Clinical trial · Interventional
Neoadjuvant of Tislelizumab Combined With Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC
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
NCT05611879CI-TRIAL-00072618unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC, Stage III | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC) | Drug | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery
- description
- Participants will receive neoadjuvant Tislelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection.
- interventionNames
- Drug: Tislelizumab
- Drug: Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC)
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Resectability rate
- timeFrame
- At time of surgery
- description
- Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.
Secondary outcomes (4)
- measure
- Major pathological response rate (MPR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.