An observational study in Solid Neoplasms and Non-Small Cell Lung Cancer, sponsored by Shengjing Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Shengjing Hospital · Observational
Among 1,877 studies in Carcinoma, Non-Small-Cell Lung with a site in China — 764 open to participants now, 986 under way, 202 of them phase 3. Carcinoma, Non-Small-Cell Lung · China.
Among the 1,877 studies in Carcinoma, Non-Small-Cell Lung with a site in China, this one is the 50th largest by enrollment of the 286 observational ones, is one of 119 that started in 2019, is one of 286 observational ones, and was the 1,876th registered.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's enrollment of 900 is above the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →764 of the 1,877 studies in Carcinoma, Non-Small-Cell Lung with a site in China are open now, in 12 countries. Each count lists the studies.
Of the 1,324 Carcinoma, Non-Small-Cell Lung studies recruiting now, 986 (74%) set no upper age limit and 226 (17%) stop at 75 or younger; 34 take children under 18; 39 take healthy volunteers.
This study: 18 Years to 79 Years · all sexes · no healthy volunteers.
The full table on the hub →1,877 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 119 started in 2019.
Median enrollment 100 across the 1,591 interventional studies, 200 across the 286 observational. Of the 452 that completed or were terminated, 130 (29%) have results posted.
803 of 1,877 have an industry lead sponsor. The 10 most frequent:
Shengjing Hospital is the lead sponsor of 127 studies on the registry; 59 are open to participants now.
Shengjing Hospital has 1 study filed under Carcinoma, Non-Small-Cell Lung — fewer than ten, so there is no comparison to draw.
228 of the studies in Carcinoma, Non-Small-Cell Lung with a site in China that are under way reach primary completion within a year, 33 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06448312Phase 3Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer | 2026-11 |
| NCT06704620Phase 3Tianjin Medical University Cancer Institute and HospitalStudy of Tislelizumab and Platinum-based Chemotherapy Combination With H1 Receptor Antagonist（Diphenhydramine）in Advanced and Metastatic Non-Small Cell Lung Cancer | 2026-11 |
| NCT05429463Phase 3Second Affiliated Hospital, Zhejiang University, School of MedicineNeoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC（neoSCORE Ⅱ） | 2026-11-30 |
| NCT06711900Phase 3Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.A Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer | 2026-12 |
| NCT06382129Phase 3Sichuan Baili Pharmaceutical Co., Ltd.A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer(PANKU-Lung02) | 2026-12 |
Among the 1,877 studies in Carcinoma, Non-Small-Cell Lung with a site in China, from their registry updates:
Background \& Rationale: Intratumoral heterogeneity (ITH) is a recognized hallmark and critical driver of therapeutic resistance, rapid disease progression, and poor survival across solid malignancies, notably advanced non-small-cell lung cancer (NSCLC). While tissue biopsies provide histopathologic confirmation, they are invasive and subject to severe spatial sampling bias. Standard whole-tumor radiomics from single-modality CT often masks localized subregional ecological niches. 18F-FDG PET/CT unites glucose metabolic activity with anatomical resolution, offering an ideal non-invasive tool to map whole-tumor spatial and functional heterogeneity in vivo.
Methods \& Design: In this multicenter, bidirectional (retrospective and prospective) observational cohort study, 900 advanced NSCLC patients receiving first-line systemic therapies (chemotherapy, anti-PD-1 immunotherapy, and EGFR-TKIs) were enrolled. Baseline 18F-FDG PET/CT scans obtained within 2 weeks prior to therapy were partitioned into distinct biological habitats using entropy-intensity clustering. IBSI-compliant radiomic features were extracted to develop treatment-specific imaging intratumoral heterogeneity (IITH) signatures. Diagnostic accuracy for staging/metastases and prognostic performance for 6-month progression status, progression-free survival (PFS), and overall survival (OS) were comprehensively validated across internal, external multicenter, and independent prospective cohorts, with biological explainability benchmarked against digital histopathology (HoVer-Net nuclear morphometrics) and transcriptomics.
This cohort study employs an ambispective design, with both retrospective and prospective phases.
The study population is recruited from multiple large tertiary general hospitals and specialized cancer centers including Shengjing Hospital of China Medical University and Liaoning Cancer Hospital. Eligible patients are pathologically confirmed and receive standardized first-line systemic therapy for solid tumors / non-small cell lung cancer. This consecutive lung cancer cohort reflects real-world clinical populations across multiple centers in Northeast China.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: This is an observational study with no intervention.
Other: This is an observational study with no intervention.
Other: This is an observational study with no intervention.
This is an observational study with no intervention.
6-Month Progression-Free Survival [PFS] Status
Based on the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), the risk probability score derived from the baseline 18F-FDG PET/CT multimodal intratumoral heterogeneity model is adopted to predict the binary endpoint of disease progression (PD) or all-cause death within 6 months after patients receive first-line systemic anti-tumor therapy. This binary endpoint evaluates 6 months PFS status in patients.
Time frame: Baseline to 6 months post-treatment initiation
Progression-Free Survival
Defined as the time interval from the initiation of first-line systemic anti-tumor therapy to the first documented objective disease progression (per RECIST v1.1) or all-cause death. Kaplan-Meier method will be used to plot survival curves. Log-rank test and multivariate Cox proportional hazards regression model will be applied to evaluate the independent prognostic hazard ratio (HR with 95% confidence interval) and C-index (concordance index) of the PET/CT heterogeneity score.
Time frame: Baseline to progression or death, up to 36 months
Overall Survival
Defined as the time interval from the date of histopathologically confirmed tumor diagnosis to all-cause death. The independent predictive performance of the PET/CT multimodal model for long-term all-cause mortality risk will be assessed.
Time frame: Up to 60 months
Diagnostic Accuracy for Nodal and Distant Metastases
Metastasis diagnosis description: Using histopathological biopsy or long-term multimodality imaging combined with follow-up as the reference standard, we will evaluate the diagnostic sensitivity, specificity and area under the ROC curve of baseline PET/CT multimodal metabolic and anatomical features for regional mediastinal lymph node metastasis (N staging) and occult distant organ metastasis (M staging).
Time frame: within 3 months from baseline to post-treatment initiation
Objective Response Rate
The proportion of patients achieving best objective response (complete response \[CR\] + partial response \[PR\]) and disease control (CR + PR + stable disease \[SD\]) during first-line treatment will be assessed according to RECIST v1.1. The correlation between baseline PET/CT metabolic heterogeneity and short-term treatment response will be analyzed.
Time frame: From treatment initiation to the assessment of best treatment response (usually 2-6 cycles after treatment initiation, approximately 6-18 weeks).
Disease Control Rate
The proportion of patients achieving best objective response (complete response \[CR\] + partial response \[PR\]) and disease control (CR + PR + stable disease \[SD\]) during first-line treatment will be assessed according to RECIST v1.1. The correlation between baseline PET/CT metabolic heterogeneity and short-term treatment response will be analyzed.
Time frame: From treatment initiation to the assessment of best treatment response (usually 2-6 cycles after treatment initiation, approximately 6-18 weeks).
Ran from Feb 2019 to primary completion in Dec 2023, 58 months.
Of 355 non-industry observational studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 126. This study's 58 months is close to that.
Counting every sponsor, half of 497 studies reached it within 55 months; a quarter within 35 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →