## Protocol Section
### Identification Module
**NCT ID:** NCT05611879

**Brief Title:** Neoadjuvant of Tislelizumab Combined With Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC

**Official Title:** Efficacy and Safety of Tislelizumab With Platinum Doublet Chemotherapy as Neoadjuvant Therapy for Participants With Initially Unresectable Stage III Non-small Cell Lung Cancer: A Single-arm, Phase II Trial

#### Organization Study ID Info
**ID:** 21416-0-02
#### Organization
**Class:** OTHER
**Full Name:** Beijing Tsinghua Chang Gung Hospital
### Status Module
#### Completion Date
**Date:** 2024-04-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-12-29

**Type:** ACTUAL

**Last Update Submit Date:** 2023-12-28

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-02-29

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-03-12

**Type:** ACTUAL

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2022-11-10
**Type:** ACTUAL
**Study First Submit Date:** 2022-11-04
**Study First Submit QC Date:** 2022-11-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Beijing Tsinghua Chang Gung Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this conversion therapy study is to evaluate the safety and efficacy of neoadjuvant of Tislelizumab combined with platinum doublet for stage III unresectable locally advanced NSCLC.

### Conditions Module

**Conditions:**

- NSCLC, Stage III

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive neoadjuvant Tislelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection.

**Intervention Names:**

- Drug: Tislelizumab

- Drug: Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC)

- Drug: Carboplatin

**Label:** Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery

**Description:** Tislelizumab: 200mg, IV, day 1 of each 21-day cycle, Neoadjuvant therapy : 3 cycles

**Name:** Tislelizumab

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery

**Description:** Pemetrexed: 500 mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles. Paclitaxel: 60-75mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles. Nab-paclitaxel: 260mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles.

**Name:** Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC)

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery

**Description:** AUC 5 mg/mL/min by IV infusion Q3W, given on cycle day 2.

**Name:** Carboplatin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.

**Measure:** Resectability rate

**Time Frame:** At time of surgery

#### Secondary Outcomes

**Description:** MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.

**Measure:** Major pathological response rate (MPR)

**Time Frame:** At time of surgery

**Description:** pCR rate is defined as the percentage of participants lacking of evidence of viable tumor cells in the pathological examination of resected specimens.

**Measure:** Pathology complete response rate(pCR)

**Time Frame:** At time of surgery

**Description:** R0 Resection rate is defined as the percentage of patients who were able to undergo R0 Resection surgery after neoadjuvant therapy.

**Measure:** R0 Resection rate

**Time Frame:** At time of surgery

**Description:** The number of participants experiencing an perioperative G3-4 AE will be assessed.

**Measure:** Perioperative G3-4 Adverse Events (AEs)

**Time Frame:** Up to 1 month post surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Written informed consent provided.
* Unresectable stage III non-small cell lung cancer confirmed by histopathology or cytology.
* ECOG score is 0 or 1.
* Adequate hematological function, liver function and renal function.

Exclusion Criteria:

* Previously received systemic anti-tumor therapy for non-small cell lung cancer.
* history or current (non-infectious) pneumonia/interstitial pneumonia requiring steroid treatment.
* History or active pulmonary tuberculosis.
* Active infections that require systemic treatment.
* History or suspected autoimmune disease or immune deficiency who, in the judgment of the investigator, cannot tolerate immunotherapy.
* Untreated active Hepatitis B.
* Has a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive).
* Grade 3 or above peripheral neuropathy.
* Severe allergic history to pemetrexed, paclitaxel, albumin-bound paclitaxel, carboplatin or other preventive drugs.
* Underlying severe or uncontrolled disease.
* Malignant tumors other than NSCLC within 5 years.
* Any medical condition requiring systemic treatment with corticosteroids (prednisone or equivalent at a dose of \>10mg/ day) or other immunosuppressive agents within 14 days prior to treatment.

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Yfa01087@btch.edu.cn

**Name:** Fan Yang, Dr.

**Phone:** +86-10-56112345

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** Yfa01087@btch.edu.cn

- **Name:** Fan Yang, Dr.

- **Phone:** +86-10-56112345

- **Role:** CONTACT

**Country:** China

**Facility:** Beijing Tsinghua Chang Gung Hospital

**State:** Beijing

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Beijing Tsinghua Chang Gung Hospital

**Name:** Donghong Chen, Dr.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M11172

- Name: Lung Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5546

- Name: Carcinoma, Non-Small-Cell Lung

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000000972

- Term: Antineoplastic Agents, Phytogenic

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000050257

- Term: Tubulin Modulators

- ID: D000050256

- Term: Antimitotic Agents

- ID: D000050258

- Term: Mitosis Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000005493

- Term: Folic Acid Antagonists

- ID: D000019384

- Term: Nucleic Acid Synthesis Inhibitors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M137899

- Name: Tislelizumab

- Relevance: HIGH

- As Found: Healthcare

- ID: M19537

- Name: Paclitaxel

- Relevance: HIGH

- As Found: Surgery

- ID: M231

- Name: Albumin-Bound Paclitaxel

- Relevance: LOW

- As Found: Unknown

- ID: M18650

- Name: Carboplatin

- Relevance: HIGH

- As Found: System

- ID: M264

- Name: Pemetrexed

- Relevance: HIGH

- As Found: General

- ID: M26197

- Name: Tubulin Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M26196

- Name: Antimitotic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M8618

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M17546

- Name: Vitamin B Complex

- Relevance: LOW

- As Found: Unknown

- ID: M8619

- Name: Folic Acid Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: T447

- Name: Folinic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T446

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T448

- Name: Folate

- Relevance: LOW

- As Found: Unknown

- ID: T475

- Name: Vitamin B9

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017239

- Term: Paclitaxel

- ID: D000016190

- Term: Carboplatin

- ID: D000068437

- Term: Pemetrexed

- ID: C000707970

- Term: Tislelizumab

### Misc Info Module

- Version Holder: 2024-05-24
