Non-small Cell Lung Cancer Stage IIINCT04749407
Biomarkers of Stage III Locally Advanced Unresectable Non-small-cell Lung Cancer
An observational study of Non-small Cell Lung Cancer Stage III, run by First People's Hospital of Hangzhou at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-small Cell Lung Cancer Stage III
- What is being tested?
- biomarker detection
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Feb 2021to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Stage III locally advanced unresectable Non-small cell lung cancer (NSCLC)
Who may be able to join
- Provision of signed, written and dated informed consent prior to any study specific procedures
- Male or female aged over 18 years and under 70 years
- 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
- With measurable lesions (according to RECIST 1.1 criteria, long diameter of tumor lesions is 10mm, short diameter of lymph node lesions is 15mm).
- World Health Organization (WHO) Performance Status of 0~2
- Life expectancy ≥6 months
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- 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
- 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
- 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
- Patients volunteered to participate in this study with good compliance and cooperated with multiple blood sample collection and follow-up
Who cannot join
- Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- With other uncontrollable malignancies
- Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
- 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)
- 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
- 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
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- Patients with ≥2 grade pneumonitis from prior chemoradiation therapy
- History of psychotropic substance abuse, alcohol abuse or drug abuse
- 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
- Any condition that, in the opinion of the investigator, would interfere with study results
Trial locations and contacts
1 site in 1 country.
China1 site
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006
Shirong Zhang, Dr., 057156007650, shirley4444@gmail.com
About this study
Official title: Dynamic Biomarkers of Immune Microenvironment for Stage III Locally Advanced Unresectable Non-small-cell Lung Cancer
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.
- Conditions
- Non-small Cell Lung Cancer Stage III
- Being tested
- biomarker detection
- Keywords
- stage III locally advanced unresectable non-small-cell lung cancer, circulating tumor DNA, peripheral blood mononuclear cells
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biomarker detectionGenetic
PBMC and ctDNA analysis
| Study group | Role | What they receive |
|---|---|---|
| chemoradiotherapy | Not described Receives: Genetic: biomarker detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 2 years
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
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study startFeb 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer Stage IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749407
- Sponsor's protocol ID
- HZCH-2021-02
- Status last verified
- Feb 2021
- First submitted
- 7 Feb 2021
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Biomarkers of Immune Microenvironment for Stage III Locally Advanced Unresectable Non-small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04749407
- Acronym / sponsor ID
- HZCH-2021-02
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chemoradiotherapy | – | Genetic: biomarker detection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Stage III locally advanced unresectable Non-small cell lung cancer (NSCLC)
Key inclusion criteria (11 listed)
- Provision of signed, written and dated informed consent prior to any study specific procedures
- Male or female aged over 18 years and under 70 years
- 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
- With measurable lesions (according to RECIST 1.1 criteria, long diameter of tumor lesions is 10mm, short diameter of lymph node lesions is 15mm).
- World Health Organization (WHO) Performance Status of 0~2
Key exclusion criteria (10 listed)
- Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- With other uncontrollable malignancies
- Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biomarker detectionPBMC and ctDNA analysis | Genetic | chemoradiotherapy |
Primary outcome
Biomarkers associated with immune efficacy
Time frame: up to 2 years
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
Optimal time for immunotherapy
Time frame: up to 2 years
Changes in the expression levels of ctDNA and PBMC immune cells before and after chemoradiotherapy to find the optimal time point for immunotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer Stage III, run by First People's Hospital of Hangzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shirong Zhang, Ph.D (057156007664, shirley4444@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers associated with immune efficacy (time frame: up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.