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
Overview
- Phase
- Phase 2
- Intervention
- Tislelizumab
- Conditions
- NSCLC, Stage III
- Sponsor
- Beijing Tsinghua Chang Gung Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Resectability rate
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
- •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.
Arms & Interventions
Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery
Participants will receive neoadjuvant Tislelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection.
Intervention: Tislelizumab
Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery
Participants will receive neoadjuvant Tislelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection.
Intervention: Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC)
Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery
Participants will receive neoadjuvant Tislelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection.
Intervention: Carboplatin
Outcomes
Primary Outcomes
Resectability rate
Time Frame: At time of surgery
Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.
Secondary Outcomes
- Perioperative G3-4 Adverse Events (AEs)(Up to 1 month post surgery)
- Major pathological response rate (MPR)(At time of surgery)
- Pathology complete response rate(pCR)(At time of surgery)
- R0 Resection rate(At time of surgery)