Preoperative Neoadjuvant Immunotherapy Combined With Chemotherapy for Stage Ⅲ Unresectable Non-small Cell Lung Cancer

NCT ID: NCT06357598

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-18
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Non-small-cell Lung Cancer (NSCLC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group

Participants receive 2-4 cycles of Tislelizumab combined with chemotherapy treatment during preoperative period, every 3 weeks for 4 cycles at most.

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

Tislelizumab: 200mg, ivgtt, day 1 of each 21-day cycle, neoadjuvant therapy : 2-4 cycles; Adjuvant therapy: 16cycles at most.

Pemetrexed (Non-squamous NSCLC) or Nab-paclitaxel(Squamous NSCLC)

Intervention Type: DRUG

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.

Carboplatin or Cisplatin

Intervention Type: DRUG

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.

Surgery

Intervention Type: PROCEDURE

Surgery must be done within the 4th-6th week from day 1 the last cycle of neoadjuvant treatment.

Interventions

Tislelizumab

Tislelizumab: 200mg, ivgtt, day 1 of each 21-day cycle, neoadjuvant therapy : 2-4 cycles; Adjuvant therapy: 16cycles at most.

Intervention Type: DRUG

Pemetrexed (Non-squamous NSCLC) or Nab-paclitaxel(Squamous NSCLC)

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.

Intervention Type: DRUG

Carboplatin or Cisplatin

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.

Intervention Type: DRUG

Surgery

Surgery must be done within the 4th-6th week from day 1 the last cycle of neoadjuvant treatment.

Intervention Type: PROCEDURE

Other Intervention Names

PD-1 antibody; chemotherapeutic drug; chemotherapeutic drug

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: lead

Responsible Party

jiaowenjie

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wenjie Jiao, PhD

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Qingdao University

Locations

the Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Zhe Wu, PhD

Role: primary

17863934867@163.com

+86 17863934867

Other Identifiers

QYFYEC2023-95

Identifier Type: -

Identifier Source: org_study_id