Clinical trial NCT05486988: ctDNA as a Biomarker for Treatment in Advanced NSCLC
Official title: A Prospective，Randomized, Multi-center Study to Identify the Patients Who Benefit From Short-course Chemotherapy (2 Cycles) in Combination With Immunotherapy as Treatment for Patients With Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer (TLUNG)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non-small Cell Lung Cancer
Keywords: Circulating Tumor DNA
immunotherapy
chemotherapy (2/4~6 cycles)
Lead sponsor: Fuzhou General Hospital
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Change in ctDNA Level Following Chemo-immunotherapy
timeFrame: up to 1 year
Secondary outcomes:
measure: Progression-free survival
timeFrame: up to 1 year
measure: Overall survival
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: 900TH Hospital of Joint Logisti'cs Support Force
state: Fujian
Study officials:
References: