ctDNA as a Biomarker for Treatment in Advanced NSCLC

Non-small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05486988
• Other study ID #: SCOG006
• Status: Not yet recruiting
• Start date: July 31, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2022
• Source: Fuzhou General Hospital
• Contact: Zongyang Yu, Ph.D
• Phone: 13509327806
• Email: yuzy527[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Immunotherapy
PD-1/PD-L1 inhibitors
• Chemotherapeutic Agent
2 cycles
• Chemotherapy
4~6 cycles

Locations

Country	Name	City	State
China	900TH Hospital of Joint Logisti'cs Support Force	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fuzhou General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ctDNA Level Following Chemo-immunotherapy	Will be assessed for ctDNA levels at baseline, end of chemotherapy, and immunotherapy maintenance	up to 1 year
Secondary	Progression-free survival	From the date of treatment until the date of progression of lung cancer or death from any other cause assessed up to 12 months	up to 1 year
Secondary	Overall survival	From the date of treatment until the date of death from any cause assessed up to 24 months	up to 24 months