Trial Title:
Preoperative Neoadjuvant Immunotherapy Combined With Chemotherapy for Stage Ⅲ Unresectable Non-small Cell Lung Cancer
NCT ID:
NCT06357598
Condition:
Non-small-cell Lung Cancer (NSCLC)
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Carboplatin
Pemetrexed
Tislelizumab
Conditions: Keywords:
Non-small-cell Lung Cancer (NSCLC)
Immunotherapy
Chemotherapy
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Tislelizumab: 200mg, ivgtt, day 1 of each 21-day cycle, neoadjuvant therapy : 2-4 cycles;
Adjuvant therapy: 16cycles at most.
Arm group label:
Experimental Group
Other name:
PD-1 antibody
Intervention type:
Drug
Intervention name:
Pemetrexed (Non-squamous NSCLC) or Nab-paclitaxel(Squamous NSCLC)
Description:
Pemetrexed: 500 mg/m^2, ivgtt, day 1 of each 21-day cycle, 2-4 cycles. Nab-paclitaxel:
260mg/m^2, ivgtt, day 1 of each 21-day cycle, 2-4 cycles.
Arm group label:
Experimental Group
Other name:
chemotherapeutic drug
Intervention type:
Drug
Intervention name:
Carboplatin or Cisplatin
Description:
Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of
5 ivgtt on day 1 of each 21-day cycle for 2-4 cycles.
Cisplatin: 75 mg/m^2, ivgtt, day 1 of each 21-day cycle, 2-4 cycles.
Arm group label:
Experimental Group
Other name:
chemotherapeutic drug
Intervention type:
Procedure
Intervention name:
Surgery
Description:
Surgery must be done within the 4th-6th week from day 1 the last cycle of neoadjuvant
treatment.
Arm group label:
Experimental Group
Summary:
Explorative study, which evaluates the effect of Tislelizumab combined with chemotherapy
in neoadjuvant treatment of stage Ⅲ unresectable non-small-cell lung carcinoma.
Detailed description:
This is a open-label, single-arm prospective clinical trial to evaluate the efficacy and
safety of Tislelizumab combined with chemotherapy in neoadjuvant treatment of newly
diagnosed stage Ⅲ unresectable non-small cell lung cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age :18 Years to 75 Years;
2. ECOG physical score status of 0 or 1 points;
3. Expected survival time ≥ 6 months;
4. According to the eighth edition of the AJCC/UICC TNM staging system, patients were
pathological diagnosed with Stage III NSCLC and had one of the following conditions:
1) A complete resection (R0) would not be possible, based on evaluation within a
multidisciplinary team, including an experienced thoracic surgeon; 2) Multiple
ipsilateral mediastinal lymph nodes metastasized into large masses or multistation
metastases (IIIA: T1-2N2 or IIIB: T3-4N2); 3) Contralateral hilar or mediastinal
lymph nodes, or ipsilateral or contralateral scalene or supraclavicular lymph nodes
metastasis (IIIB: T1-2N3; IIIC: T3-4N3); 4) The lesion invaded the heart, aorta, or
esophagus (IIIA: T4N0-1).
5. EGFR mutation or ALK mutation was negative;
6. Patients with at least one evaluable or measurable lesions as per RECIST version
1.1;
7. Patients were newly diagnosed with non-small cell lung cancer, without radiotherapy,
chemotherapy, surgery or molecule-targeted treatment.
8. Patients must have enough cardiopulmonary function for the expected pulmonary
resections for lung cancer.
9. The main organ function meets the following criteria:1) Blood routine:a. ANC ≥
1.5×109/L; b. PLT ≥ 100×109/L; c. HB ≥ 90 g/L; 2) Blood biochemistry:TBIL ≤
1.5×ULN;ALT、AST≤ 2.5×ULN;sCr≤1.5×ULN; 3) Blood coagulation: INR≤1.5×ULN and
APTT≤1.5×ULN，endogenous creatinine clearance rate≥45ml/min(Cockcroft-Gault formula);
10. Pregnancy test (serum or urine) has to be performed for woman of childbearing age
within 7 days before enrolment and the test result must be negative. They shall take
appropriate methods for contraception during the study until the 3 months post the
last administration of study drug. For men, (previous surgical sterilization
accepted), shall agree to take appropriate methods of contraception during the study
until the 3 months post the last administration of study drug;
11. Patient has to voluntarily join the study and sign the Informed Consent Form for the
study.
Exclusion Criteria:
1. Patients with autoimmune disease, or a history of autoimmune disease within 2 years
prior to the first use of the study drug including but not limited to the following:
autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis,
pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism,
hypothyroidism which can be included after hormone replacement therapy; Subjects
with childhood asthma have been completely alleviated and without any intervention
or vitiligo in adulthood can be included;
2. Subjects with congenital or acquired immunodeficiency such as HIV infection, active
hepatitis B (HBV DNA ≥ 2000 IU/mL), hepatitis C (hepatitis C antibody is positive);
3. Subjects with a condition requiring other immunosuppressive medications before 7
days of study drug administration firstly, not including inhaled corticosteroids or
physiological doses of systemic treatment with either corticosteroids (> 10 mg daily
prednisone equivalents);
4. Has received a live vaccine within 4 weeks of planned start of study therapy;
5. Other malignancies have been diagnosed within 5 years prior to the first use of the
study drug (excluding skin basal cell carcinoma that has been cured, skin squamous
cell carcinoma, and / or carcinoma in situ that has undergone radical resection);
6. Patients with a current or history of pulmonary fibrosis, interstitial pneumonia,
pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and severe impairment
of lung function;
7. Patients with serious or uncontrollable systemic diseases, such as:
Patients with hypertension that is difficult to control (systolic blood pressure
≥140 mmHg and diastolic blood pressure ≥90 mmHg); Patients with myocardial ischemia
and myocardial infarction above class II (including QT interval prolongation, for
man ≥ 450 ms, for woman ≥ 470 ms);
8. Severe infection within 4 weeks before the first administration (such as intravenous
drip of antibiotics, antifungal drugs or antiviral drugs), or fever of unknown
origin (> 38.5 ℃) within 4 weeks before the first administration;
9. Allogeneic organ transplantation (except corneal transplantation) or allogeneic
hematopoietic stem cell transplantation;
10. Pregnant or nursing women;
11. Patients with a history of hypersensitivity to any of the study drugs, similar
drugs, or excipients;
12. Participated in other clinical trials within 4 weeks;
13. Patients has received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2
drugs or drugs that target another stimulator or synergistically inhibit T cell
receptors (e.g., CTLA-4, OX-40, CD137);
14. The investigator believes that there are any conditions that may damage the subject
or result in the subject being unable to meet or perform the research request.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
the Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Zip:
266000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhe Wu, PhD
Phone:
+86 17863934867
Email:
17863934867@163.com
Start date:
January 18, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
The Affiliated Hospital of Qingdao University
Agency class:
Other
Source:
The Affiliated Hospital of Qingdao University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06357598
