Neoadjuvant of Tislelizumab Combined With Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC
NCT ID: NCT05611879
Last Updated: 2023-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2023-03-12
2024-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery
Participants will receive neoadjuvant Tislelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection.
Tislelizumab
Tislelizumab: 200mg, IV, day 1 of each 21-day cycle, Neoadjuvant therapy : 3 cycles
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.
Carboplatin
AUC 5 mg/mL/min by IV infusion Q3W, given on cycle day 2.
Interventions
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Tislelizumab
Tislelizumab: 200mg, IV, day 1 of each 21-day cycle, Neoadjuvant therapy : 3 cycles
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.
Carboplatin
AUC 5 mg/mL/min by IV infusion Q3W, given on cycle day 2.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Beijing Tsinghua Chang Gung Hospital
OTHER
Responsible Party
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Principal Investigators
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Donghong Chen, Dr.
Role: PRINCIPAL_INVESTIGATOR
Beijing Tsinghua Chang Gung Hospital
Locations
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Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Fan Yang, Dr.
Role: primary
Other Identifiers
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21416-0-02
Identifier Type: -
Identifier Source: org_study_id