Mechanism Study to Investigate Difference in Efficacy of Neoadjuvant Chemoimmunotherapy in Lung Squamous Cell Carcinoma

A Mechanism Study to Investigate the Difference in Efficacy of Neoadjuvant PD-1 Blockade Combined With Chemotherapy in the Treatment of IIA-IIIB Stage Lung Squamous Cell Carcinoma

To explore mechanisms of immunotherapy resistance and relation to changes in the TME before and after PD-1 blockade combined with chemotherapy

Study Overview

• Status: Recruiting
• Conditions: Lung Squamous Cell Carcinoma; Neoadjuvant Chemoimmunotherapy; Tumor Microenvironment
• Intervention / Treatment: Other: Pathological response assessment

Detailed Description

The biobank of thoracic surgery department of Tangdu Hospital collected pre-treatment tissues from patients during endoscopy. The investigators retrospectively summarized the clinical characteristics of these patients and patients with operable locally advanced lung squamous cell carcinoma were selected and followed.

The investigators plan to employ snRNA-seq and scRNA-seq respectively to profile 20 samples of paired pre-treatment and post-treatment tumors from ten patients (discovery cohort) to create a cell atlas for analysis, and spatial transcriptomics to examine 8 samples from four patients. In discovery cohort, estimated 5 patients achieve major pathological response (MPR) and 5 patients achieve non-MPR after NICB.

After analyzing the results of discovery cohort, the investigators will collect frozen tissues and formalin-fixed, paraffin-embedded (FFPE) tissue from our biobank for bulk RNA-seq analysis or immunohistochemistry (IHC) staining as validation cohort to further investigate the predictive value and biological significance of our markers.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710038
      • Recruiting
      • Hongtao Duan
      • Contact: Hongtao Duan, Dr.; Phone Number: 02984717569; Email: 646014852@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients enrolled in this study had histologically confirmed LUSC with operable locally advanced stage, no prior anti-tumor therapy, and received neoadjuvant immunotherapy consisting of three cycles of anti-PD-1 ICB plus nab-paclitaxel and carboplatin

Description

Inclusion Criteria:

1. aged 40 to 80 years;
2. had histologically confirmed LUSC with operable locally advanced stage
3. no prior anti-tumor therapy; received neoadjuvant immunotherapy consisting of three cycles of anti-PD-1 ICB plus nab-paclitaxel and carboplatin
4. pre-treatment tissues

Exclusion Criteria:

1. the presence of central nervous system metastases
2. the presence of immunodeficiency disease; previous therapies with immunosuppressants within 14 days prior to the initiation of study treatment;
3. uncontrolled hypertension
4. history of or having pulmonary fibrosis or interstitial lung disease

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MPR(major pathological response); defned as having no more than 10% residual viable tumor cells by routine hematoxylin and eosin (H&E) staining after therapy	Other: Pathological response assessment; The pathological response classification in our study was based on the histopathologic examination of the surgically resected specimens reviewed by two experienced pathologists.
non-MPR; defned as having more than 10% residual viable tumor cells by routine hematoxylin and eosin (H&E) staining after therapy	Other: Pathological response assessment; The pathological response classification in our study was based on the histopathologic examination of the surgically resected specimens reviewed by two experienced pathologists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological response assessment	MPR: Resected tumors with ≤10% viable tumor cells were considered to have a MPR	through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Estimated): November 16, 2024
• Study Completion (Estimated): May 16, 2025

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell
• Other Study ID Numbers: 202311-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No