Tislelizumab Combined With Chemotherapy as Neoadjuvant Therapy for Stage IIIA-IIIB (N2) Lung Squamous Cell Carcinoma

NCT05024266 | Unknown Phase 2

• 1 other identifier: IIT20210011C-R1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Tislelizumab combined with chemotherapy has shown good efficacy and safety in clinical studies of lung adenocarcinoma (RATIONALE 304) and lung squamous cell carcinoma (RATIONALE 307), thus has been approved as the first-line therapy for advanced non-small cell lung cancer (NSCLC) in China. However, there is no data in the field of neoadjuvant therapy for NSCLC. This single-arm, single-center phase II clinical study is designed to evaluate the efficacy, safety and major pathological response (MPR) of Tislelizumab combined with chemotherapy as neoadjuvant therapy in patients with stage IIIA-IIIB (N2) lung squamous cell carcinoma. Biomarkers correlated with efficacy outcomes will also be explored.

Conditions

Lung Squamous Cell Carcinoma; Neoadjuvant Therapy; Immunotherapy

Keywords

Lung Squamous Cell Carcinoma; neoadjuvant therapy; immunotherapy

Outcome Measures

Primary Outcomes (2)

• Major Pathological Response (MPR)

  Major Pathological Response (MPR) is evaluated after resection by pathologists, which is defined as a metric of ≤10% residual tumor tissue after neoadjuvant therapy.

  2-4 weeks after resection

• Incidence of Treatment-Emergent Adverse Events

  Adverse events are evaluated by investigators according to CTCAE 5.0.

  Through the trial

Secondary Outcomes (4)

• Rate of radical resection (R0)

  4 weeks after resection

• Overall Response Rate (ORR)

  4 weeks after resection

• Disease-free survival (DFS)

  1 year and 2 years after resection

• Overall survival (OS)

  Through the trial

Study Arms (1)

Tislelizumab + Albumin Paclitaxel + Carboplatin

EXPERIMENTAL

Tislelizumab 200mg d1, Albumin Paclitaxel 260mg/m2 d1, Carboplatin AUC5 d1, Q3W

Drug: Tislelizumab

Interventions

Tislelizumab DRUG

Participants received 2 cycles Tislelizumab 200mg d1 + Albumin Paclitaxel 260mg/m2 d1 + Carboplatin AUC5 d1 every 3 weeks, and then were evaluated for surgery.

Also known as: Albumin Paclitaxel, Carboplatin

Tislelizumab + Albumin Paclitaxel + Carboplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The age is ≥18 years old and \<75 years old.
• Eastern Cooperative Oncology Group (ECOG) physical status is 0 or 1.
• Untreated and histologically confirmed squamous cell lung carcinoma.
• Potentially operable stage IIIA-IIIB (N2) squamous cell lung carcinoma on enrollment (as defined by the American Joint Committee on Cancer 8th Edition).
• Sufficient pre-treatment tumor tissue samples/peripheral blood samples for biomarker analysis.
• Sufficient organ functions, including: Haematological status: absolute neutrophil count(ANC) ≥1.5×10\^9 /L, platelet count(PLT) ≥100×10\^9 /L, hemoglobin(HB) ≥90 g/L; Liver function: alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN), total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN); Kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN) or Creatinine clearance ≥45 ml/min (calculated according to Cockcroft-Gault equation)

You may not qualify if:

• Participants with known EGFR, ALK or ROS1 sensitive mutations.
• Participants with autoimmune diseases, tuberculosis, active hepatitis or HIV.
• Participants who are not expected to tolerate surgery, such as patients with cardiopulmonary insufficiency, etc.
• A history of other malignant tumors in the past 5 years, except for cured cervical carcinoma in situ, cured basal cell carcinoma of the skin and superficial bladder cancer \[Ta, Tis \& T1\].
• Participants who have used PD-1/PD-L1 and other immunotherapy drugs before.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (1)

• Shan J, Liu Z, Chen S, Du C, Li B, Ruan L, Kong M, Wang L, Du M, Shi S, Qiao G, Tian T, Tu Z. Optimizing perioperative treatment for potentially resectable stage III squamous cell lung carcinoma: promising results of a condensed four-cycle regimen with tislelizumaband chemotherapy. BMC Med. 2024 Jun 10;22(1):234. doi: 10.1186/s12916-024-03462-4.

  PMID: 38853265 DERIVED

MeSH Terms

Interventions

tislelizumab; Carboplatin

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Yujie Huang

CONTACT

0571-87236560; zyct79@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 27, 2021
• Study Start: August 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2023
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)