Neoadjuvant of Tislelizumab Combined With Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery Participants will receive neoadjuvant Tislelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection. |
Drug: Tislelizumab
Tislelizumab: 200mg, IV, day 1 of each 21-day cycle, Neoadjuvant therapy : 3 cycles
Drug: Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC)
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.
Drug: Carboplatin
AUC 5 mg/mL/min by IV infusion Q3W, given on cycle day 2.
|
Outcome Measures
Primary Outcome Measures
- Resectability rate [At time of surgery]
Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.
Secondary Outcome Measures
- Major pathological response rate (MPR) [At time of surgery]
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.
- Pathology complete response rate(pCR) [At time of surgery]
pCR rate is defined as the percentage of participants lacking of evidence of viable tumor cells in the pathological examination of resected specimens.
- R0 Resection rate [At time of surgery]
R0 Resection rate is defined as the percentage of patients who were able to undergo R0 Resection surgery after neoadjuvant therapy.
- Perioperative G3-4 Adverse Events (AEs) [Up to 1 month post surgery]
The number of participants experiencing an perioperative G3-4 AE will be assessed.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Tsinghua Chang Gung Hospital | Beijing | Beijing | China |
Sponsors and Collaborators
- Beijing Tsinghua Chang Gung Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21416-0-02