Clinical trial NCT04996927: 18F-FDG PET/CT to Evaluate pD-1 Monoclonal Antibody With First-line Chemotherapy in Advanced NSCLC
Official title: A Prospective, Single-arm, Observational Clinical Study Based on 18F-FDG PET/CT to Evaluate the True Efficacy and Immune Response of PD-1 Monoclonal Antibody Combined With First-line Chemotherapy in Advanced Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NSCLC
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histologically or cytologically confirmed stage IIIb-IV non-small cell lung cancer (according to the International Association for the Study of Lung Cancer Chest Tumor Staging Manual, Edition 7. IASLC Staging Manual in Thoracic Oncology. The patient's tumor must lack an EGFR-sensitive mutation (i.e. exon 19 deletion, or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S7681 mutation) and ALK rearrangement.Patients must provide a biopsy for PD-L1 testing. The World Health Organization (WHO)/ Eastern Collaborative Oncology Group (ECOG) physical status score was 0 or 1 at the time of enrollment. At least 1 lesion (no previous radiotherapy) whose longest diameter ≥10mm was accurately measured by CT or MRI at baseline. Must have a life expectancy of at least 12 weeks.

Brief summary: This study is a diagnostic study. Subjects were enrolled from clinical stage IIIB or IV NSCLC patients who received standard first-line chemotherapy combined with PD-1 monoclonal antibody immunotherapy and received 18F-FDG PET/CT imaging before treatment, after 2 courses of treatment, and at the time of disease progression.At the same time, the blood routine, liver and kidney function, inflammatory indexes and other laboratory data of the subjects participating in the study were collected. Based on 18F-FDG PET Ipercist standard and comprehensive laboratory indicators, the subjects were evaluated for tumor biological characteristics prediction and clinical staging, PD-1 immune efficacy monitoring and evaluation, tumor recurrence monitoring and re-staging. At the same time, the systemic immune response and immune-related adverse events during the treatment process were evaluated in order to establish a better evaluation standard and system for the comprehensive evaluation of PD-1 immunotherapy.This study plans to set the sample size as 50 cases.

Detailed description: This is a diagnostic study. Subjects were enrolled from clinical stage IIIB or IV NSCLC patients who received standard first-line chemotherapy combined with PD-1 monoclonal antibody immunotherapy and underwent 18F-FDG PET/CT imaging before treatment, after two lines of treatment and at the time of disease progression, while routine blood counts, liver and kidney function, inflammatory indices and other laboratory data were collected from subjects enrolled in the study. Based on standard 18F-FDG PET Ipercist and comprehensive laboratory indicators, subjects were evaluated for prediction of tumour biological characteristics and clinical staging, monitoring and evaluation of PD-1 immune efficacy, monitoring of tumour recurrence and restaging. At the same time, the systemic immune response and immune-related adverse events during the treatment process were evaluated to establish a better evaluation standard and system for the comprehensive evaluation of PD-1 immunotherapy.

Eligibility criteria: Inclusion Criteria:

* Adult patients (age 18 or above), gender unlimited;
* Pathological diagnosis of non-small cell lung cancer stage IIIB or above;
* Agree to carry out the standard first-line chemotherapy combined with immunosuppression established in this study;
* Consent to 18F-FDG PET/CT imaging and related laboratory examination before and during treatment;
* The patients themselves or their legal representatives are aware of this study and can sign the informed consent.

Exclusion Criteria:

* Acute systemic diseases and electrolyte disturbances;
* Pregnant or lactating women;
* The patient or his legal representative is unable or unwilling to sign the informed consent.

Primary outcomes:
measure: Sensitivity and specificity of 18F-FDG PET/CT for diagnosis the true efficacy and immune response of Non-small Cell Lung Cancer
timeFrame: 2 years
Secondary outcomes:
measure: Change after treatment
timeFrame: 2 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: China, Hubei Province
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Xiaoli Lan, PhD
role: STUDY_DIRECTOR
References: