## Protocol Section
### Identification Module
**NCT ID:** NCT06436040

**Brief Title:** Mechanism Study to Investigate Difference in Efficacy of Neoadjuvant Chemoimmunotherapy in Lung Squamous Cell Carcinoma

**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

#### Organization Study ID Info
**ID:** 202311-10
#### Organization
**Class:** OTHER
**Full Name:** Tang-Du Hospital
### Status Module
#### Completion Date
**Date:** 2025-05-16

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-11-16

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-24

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-22
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Tang-Du Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

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

**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.

### Conditions Module

**Conditions:**

- Tumor Microenvironment

- Lung Squamous Cell Carcinoma

- Neoadjuvant Chemoimmunotherapy

### Design Module

#### Bio Spec

**Description:** pre-treatment and post-treatment tumors from patients with operable locally advanced lung squamous cell carcinoma

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** defned as having no more than 10% residual viable tumor cells by routine hematoxylin and eosin (H\&E) staining after therapy

**Intervention Names:**

- Other: Pathological response assessment

**Label:** MPR(major pathological response)

#### Arm Group 2

**Description:** defned as having more than 10% residual viable tumor cells by routine hematoxylin and eosin (H\&E) staining after therapy

**Intervention Names:**

- Other: Pathological response assessment

**Label:** non-MPR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- MPR(major pathological response)

- non-MPR

**Description:** The pathological response classification in our study was based on the histopathologic examination of the surgically resected specimens reviewed by two experienced pathologists.

**Name:** Pathological response assessment

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** MPR: Resected tumors with ≤10% viable tumor cells were considered to have a MPR

**Measure:** Pathological response assessment

**Time Frame:** through study completion, an average of 2 year

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 80 Years

**Minimum Age:** 40 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Xi'an

**Contacts:**

***Contact 1:***

- **Email:** 646014852@qq.com

- **Name:** Hongtao Duan, Dr.

- **Phone:** 02984717569

- **Role:** CONTACT

**Country:** China

**Facility:** Hongtao Duan

**State:** Shanxi

**Status:** RECRUITING

**Zip:** 710038

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000018307

- Term: Neoplasms, Squamous Cell

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M5550

- Name: Carcinoma, Squamous Cell

- Relevance: HIGH

- As Found: Squamous Cell Carcinoma

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M20451

- Name: Neoplasms, Squamous Cell

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000002294

- Term: Carcinoma, Squamous Cell

### Misc Info Module

- Version Holder: 2024-05-31
