Non-Small Cell Lung CancerNCT07119190
A Perioperative Comprehensive Diagnosis and Treatment System for Lung Cancer in the Era of Neoadjuvant Immunotherapy
An observational study of Non-Small Cell Lung Cancer, run by Peking University People's Hospital.
Trial summary
The goal of this study is to develop and refine an integrated minimally invasive care pathway for resectable lung cancer in the immunotherapy era, establishing a novel precision perioperative immunotherapy paradigm encompassing original techniques and clinical applications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 6 Aug 2025to 30 Oct 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who meet the eligibility criteria will be included consecutively
Who may be able to join
- Age ≥ 18 years old;
- NSCLC patients underwent radical surgical resection;
- Adequate clinical-pathologic data, imaging data and follow-up data obtainable for multi-omics analysis;
- Scheduled for or currently receiving neoadjuvant/perioperative immunotherapy.
Who cannot join
- Histology of other malignant tumors, including concurrent malignant tumors of other organ systems;
- Unresectable advanced disease (Stage IV) or locally advanced unresectable (Stage IIIC);
- Pregnancy or lactation;
- Insufficient sample quality;
- Severe organ dysfunction (e.g. cardiac or renal insufficiency);
- Other judgments by the Investigator that the patient should not participate in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Construction of a Perioperative Comprehensive Diagnosis and Treatment System for Lung Cancer in the Era of Neoadjuvant Immunotherapy
The goal of this study is to develop and refine an integrated minimally invasive care pathway for resectable lung cancer in the immunotherapy era, establishing a novel precision perioperative immunotherapy paradigm encompassing original techniques and clinical applications.
Read the detailed description
Lung cancer remains the leading cause of cancer-related mortality in China and globally, imposing a substantial disease burden on society. Although comprehensive treatment strategies centered on surgery have improved patient outcomes, and perioperative immunotherapy-particularly immune checkpoint inhibitors-has profoundly reshaped the therapeutic landscape, significant knowledge gaps and critical challenges persist in this field. These challenges include uncertain beneficiary populations, poorly understood immune mechanisms, inaccurate efficacy prediction, difficult determination of resection margins, controversial efficacy assessment, and lack of effective early warning for adverse reactions.
This study will systematically identify biomarkers for early diagnosis and recurrence monitoring through multi-omic analysis of peripheral blood immune cell subsets and non-invasive liquid biopsies; investigate the tumor immune microenvironment's role in immunotherapy response mechanisms and predict treatment efficacy via multi-omic studies of tissue specimens; develop novel AI- and radiomics-assisted pathological assessment systems and prognostic prediction models; implement perioperative symptom assessment for timely identification of immune-related adverse events (irAEs) while conducting prehabilitation training for perioperative nursing care.
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, Multiomics analysis, Tumor immune microenvironment, Radiomics, Pathological response, Immune-related adverse event, Nursing prehabilitation
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | Non-small cell Lung cancer patients receiving neoadjuvant immunotherapy and surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
Pathologic Complete Response (pCR) is defined as the absence of residual tumor in both the primary lung tumor site and all sampled regional lymph nodes after neoadjuvant immunotherapy, confirmed through systematic pathological examination of the surgical specimen.
Measured: At surgery (typically 3-6 months post-treatment initiation)
Secondary outcomes (8)
Major Pathological Response (MPR)
Major Pathologic Response (MPR) is defined as the presence of ≤10% residual viable tumor cells in both the primary lung tumor site and sampled regional lymph nodes after neoadjuvant immunotherapy, confirmed through systematic pathological examination of the surgical specimen.
Measured: At surgery (typically 3-6 months post-treatment initiation)
Objective Response Rate (ORR)
ORR is defined as the proportion of patients achieving either a complete response (CR; disappearance of all target lesions) or partial response (PR; ≥30% reduction in the sum of target lesion diameters) during or after neoadjuvant immunotherapy, as assessed by serial imaging (CT/PET-CT) using iRECIST criteria.
Measured: After two cycles or four cycles of neoadjuvant therapy (each cycle is 21 days).
Recurrence-free Survival (RFS)
Time from randomization to disease recurrence or death from any cause.
Measured: Through study completion, an average of 2 years
Overall Survival (OS)
Time from randomization to death from any cause.
Measured: Through study completion, an average of 2 years
MRD (minimal residual disease) dynamics after neoadjuvant immunotherapy
Postoperative dynamics of ctDNA-based MRD and timely detection of recurrence or metastasis in lung cancer patients receiving neoadjuvant immunotherapy.
Measured: Periprocedural and every three to six months post-treatment (up to three years)
Symptom Severity Score
Assessment of perioperative symptom burden (e.g., pain, fatigue) using validated scales like the MDASI-C (M. D. Anderson Symptom Inventory) for lung cancer patients.
Measured: Preoperative (T1: 2-4 weeks pre-surgery), postoperative (e.g., T3: 12-24 hours post-surgery, T5: 30 days post-surgery), and up to 90 days post-surgery.
Immune-Related Adverse Event (irAE) Incidence
Frequency and severity of adverse events (e.g., rash, colitis) related to immunotherapy, graded using standardized criteria like CTCAE (Common Terminology Criteria for Adverse Events).
Measured: Periprocedural and up to 6 months post-treatment.
Changes in PD-L1 expression (TPS) and TIL subpopulations (CD8+/FOXP3+ ratios, et al) before and after neoadjuvant immunotherapy
PD-L1 expression (22C3 pharmDx assay; TPS ≥1% cutoff), multiplex immunofluorescence (CD8: clone C8/144B; FOXP3: clone 236A/E7) and multomoics analyses were performed on paired pre-/post-NAD biopsies.
Measured: Periprocedural.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start6 Aug 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Oct 2027 (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 CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- 350 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Health Commission
- Responsible party
- Principal investigator, Yang Fan, MD, Peking University People's Hospital
- Investigators
- Fan Yang, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119190
- Sponsor's protocol ID
- BRWEP2024W034080200
- Status last verified
- Aug 2025
- First submitted
- 15 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Perioperative Comprehensive Diagnosis and Treatment System for Lung Cancer in the Era of Neoadjuvant Immunotherapy
- ClinicalTrials.gov ID
- NCT07119190
- Acronym / sponsor ID
- BRWEP2024W034080200
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, Multiomics analysis, Tumor immune microenvironment, Radiomics, Pathological response, Immune-related adverse event, Nursing prehabilitation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Beijing Municipal Health Commission
- Study start
- 6 Aug 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 12 Aug 2025 (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.
The goal of this study is to develop and refine an integrated minimally invasive care pathway for resectable lung cancer in the immunotherapy era, establishing a novel precision perioperative immunotherapy paradigm encompassing original techniques and clinical applications.
Detailed description
Lung cancer remains the leading cause of cancer-related mortality in China and globally, imposing a substantial disease burden on society. Although comprehensive treatment strategies centered on surgery have improved patient outcomes, and perioperative immunotherapy-particularly immune checkpoint inhibitors-has profoundly reshaped the therapeutic landscape, significant knowledge gaps and critical challenges persist in this field. These challenges include uncertain beneficiary populations, poorly understood immune mechanisms, inaccurate efficacy prediction, difficult determination of resection margins, controversial efficacy assessment, and lack of effective early warning for adverse reactions.
This study will systematically identify biomarkers for early diagnosis and recurrence monitoring through multi-omic analysis of peripheral blood immune cell subsets and non-invasive liquid biopsies; investigate the tumor immune microenvironment's role in immunotherapy response mechanisms and predict treatment efficacy via multi-omic studies of tissue specimens; develop novel AI- and radiomics-assisted pathological assessment systems and prognostic prediction models; implement perioperative symptom assessment for timely identification of immune-related adverse events (irAEs) while conducting prehabilitation training for perioperative nursing care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | – | –Non-small cell Lung cancer patients receiving neoadjuvant immunotherapy and surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet the eligibility criteria will be included consecutively
Key inclusion criteria (4 listed)
- Age ≥ 18 years old;
- NSCLC patients underwent radical surgical resection;
- Adequate clinical-pathologic data, imaging data and follow-up data obtainable for multi-omics analysis;
- Scheduled for or currently receiving neoadjuvant/perioperative immunotherapy.
Key exclusion criteria (6 listed)
- Histology of other malignant tumors, including concurrent malignant tumors of other organ systems;
- Unresectable advanced disease (Stage IV) or locally advanced unresectable (Stage IIIC);
- Pregnancy or lactation;
- Insufficient sample quality;
- Severe organ dysfunction (e.g. cardiac or renal insufficiency);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pathological Complete Response (pCR)
Time frame: At surgery (typically 3-6 months post-treatment initiation)
Pathologic Complete Response (pCR) is defined as the absence of residual tumor in both the primary lung tumor site and all sampled regional lymph nodes after neoadjuvant immunotherapy, confirmed through systematic pathological examination of the surgical specimen.
8 secondary outcomes
Major Pathological Response (MPR)
Time frame: At surgery (typically 3-6 months post-treatment initiation)
Objective Response Rate (ORR)
Time frame: After two cycles or four cycles of neoadjuvant therapy (each cycle is 21 days).
Recurrence-free Survival (RFS)
Time frame: Through study completion, an average of 2 years
Overall Survival (OS)
Time frame: Through study completion, an average of 2 years
MRD (minimal residual disease) dynamics after neoadjuvant immunotherapy
Time frame: Periprocedural and every three to six months post-treatment (up to three years)
Symptom Severity Score
Time frame: Preoperative (T1: 2-4 weeks pre-surgery), postoperative (e.g., T3: 12-24 hours post-surgery, T5: 30 days post-surgery), and up to 90 days post-surgery.
Immune-Related Adverse Event (irAE) Incidence
Time frame: Periprocedural and up to 6 months post-treatment.
Changes in PD-L1 expression (TPS) and TIL subpopulations (CD8+/FOXP3+ ratios, et al) before and after neoadjuvant immunotherapy
Time frame: Periprocedural.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Fan Yang, MD principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Peking University People's Hospital.
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 6 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: opening soon, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Li, MD (+86 13051713494, lihao_pkuhsc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: At surgery (typically 3-6 months post-treatment initiation)). 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 12 Aug 2025.