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Status unknownNCT04749407Updated Feb 11, 2021

Biomarkers of Stage III Locally Advanced Unresectable Non-small-cell Lung Cancer

An observational study in Non-small Cell Lung Cancer Stage III, sponsored by First People's Hospital of Hangzhou. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-02-11.

Sponsored by First People's Hospital of Hangzhou · Observational

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 70 Years
Sex
All
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Study summary

This study aims to dynamically monitor the expression profile status of peripheral blood mononuclear cells (PBMC) and the changes in circulating tumor DNA (ctDNA) levels in patients with stage III locally advanced unresectable non-small-cell lung cancer(NSCLC) after concurrent chemoradiotherapy or sequential chemoradiotherapy, and to explore biomarkers related to the immune microenvironment and the optimal time point for immunotherapy after chemoradiotherapy.

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Conditions studied

  • Non-small Cell Lung Cancer Stage III

Keywords

  • stage III locally advanced unresectable non-small-cell lung cancer
  • circulating tumor DNA
  • peripheral blood mononuclear cells
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 50 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

First People's Hospital of Hangzhou is the lead sponsor of 70 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with Stage III locally advanced unresectable Non-small cell lung cancer (NSCLC)

Inclusion criteria

  1. Provision of signed, written and dated informed consent prior to any study specific procedures
  2. Male or female aged over 18 years and under 70 years
  3. Patients must have histologically- or cytologically-documented NSCLC who present with locally advanced, unresectable (Stage III) disease (according to Version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology [IASLC Staging Manual in Thoracic Oncology]), and clinical evaluation is suitable for concurrent chemoradiotherapy or sequential chemoradiotherapy
  4. With measurable lesions (according to RECIST 1.1 criteria, long diameter of tumor lesions is 10mm, short diameter of lymph node lesions is 15mm).
  5. World Health Organization (WHO) Performance Status of 0\~2
  6. Life expectancy ≥6 months
  7. Adequate organ and marrow function as defined below:

    Absolute neutrophil count >1.5 x 109/L (1500 per mm3) Platelets >90 x 109/L (90,000 per mm3) Haemoglobin ≥9.0 g/dL (5.59 mmol/L) Serum creatinine CL >50 mL/min by the Cockcroft-Gault formula Serum bilirubin ≤1.5 x upper limit of normal (ULN) Total bilirubin (TBIL) ≤ 1.5 x upper limit of normal (ULN) In patients with no liver metastasis: AST and ALT ≤2.5 x ULN In patients with liver metastasis: AST or ALT ≤5 x ULN Urinary protein \<2+; If the urine protein is ≥2+, the 24-hour urine protein quantification must show the protein to be ≤1g

  8. International standardized ratio of normal coagulation function, no active bleeding and thrombosis disease International standardized ratio INR≤1.5×ULN Partial thromboplastin time APTT≤1.5×ULN Prothrombin time Pt ≤1.5 UlN
  9. For women of non-surgical sterilization or reproductive age, use of a medically approved contraceptive method (such as an intrauterine device, birth control pills, or condoms) during the study treatment period and within 3 months after the study treatment period; Women of reproductive age who are not surgically sterilized must be negative for serum or urine HCG within 7 days prior to study enrolment; And must be non-lactation; Male patients who are not surgically sterilized or of reproductive age need to agree to use a medically approved method of contraception with their spouse for the duration of the study treatment period and for three months after the end of the study treatment period
  10. Patients volunteered to participate in this study with good compliance and cooperated with multiple blood sample collection and follow-up

Exclusion criteria

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

  1. With other uncontrollable malignancies
  2. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
  3. With any active autoimmune disease or a history of primary immunodeficiency (such as the following, but not limited to: autoimmune hepatitis interstitial pneumonia, uveitis, enteritis, hepatitis, the pituitary gland inflammation, vasculitis, nephritis, thyroid function, thyroid function is reduced, always had thyroid surgery must be incorporated into; Subjects with vitiligo or asthma in complete remission during childhood were included without any intervention as adults)
  4. Patients are taking immunosuppressive or systemic or absorbable topical hormone therapy for immunosuppressive purposes (dose >10mg/day prednisone or other hormone) and continued to be used within 2 weeks before enrolment
  5. Patients with congenital or acquired immune deficiency, such as HIV infection, or active hepatitis (transaminase does not meet the reference, hepatitis B: HBV DNA≥104/ml; hepatitis C: HCV RNA≥103/ml); Chronic hepatitis B virus carriers, HBV DNA\<2000 IU/ml(\<104 copies /ml) and must receive antiviral therapy during the trial to be included in the study
  6. Patients with ≥2 grade pneumonitis from prior chemoradiation therapy
  7. History of psychotropic substance abuse, alcohol abuse or drug abuse
  8. Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
  9. Any condition that, in the opinion of the investigator, would interfere with study results
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • chemoradiotherapy

    Genetic: biomarker detection

Interventions

  • Geneticbiomarker detection

    PBMC and ctDNA analysis

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What researchers measure

Primary outcomes

  1. Biomarkers associated with immune efficacy

    According to the biomarker detection before and after chemoradiotherapy to identify biomarkers related to the immune microenvironment, including the expression levels of NK cells, T cells, B cells and other immune cells reflected by PBMC, as well as the expression levels of ctDNA

    Time frame: up to 2 years

  2. Optimal time for immunotherapy

    Changes in the expression levels of ctDNA and PBMC immune cells before and after chemoradiotherapy to find the optimal time point for immunotherapy

    Time frame: up to 2 years

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Study locations

1 site
  • Hangzhou First People's Hospital
    Hangzhou, Zhejiang 310006, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04749407
Lead sponsor
First People's Hospital of Hangzhou
Responsible party
Sponsor
First posted
Feb 11, 2021
Start date
Feb 2021 (estimated)
Primary completion
Jul 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Feb 11, 2021

Study contacts

Shirong Zhang, Ph.D
Contact
shirley4444@gmail.com
057156007664

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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