chemotherapy (2/4~6 cycles)
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Immunotherapy
Description:
PD-1/PD-L1 inhibitors
Arm group label:
2 cycles chemotherapy combined with PD-1/PD-L1 inhibitors
Arm group label:
4-6 cycles chemotherapy combined with PD-1/PD-L1 inhibitors
Intervention type:
Drug
Intervention name:
Chemotherapeutic Agent
Description:
2 cycles
Arm group label:
2 cycles chemotherapy combined with PD-1/PD-L1 inhibitors
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
4~6 cycles
Arm group label:
4-6 cycles chemotherapy combined with PD-1/PD-L1 inhibitors
Summary:
The dynamic monitoring of circulating tumor DNA aims to evaluate the response and
progression-free survival of short-course chemotherapy (2 cycles) combined with
immunotherapy in patients with locally advanced unresectable or metastatic non-small cell
lung cancer.
Detailed description:
For patients with locally advanced unresectable or metastatic non-small cell lung
cancers, 4-6 cycles of chemotherapy plus immunotherapy with immune maintenance therapy is
currently the standard treatment. Short-course chemotherapy (2 cycles) combined with
immunotherapy has been proved effective in some patients. Recently, circulating tumor DNA
(ctDNA) has been detected in the cell-free component of peripheral blood samples in
advanced non-small cell lung cancers and many other solid tumors. To identify the
patients who can benefit from the short-course chemotherapy (2 cycles) combined with
immunotherapy, dynamic monitoring of ctDNA in both 4-6 cycles and 2 cycles chemotherapy
patients could be a promising alternative test.
Criteria for eligibility:
Study pop:
Male or female aged over 18 years and under 80 years with locally advanced unresectable
or metastatic non-small cell lung cancer, and no prior immunotherapy.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- (1)Histologically confirmed non-small cell lung cancer; (2)Locally advanced
unresectable or metastatic disease; (3)Male or female aged over 18 years and under
80 years; (4)Subjects must not have received any immunotherapy for advanced lung
cancer, and have an estimated life expectancy of more than 12 weeks (5)Eastern
Cooperative Oncology Group (ECOG) score as 0 ~ 1; (6)No EGFR mutation, ALK or ROS1
rearrangement; (7)Adequate tumor tissue for PD-L1 testing; (8)With at least one
measurable lesion confirmed by the investigator according to Response Evaluation
Criteria in Solid Tumors (RECIST) (version 1.1)； (9)The subjects must sign the
informed consent, indicating that they understand the purpose of the study,
understand the necessary procedures of the study, and are willing to participate in
the study.
Exclusion Criteria:
- (1)Serious immune-related adverse events occurred; (2)Participation in other
clinical study; (3)With the history of autoimmune disease or immunodeficiency
disease; (4)History of another primary malignancy within 5 years; (5)Without
complete clinical information; (6)Pregnant or lactating women; (7)Other conditions
in which the investigator believes that the patient should not participate in this
trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
900TH Hospital of Joint Logisti'cs Support Force
Address:
City:
Fuzhou
Zip:
350025
Country:
China
Contact:
Last name:
Zongyang YU, PhD
Phone:
13509327806
Email:
yuzy527@sina.com
Contact backup:
Last name:
Ying CHEN, Master
Phone:
19959234577
Email:
44588449@qq.com
Start date:
July 31, 2022
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Fuzhou General Hospital
Agency class:
Other
Source:
Fuzhou General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05486988
