Lung CancerNCT06292052
Relation Between Tumor-draining Lymph Nodes Metastasis Pattern and Non-small Cell Lung Cancer Neoadjuvant Immunotherapy Effectiveness
An observational study of Lung Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this retrospective cohort analysis is to discover the impact of the involvement extent of tumor-draining lymph nodes (TDLNs) in patients who received neoadjuvant immunochemotherapy. The main question it aims to answer is the role of TDLN in the prediction of treatment effectiveness. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Immunotherapy
- How many people
- 209 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 1 Apr 2024
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Patients with resectable NSCLC (clinically staged as T1-4N0-2M0) who underwent neoadjuvant chemoimmunotherapy followed by surgery between January 2017 and January 2024 in Sun Yat-sen University Cancer Center were retrospectively reviewed.
Who may be able to join
- pathologically-confirmed diagnosis of NSCLC by pretreatment biopsy
- clinically staged as T1-4N0-2M0
- having undergo neoadjuvant chemoimmunotherapy
- the agents of immune checkpoint inhibitors (ICIs) belong to PD-1/L1 inhibitors
- having undergo surgery with lymph nodes (LNs) dissection
- having postoperative pathology reports with evaluation of primary tumor and LNs response
- having accessible pretreatment and preoperative radiology examinations imaging or reports
Who cannot join
- using PD-1/L1 inhibitors in the phase of clinical trials
- the agents of neoadjuvant therapy including angiogenesis inhibitors
- having undergone radiotherapy to treat primary tumor or metastatic LNs before surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relation Between Tumor-draining Lymph Nodes Metastasis Pattern and Non-small Cell Lung Cancer Neoadjuvant Immunotherapy Effectiveness: A Retrospective Multi-institutional Cohort Analysis
The goal of this retrospective cohort analysis is to discover the impact of the involvement extent of tumor-draining lymph nodes (TDLNs) in patients who received neoadjuvant immunochemotherapy. The main question it aims to answer is the role of TDLN in the prediction of treatment effectiveness. Researches will compare tumor-draining lymph nodes metastasis (mTDLNs) group and non-draining lymph nodes metastasis (mNDLNs) group to see whether different metastatic patterns of mediastinal lymph nodes can indicate the treatment effectiveness.
- Conditions
- Lung Cancer
- Being tested
- Immunotherapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunotherapyDrug
Also called Chemotherapy
Received neoadjuvant chemotherapy plus immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant immunochemotherapy NSCLC group | NSCLC patients who received neoadjuvant immunochemotherapy and underwent surgery. Receives: Drug: Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete pathologic response
Tumors with 0% viable tumor cells
Measured: through study completion, an average of 3 months
Secondary outcomes (2)
Major pathologic response
Tumors with ≤10% viable tumor cells
Measured: through study completion, an average of 3 months
Complete pathologic response in lymph nodes
Tumors with 0% viable tumor cells in lymph nodes
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Jan 2017
- Primary completion1 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Retrospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangmen Central Hospital, Henan Cancer Hospital
- Responsible party
- Principal investigator, Hao Long, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292052
- Sponsor's protocol ID
- NSCLC-TDLN-001
- Status last verified
- May 2024
- First submitted
- 23 Feb 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will upload to ResMan after publication.
Publications
Rahim MK, Okholm TLH, Jones KB, McCarthy EE, Liu CC, Yee JL, Tamaki SJ, Marquez DM, Tenvooren I, Wai K, Cheung A, Davidson BR, Johri V, Samad B, O'Gorman WE, Krummel MF, van Zante A, Combes AJ, Angelo M, Fong L, Algazi AP, Ha P, Spitzer MH. Dynamic CD8+ T cell responses to cancer immunotherapy in human regional lymph nodes are disrupted in metastatic lymph nodes. Cell. 2023 Mar 16;186(6):1127-1143.e18. doi: 10.1016/j.cell.2023.02.021.
PubMed 36931243Prokhnevska N, Cardenas MA, Valanparambil RM, Sobierajska E, Barwick BG, Jansen C, Reyes Moon A, Gregorova P, delBalzo L, Greenwald R, Bilen MA, Alemozaffar M, Joshi S, Cimmino C, Larsen C, Master V, Sanda M, Kissick H. CD8+ T cell activation in cancer comprises an initial activation phase in lymph nodes followed by effector differentiation within the tumor. Immunity. 2023 Jan 10;56(1):107-124.e5. doi: 10.1016/j.immuni.2022.12.002. Epub 2022 Dec 28.
PubMed 36580918
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Tumor-draining Lymph Nodes Metastasis Pattern and Non-small Cell Lung Cancer Neoadjuvant Immunotherapy Effectiveness: A Retrospective Multi-institutional Cohort Analysis
- ClinicalTrials.gov ID
- NCT06292052
- Acronym / sponsor ID
- NSCLC-TDLN-001
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Jiangmen Central Hospital, Henan Cancer Hospital
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 4 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.
The goal of this retrospective cohort analysis is to discover the impact of the involvement extent of tumor-draining lymph nodes (TDLNs) in patients who received neoadjuvant immunochemotherapy. The main question it aims to answer is the role of TDLN in the prediction of treatment effectiveness. Researches will compare tumor-draining lymph nodes metastasis (mTDLNs) group and non-draining lymph nodes metastasis (mNDLNs) group to see whether different metastatic patterns of mediastinal lymph nodes can indicate the treatment effectiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant immunochemotherapy NSCLC group | – | Drug: ImmunotherapyNSCLC patients who received neoadjuvant immunochemotherapy and underwent surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with resectable NSCLC (clinically staged as T1-4N0-2M0) who underwent neoadjuvant chemoimmunotherapy followed by surgery between January 2017 and January 2024 in Sun Yat-sen University Cancer Center were retrospectively reviewed.
Key inclusion criteria (7 listed)
- pathologically-confirmed diagnosis of NSCLC by pretreatment biopsy
- clinically staged as T1-4N0-2M0
- having undergo neoadjuvant chemoimmunotherapy
- the agents of immune checkpoint inhibitors (ICIs) belong to PD-1/L1 inhibitors
- having undergo surgery with lymph nodes (LNs) dissection
Key exclusion criteria (3 listed)
- using PD-1/L1 inhibitors in the phase of clinical trials
- the agents of neoadjuvant therapy including angiogenesis inhibitors
- having undergone radiotherapy to treat primary tumor or metastatic LNs before surgery
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 |
|---|---|---|
| ImmunotherapyAlso: ChemotherapyReceived neoadjuvant chemotherapy plus immunotherapy | Drug | Neoadjuvant immunochemotherapy NSCLC group |
Primary outcome
Complete pathologic response
Time frame: through study completion, an average of 3 months
Tumors with 0% viable tumor cells
2 secondary outcomes
Major pathologic response
Time frame: through study completion, an average of 3 months
Complete pathologic response in lymph nodes
Time frame: through study completion, an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Results publication: PubMed 36931243Rahim MK, Okholm TLH, Jones KB, McCarthy EE, Liu CC, Yee JL, Tamaki SJ, Marquez DM, Tenvooren I, Wai K, Cheung A, Davidson BR, Johri V, Samad B, O'Gorman WE, Krummel MF, van Zante A, Combes AJ, Angelo M, Fong L, Algazi AP, Ha P, Spitzer MH. Dynamic CD8+ T cell responses to cancer immunotherapy in human regional lymph nodes are disrupted in metastatic lymph nodes. Cell. 2023 Mar 16;186(6):1127-1143.e18. doi: 10.1016/j.cell.2023.02.021.
- Results publication: PubMed 36580918Prokhnevska N, Cardenas MA, Valanparambil RM, Sobierajska E, Barwick BG, Jansen C, Reyes Moon A, Gregorova P, delBalzo L, Greenwald R, Bilen MA, Alemozaffar M, Joshi S, Cimmino C, Larsen C, Master V, Sanda M, Kissick H. CD8+ T cell activation in cancer comprises an initial activation phase in lymph nodes followed by effector differentiation within the tumor. Immunity. 2023 Jan 10;56(1):107-124.e5. doi: 10.1016/j.immuni.2022.12.002. Epub 2022 Dec 28.
- Individual participant dataSharing planned: Undecided. The data will upload to ResMan after publication.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lung Cancer, run by Sun Yat-sen University 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 14 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete pathologic response (time frame: through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06292052, which also lists 2 linked publications.
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 14 May 2024; AzTrials last refreshed its copy on 29 Oct 2026.