ctDNA as a Biomarker for Treatment in Advanced NSCLC

Not yet recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Immunotherapy; Drug: Chemotherapeutic Agent; Drug: Chemotherapy

• Registration Number: NCT05486988
• Lead Sponsor: Fuzhou General Hospital

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.

Study Timeline

• Study Start: 2022-07-31
• Status Verified: 2022-08
• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-02
• Last Update Submitted: 2022-08-02
• Study First Posted: 2022-08-04
• Last Update Posted: 2022-08-04
• Primary Completion: 2024-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2 cycles chemotherapy combined with PD-1/PD-L1 inhibitors	Immunotherapy	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.
4-6 cycles chemotherapy combined with PD-1/PD-L1 inhibitors	Immunotherapy	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.
2 cycles chemotherapy combined with PD-1/PD-L1 inhibitors	Chemotherapeutic Agent	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.
4-6 cycles chemotherapy combined with PD-1/PD-L1 inhibitors	Chemotherapy	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

900TH Hospital of Joint Logisti'cs Support Force; 🇨🇳 Fuzhou, Fujian, China