ctDNA as a Biomarker for Treatment in Advanced NSCLC

Sponsor

Fuzhou General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05486988

Collaborator

(none)

500

Enrollment

Location

Anticipated Duration (Months)

14.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Drug: Immunotherapy Drug: Chemotherapeutic Agent Drug: Chemotherapy

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Anticipated Study Start Date :

Jul 31, 2022

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
2 cycles chemotherapy combined with PD-1/PD-L1 inhibitors Participants receive 2 cycles chemotherapy combined with PD-1/PD-L1 inhibitors, after achieving CR/PR/SD according to RECIST v1.1, then will continue immune monotherapy maintenance therapy.	Drug: Immunotherapy PD-1/PD-L1 inhibitors Drug: Chemotherapeutic Agent 2 cycles
4-6 cycles chemotherapy combined with PD-1/PD-L1 inhibitors Participants receive 4~6 cycles chemotherapy combined with PD-1/PD-L1 inhibitors, after achieving CR/PR/SD according to RECIST v1.1, then will continue immune monotherapy maintenance therapy.	Drug: Immunotherapy PD-1/PD-L1 inhibitors Drug: Chemotherapy 4~6 cycles

Arm

Intervention/Treatment

2 cycles chemotherapy combined with PD-1/PD-L1 inhibitors

Participants receive 2 cycles chemotherapy combined with PD-1/PD-L1 inhibitors, after achieving CR/PR/SD according to RECIST v1.1, then will continue immune monotherapy maintenance therapy.

Drug: Immunotherapy

PD-1/PD-L1 inhibitors

Drug: Chemotherapeutic Agent

2 cycles

4-6 cycles chemotherapy combined with PD-1/PD-L1 inhibitors

Participants receive 4~6 cycles chemotherapy combined with PD-1/PD-L1 inhibitors, after achieving CR/PR/SD according to RECIST v1.1, then will continue immune monotherapy maintenance therapy.

Drug: Immunotherapy

PD-1/PD-L1 inhibitors

Drug: Chemotherapy

4~6 cycles

Outcome Measures

Primary Outcome Measures

Change in ctDNA Level Following Chemo-immunotherapy [up to 1 year]
Will be assessed for ctDNA levels at baseline, end of chemotherapy, and immunotherapy maintenance

Secondary Outcome Measures

Progression-free survival [up to 1 year]
From the date of treatment until the date of progression of lung cancer or death from any other cause assessed up to 12 months
Overall survival [up to 24 months]
From the date of treatment until the date of death from any cause assessed up to 24 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.