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

NCT06357598 | Recruiting Phase 4 DMC

• 1 other identifier: QYFYEC2023-95
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small-cell Lung Cancer (NSCLC)

Keywords

Non-small-cell Lung Cancer (NSCLC); Immunotherapy; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• R0 Resection Rate

  R0 Resection Rate: The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope.

  1 month after surgery

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  Pre-operation

• Resectability Rate

  Pre-operation

• Major Pathological Response (MPR) Rate

  1 month after surgery

• Rate of grade 3 and higher grade treatment-related adverse events

  From date of treatment allocation until surgery or within 30 days after last dose of preoperative treatment

• Progression-Free Survival (PFS)

  Up to 12 months

Other Outcomes (1)

• Pathological Complete Response (pCR) Rate

  1 month after surgery

Study Arms (1)

Experimental Group

EXPERIMENTAL

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

Drug: Tislelizumab; Drug: Pemetrexed (Non-squamous NSCLC) or Nab-paclitaxel(Squamous NSCLC); Drug: Carboplatin or Cisplatin; Procedure: Surgery

Interventions

Tislelizumab DRUG

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

Also known as: PD-1 antibody

Experimental Group

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

Also known as: chemotherapeutic drug

Experimental Group

Carboplatin or Cisplatin 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.

Also known as: chemotherapeutic drug

Experimental Group

Surgery PROCEDURE

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

Experimental Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age :18 Years to 75 Years;
• ECOG physical score status of 0 or 1 points;
• Expected survival time ≥ 6 months;
• 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).
• EGFR mutation or ALK mutation was negative;
• Patients with at least one evaluable or measurable lesions as per RECIST version 1.1;
• Patients were newly diagnosed with non-small cell lung cancer, without radiotherapy, chemotherapy, surgery or molecule-targeted treatment.
• Patients must have enough cardiopulmonary function for the expected pulmonary resections for lung cancer.
• 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);
• 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;
• Patient has to voluntarily join the study and sign the Informed Consent Form for the study.

You may not qualify if:

• 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;
• 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);
• 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);
• Has received a live vaccine within 4 weeks of planned start of study therapy;
• 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);
• Patients with a current or history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and severe impairment of lung function;
• 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);
• 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;
• Allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
• Pregnant or nursing women;
• Patients with a history of hypersensitivity to any of the study drugs, similar drugs, or excipients;
• Participated in other clinical trials within 4 weeks;
• 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);
• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

the Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

tislelizumab; spartalizumab; Pemetrexed; Antineoplastic Agents; Carboplatin; Cisplatin; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Wenjie Jiao, PhD

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 10, 2024
• Study Start: January 18, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)