An observational study in Lung Adenocarcinoma EGFR-mutated and Leptomeningeal Metastasis From Lung Cancer, sponsored by limeifang. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by limeifang · Observational
Among 88 studies in Adenocarcinoma of Lung with a site in China — 38 open to participants now, 41 under way, 9 of them phase 3. Adenocarcinoma of Lung · China.
Among the 88 studies in Adenocarcinoma of Lung with a site in China, this one is the 30th largest by planned enrollment of the 31 observational ones, is one of 6 that started in 2026, is one of 31 observational ones, reaches primary completion later than 24 of the 40 other live ones, and was the 85th registered.
418 studies on the registry are indexed under Adenocarcinoma of Lung; 79 are open to participants now.
This study's planned enrollment of 74 is below the median of 211 across 90 observational studies indexed under Adenocarcinoma of Lung.
Browse Adenocarcinoma of Lung studies →38 of the 88 studies in Adenocarcinoma of Lung with a site in China are open now, in 12 countries. Each count lists the studies.
Of the 58 Adenocarcinoma of Lung studies recruiting now, 36 (62%) set no upper age limit and 10 (17%) stop at 75 or younger; 4 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →88 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 6 started in 2026.
Median enrollment 69 across the 57 interventional studies, 500 across the 31 observational. Of the 26 that completed or were terminated, 4 (15%) have results posted.
13 of 88 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with limeifang as lead sponsor.
limeifang has 1 study filed under Adenocarcinoma of Lung — fewer than ten, so there is no comparison to draw.
8 of the studies in Adenocarcinoma of Lung with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06634966Phase 3Fudan UniversitySegmentectomy for Solid-dominant Lung Cancer | 2026-12-31 |
| NCT05266846Hunan Province Tumor HospitalPembrolizumab Plus Bevacizumab and Chemotherapy for ALK-rearranged NSCLC With Persistent 5'ALK | 2026-11-16 |
| NCT06730477Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyPlasma Exosomes Reveal the Efficacy of Targeted Therapy in Patients With EGFR Mutation in Lung Adenocarcinoma | 2026-12-30 |
| NCT05191485Sichuan Cancer Hospital and Research InstituteShared Decision Making in Patients With Lung Cancer | 2026-12-31 |
| NCT07647692Peking University People's HospitalDeep Learning Time-Series Prediction of Long-Term Growth Patterns of Pulmonary Ground-Glass Nodules Using Serial CT | 2027-06-01 |
Among the 88 studies in Adenocarcinoma of Lung with a site in China, from their registry updates:
This prospective, multicenter study aims to address the low sensitivity of cerebrospinal fluid (CSF) cytology (60-70%) in diagnosing leptomeningeal metastasis (LM) in patients with EGFR-mutant lung cancer. We will establish a diagnostic methodology and develop a predictive model using surface-enhanced Raman spectroscopy (SERS) technology to improve diagnostic accuracy and guide subsequent clinical management.
Study participants will be recruited from outpatient clinics and inpatient wards across three tertiary hospitals. The target population comprises patients with advanced non-small cell lung cancer (NSCLC) who have been histologically or cytologically confirmed to harbor EGFR-sensitive mutations, and who have leptomeningeal metastasis verified by cerebrospinal fluid (CSF) cytology. Both treatment-naïve patients and those who have undergone prior systemic anti-tumor therapy are eligible. All participants must be aged 18 years or older, have comprehensive clinical records accessible, and voluntarily sign the informed consent form.
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.
Age ≥ 18 years; confirmed NSCLC; EGFR-sensitive mutations (19del, L858R, or uncommon mutations); Positive CSF cytology for malignant cells; No prior treatment or prior systemic therapy allowed; Complete medical records available (demographics, pathology, molecular pathology, imaging); Signed and willingness to complete the study.
Exclusion Criteria:
confirmed mixed histology containing small cell lung cancer (SCLC) components; Presence of other primary other than lung cancer; Molecular pathology indicating concurrent other driver mutations, including ALK, ROS1, or other oncogenic alterations; Co-existing neurological diseases unrelated to the tumor; Severe cardiac or pulmonary dysfunction; Pregnancy or lactation.
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this study, cerebrospinal fluid (CSF) samples are analyzed using surface-enhanced Raman spectroscopy (SERS). SERS is a highly sensitive spectroscopic technique based on nanostructured metallic substrates, capable of capturing characteristic "molecular fingerprint" signals from trace amounts of metabolites, proteins, nucleic acids, and other biomolecules released by tumor cells into the CSF.Detection procedure: CSF specimens are collected from participants via lumbar puncture. After centrifugation, the supernatant is deposited onto a SERS-active substrate, and Raman scattering spectra are acquired under laser excitation. The acquired spectral data undergo preprocessing steps including baseline correction, smoothing, and noise reduction, followed by extraction of characteristic peak information.
SERS signal characteristics and the formation of fingerprint spectra
Time frame: Baseline
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Started Jan 2026 (actual). Primary completion is estimated for Jun 2027, 17 months after the start.
Of 36 observational studies under Adenocarcinoma of Lung, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 65. This study's planned 17 months is below that.
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 active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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