Relation Between Tumor-draining Lymph Nodes Metastasis Pattern and Non-small Cell Lung Cancer Neoadjuvant Immunotherapy Effectiveness

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06292052
• Other study ID #: NSCLC-TDLN-001
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: April 1, 2024

Study information

• Verified date: May 2024
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: April 1, 2024
• Est. primary completion date: March 1, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Lymphatic Metastasis

Intervention

Drug:
• Immunotherapy
Received neoadjuvant chemotherapy plus immunotherapy

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-sen University	Henan Cancer Hospital, Jiangmen Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Prokhnevska 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 co — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete pathologic response	Tumors with 0% viable tumor cells	through study completion, an average of 3 months
Secondary	Major pathologic response	Tumors with =10% viable tumor cells	through study completion, an average of 3 months
Secondary	Complete pathologic response in lymph nodes	Tumors with 0% viable tumor cells in lymph nodes	through study completion, an average of 3 months