ctDNA as a Biomarker for Treatment in Advanced NSCLC

NCT05486988 | Unknown

• 1 other identifier: SCOG006
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Circulating Tumor DNA; immunotherapy; chemotherapy (2/4~6 cycles)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progression-free survival

  up to 1 year

• Overall survival

  up to 24 months

Study Arms (2)

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; Drug: Chemotherapeutic Agent

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; Drug: Chemotherapy

Interventions

Immunotherapy DRUG

PD-1/PD-L1 inhibitors

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

Chemotherapeutic Agent DRUG

2 cycles

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

Chemotherapy DRUG

4\~6 cycles

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Fuzhou General Hospital: lead

Study Sites (1)

900TH Hospital of Joint Logisti'cs Support Force

Fuzhou, Fujian, 350025, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

circulating tumor DNA (ctDNA) of peripheral blood samples

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Immunotherapy; Antineoplastic Agents; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Zongyang Yu, Ph.D

CONTACT

13509327806; yuzy527@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: July 31, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)