Locally Advanced Non-small Cell Lung CancerNCT06287320
The Predictive Biomarkers in Patients With Locally Advanced Non-small Cell Lung Cancer
An observational study of Locally Advanced Non-small Cell Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study is a prospective cohort study to evaluate the peripheral blood lymphocyte subsets as predicative biomarkers reflecting the efficacy and toxicity in patients with locally advanced non-small cell lung cancer (NSCLC) received chemoradiotherapy (CRT) with or without immune checkpoint inhibitors (ICIs). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Non-small Cell Lung Cancer
- What is being tested?
- concurrent or sequential chemoradiotherapy and Immunotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 28 Feb 2026
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Consecutive locally advanced NSCLC patients treated with definitive CRT with or without ICIs at hospital.
Who may be able to join
- Age 18-75 years; ECOG score 0-2.
- Pathologically confirmed locally advanced NSCLC according to the 8th AJCC staging system.
- Received definitive radiotherapy, concurrently or sequentially combined with platinum-based doublet chemotherapy.
- No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function.
Who cannot join
- Pathologic type was adenocarcinoma with EGFR gene mutation or ALK gene rearrangement.
- Patients with other active malignancies within 5 years or at the same time.
- Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease, diverticulitis [except diverticular disease], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener' s syndrome).
- History of allogeneic organ transplantation.
- History of active primary immunodeficiency.
- Patients with uncontrolled concurrent diseases, including but not limited to persistent or active infection (including tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea or mental illness.
- Women of child-bearing potential who are pregnant or breastfeeding.
- The investigator judged other situations not suitable for inclusion in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Science and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Nan Bi, MD, PhD, binan_email@163.com
About this study
Official title: The Peripheral Blood Lymphocyte Subsets as Predicative Biomarkers Reflecting the Efficacy and Toxicity in Patients With Locally Advanced Non-small Cell Lung Cancer Received Chemoradiotherapy With or Without Immunotherapy
This study is a prospective cohort study to evaluate the peripheral blood lymphocyte subsets as predicative biomarkers reflecting the efficacy and toxicity in patients with locally advanced non-small cell lung cancer (NSCLC) received chemoradiotherapy (CRT) with or without immune checkpoint inhibitors (ICIs).
Read the detailed description
All patients had a pathologically confirmed locally advanced NSCLC according to the 8th AJCC staging system and received definitive radiotherapy, concurrently or sequentially combined with platinum-based doublet chemotherapy. The peripheral blood samples at various time points including before radiation, 4 weeks after beginning of radiation, the end of radiation, 1 month post radiation, and 1 month post consolidation immunotherapy were collected for lymphocyte subsets detection.
The subjects will be divided into two groups according to whether patients received ICIs, namely, NSCLC patients received CRT plus ICIs and NSCLC patients received CRT.
- Being tested
- concurrent or sequential chemoradiotherapy, Immunotherapy
- Keywords
- Peripheral blood lymphocyte subsets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concurrent or sequential chemoradiotherapyRadiation
Thoracic radiation therapy(with the prescribed dose of 50-70 Gy), concurrently or sequentially combined with platinum-based doublet chemotherapy.
ImmunotherapyDrug
anti-PD-1/anti-PD-L1 immune checkpoint inhibitors
| Study group | Role | What they receive |
|---|---|---|
| NSCLC patients received CRT plus ICIs | For it's an observational study, locally advanced NSCLC patients received CRT with induction immunotherapy or consolidation immunotherapy will be divided into the group "NSCLC patients received CRT plus ICIs". Receives: Radiation: concurrent or sequential chemoradiotherapy; Drug: Immunotherapy | |
| NSCLC patients received CRT | For it's an observational study, locally advanced NSCLC patients received CRT without immunotherapy will be divided into the group "NSCLC patients received CRT". Receives: Radiation: concurrent or sequential chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
The incidence of adverse events (AEs) and serious adverse events (SAEs) is evaluated by CTCAE 5.0. Appropriate description of AEs and laboratory data/vital signs will be produced. Number of patients who had at least one adverse event will be calculated.
Measured: AEs and SAEs must be collected from the start of treatment to 28 days after discontinuation of study drug, up to 24 months.
Secondary outcomes (4)
Progression-free survival (PFS)
Defined as the time from date of first treatment until the date of first documented progression or date of death from any cause, whichever came first.
Measured: From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Overall survival (OS)
Defined as the time from the date of first treatment to the date of any documented death due to any cause.
Measured: From the date of first treatment to the date of any documented death due to any cause, assessed up to 24 months.
Objective Response Rate (ORR)
The objective response rate (ORR) will be calculated as the number of patients with CR or PR per RECIST Criteria.
Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: Tumor assessment using RECIST will be performed at baseline then every 3 months from the first treatment until objective progression or death from any cause, assessed up to 24 months.
Disease control rate (DCR)
DCR will be calculated as the number of patients with CR, PR or sustained SD≥6 weeks per RECIST Criteria.
Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase.
Measured: Tumour assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nan Bi, MD, Principal investigator, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287320
- Sponsor's protocol ID
- Bioplc
- Status last verified
- Jan 2024
- First submitted
- 23 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Peripheral Blood Lymphocyte Subsets as Predicative Biomarkers Reflecting the Efficacy and Toxicity in Patients With Locally Advanced Non-small Cell Lung Cancer Received Chemoradiotherapy With or Without Immunotherapy
- ClinicalTrials.gov ID
- NCT06287320
- Acronym / sponsor ID
- Bioplc
- Keywords
- Peripheral blood lymphocyte subsets
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 1 Mar 2024 (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 is a prospective cohort study to evaluate the peripheral blood lymphocyte subsets as predicative biomarkers reflecting the efficacy and toxicity in patients with locally advanced non-small cell lung cancer (NSCLC) received chemoradiotherapy (CRT) with or without immune checkpoint inhibitors (ICIs).
Detailed description
All patients had a pathologically confirmed locally advanced NSCLC according to the 8th AJCC staging system and received definitive radiotherapy, concurrently or sequentially combined with platinum-based doublet chemotherapy. The peripheral blood samples at various time points including before radiation, 4 weeks after beginning of radiation, the end of radiation, 1 month post radiation, and 1 month post consolidation immunotherapy were collected for lymphocyte subsets detection.
The subjects will be divided into two groups according to whether patients received ICIs, namely, NSCLC patients received CRT plus ICIs and NSCLC patients received CRT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSCLC patients received CRT plus ICIs | – | Radiation: concurrent or sequential chemoradiotherapy, Drug: ImmunotherapyFor it's an observational study, locally advanced NSCLC patients received CRT with induction immunotherapy or consolidation immunotherapy will be divided into the group "NSCLC patients received CRT plus ICIs". |
| NSCLC patients received CRT | – | Radiation: concurrent or sequential chemoradiotherapyFor it's an observational study, locally advanced NSCLC patients received CRT without immunotherapy will be divided into the group "NSCLC patients received CRT". |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive locally advanced NSCLC patients treated with definitive CRT with or without ICIs at hospital.
Key inclusion criteria (4 listed)
- Age 18-75 years; ECOG score 0-2.
- Pathologically confirmed locally advanced NSCLC according to the 8th AJCC staging system.
- Received definitive radiotherapy, concurrently or sequentially combined with platinum-based doublet chemotherapy.
- No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function.
Key exclusion criteria (8 listed)
- Pathologic type was adenocarcinoma with EGFR gene mutation or ALK gene rearrangement.
- Patients with other active malignancies within 5 years or at the same time.
- Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease, diverticulitis [except diverticular disease], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener' s syndrome).
- History of allogeneic organ transplantation.
- History of active primary immunodeficiency.
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 |
|---|---|---|
| concurrent or sequential chemoradiotherapyThoracic radiation therapy(with the prescribed dose of 50-70 Gy), concurrently or sequentially combined with platinum-based doublet chemotherapy. | Radiation | NSCLC patients received CRT, NSCLC patients received CRT plus ICIs |
| Immunotherapyanti-PD-1/anti-PD-L1 immune checkpoint inhibitors | Drug | NSCLC patients received CRT plus ICIs |
Primary outcome
Adverse Event
Time frame: AEs and SAEs must be collected from the start of treatment to 28 days after discontinuation of study drug, up to 24 months.
The incidence of adverse events (AEs) and serious adverse events (SAEs) is evaluated by CTCAE 5.0. Appropriate description of AEs and laboratory data/vital signs will be produced. Number of patients who had at least one adverse event will be calculated.
4 secondary outcomes
Progression-free survival (PFS)
Time frame: From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Overall survival (OS)
Time frame: From the date of first treatment to the date of any documented death due to any cause, assessed up to 24 months.
Objective Response Rate (ORR)
Time frame: Tumor assessment using RECIST will be performed at baseline then every 3 months from the first treatment until objective progression or death from any cause, assessed up to 24 months.
Disease control rate (DCR)
Time frame: Tumour assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Nan Bi, MD principal investigator
Chinese Academy of Medical Sciences and Peking Union Medical College
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 Locally Advanced Non-small Cell Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 4 inclusion and 8 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 1 Mar 2024. 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 Nan Bi, MD (8601087788799, binan_email@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (time frame: AEs and SAEs must be collected from the start of treatment to 28 days after discontinuation of study drug, up to 24 months.). 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 1 Mar 2024.