Clinical trial · Interventional
Tislelizumab Combined With Chemotherapy as Neoadjuvant Therapy for Stage IIIA-IIIB (N2) Lung Squamous Cell Carcinoma
Tislelizumab Combined With Albumin Paclitaxel + Carboplatin as Neoadjuvant Therapy for Patients With Stage IIIA-IIIB (N2) Lung Squamous Cell Carcinoma: A Single-arm, Single-center, Exploratory Phase II Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immunotherapy | — | UNRESOLVED | — |
| Lung Squamous Cell Carcinoma | Lung Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tislelizumab + Albumin Paclitaxel + Carboplatin
- description
- Tislelizumab 200mg d1, Albumin Paclitaxel 260mg/m2 d1, Carboplatin AUC5 d1, Q3W
- interventionNames
- Drug: Tislelizumab
Primary outcomes (2)
- measure
- Major Pathological Response (MPR)
- timeFrame
- 2-4 weeks after resection
- description
- Major Pathological Response (MPR) is evaluated after resection by pathologists, which is defined as a metric of ≤10% residual tumor tissue after neoadjuvant therapy.
- measure
- Incidence of Treatment-Emergent Adverse Events
- timeFrame
- Through the trial
- description
- Adverse events are evaluated by investigators according to CTCAE 5.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. The age is ≥18 years old and \<75 years old. 2. Eastern Cooperative Oncology Group (ECOG) physical status is 0 or 1. 3. Untreated and histologically confirmed squamous cell lung carcinoma. 4. Potentially operable stage IIIA-IIIB (N2) squamous cell lung carcinoma on enrollment (as defined by the American Joint Committee on Cancer 8th Edition). 5. Sufficient pre-treatment tumor tissue samples/peripheral blood samples for biomarker analysis. 6. 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) Exclusion Criteria: 1. Participants with known EGFR, ALK or ROS1 sensitive mutations. 2. Participants with autoimmune diseases, tuberculosis, active hepatitis or HIV. 3. Participants who are not expected to tolerate surgery, such as patients with cardiopulmonary insufficiency, etc. 4. 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 \[Ta, Tis \& T1\]. 5. Participants who have used PD-1/PD-L1 and other immunotherapy drugs before. 6. Women of childbearing age as the exclusion criteria.
References
Publications (1)
- DERIVEDShan 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