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

Lung Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06436040
• Other study ID #: 202311-10
• Status: Recruiting
• Start date: January 24, 2024
• Est. completion date: May 16, 2025

Study information

• Verified date: May 2024
• Source: Tang-Du Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 16, 2025
• Est. primary completion date: November 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Lung Squamous Cell Carcinoma

Intervention

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.

Locations

Country	Name	City	State
China	Hongtao Duan	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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