Tislelizumab Combined With Recombinant Human Endostatin Injection Plus Chemotherapy in Unresectable Stage III NSCLC: a Prospective, Single-arm, Multicenter Phase II Clinical Study

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a prospective, single-arm, multicenter, phase II clinical study designed to evaluate the initial efficacy and safety of patients receiving Tislelizumab in combination with recombinant human endostatin injection plus chemotherapy for stage III unresectable non-small cell lung cancer. To evaluate the surgical conversion rate of tirellizumab combined with recombinant human endostatin injection and chemotherapy induction therapy in patients with initially unresectable stage III non-small cell lung cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Have fully understood the study and voluntarily signed the informed consent;

• Age 18-75 years old, gender is not limited;

• Histologically confirmed Stage III initial unresectable squamous or non-squamous non-small cell lung cancer (AJCC Stage 8th edition)

• \- Unresectable stage III NSCLC mainly refers to imaging or lymph node pathological evidence: Multiple metastases of ipsilateral mediastinal lymph nodes fused into masses or multisite metastases (IIIA: T1-2N2 or IIIB: T3-4N2); metastases to the contralateral hilar, mediastinal lymph nodes, or to the same, contralateral scalene, or supraclavicular lymph nodes (IIIB: T1-2N3, IIIC: T3-4N3); lesion invasion of important organs (including diaphragm, mediastinum, great blood vessels, trachea, recurrent laryngeal nerve, esophagus, or satellite nodules in different pulmonary lobes on the same side of the primary tumor, resulting in clinician determination that R0 resection could not be performed) (IIIA: T4N0-1); Determination of o N2/N3 lymph node involvement: PET-CT was used to confirm lymph node status. In cases where PET-CT is insufficient to determine lymph node staging (for example, lymph node diameter \<2cm), pathologic confirmation (EBUS/EUS/ thoracoscopic/mediastinoscopy or fine needle aspiration biopsy) is performed by the investigator to select appropriate lymph nodes to determine the staging.

• Clinical evaluation of unresectable Stage III NSCLC: Other clinicians determine that R0 resection is not feasible or that a total lung resection is required to achieve R0 resection.

• At least 1 measurable lesion as defined by RECIST v1.1;

• ECOG score 0-1;

• Eligible for platinum-containing double-drug chemotherapy.

• Good organ function;

• • Patients have not received blood transfusion or growth factor support therapy ≤ 14 days prior to sample collection during the screening period and: Absolute neutral cell count (ANC) ≥1.5 x 109/L

⁃ Platelet ≥100 x 109/L

⁃ Hemoglobin ≥90 g/L

‣ • Calculated creatinine clearance (CrCl) (Cockcroft-Gault formula)

⁃ Patients scheduled to receive cisplatin: creatinine clearance ≥ 60 mL/min

⁃ Patients scheduled to receive carboplatin: creatinine clearance ≥ 45 mL/min

• Serum total bilirubin ≤1.5 × upper limit of normal (ULN) (patients with Gilbert\'s syndrome must have total bilirubin \< 3 × ULN)

∙ AST and ALT≤ 2.5 x ULN

∙ Patients who did not receive anticoagulant therapy: International standardized ratio or activated partial thromboplastin time ≤ 1.5 × ULN

∙ Albumin ≥25 g/L (2.5 g/dL).

• Willing and able to comply with study plan visits, treatment plans, laboratory tests and other study procedures;

• The total amount of lung function, as assessed by the surgeon, is sufficient to withstand the proposed pneumonectomy;

⁃ Women of childbearing age must take a serum pregnancy test within 3 days before the first medication, and the result is negative. Female subjects of reproductive age and male subjects whose partners are women of reproductive age must agree to use highly effective methods of contraception during the study period and for 120 days after the last dose of the study drug

Locations
Other Locations
China
Shandong Public Health Clinical Center (ShandongPHCC)
RECRUITING
Jinan
Contact Information
Primary
Hua Zhang, PhD
zhanghua_science@163.com
0531-83347512
Time Frame
Start Date: 2024-08-27
Estimated Completion Date: 2027-09-10
Participants
Target number of participants: 36
Treatments
Experimental: Participant Group/Arm A
Participants receive 2-4 cycles of Tislelizumab With Recombinant human endostatin combined with Chemotherapy treatment during preoperative period, every 3 weeks once for 4 cycles at most.~After neoadjuvant therapy, Patients evaluated for MDT who can be surgically resected will be placed in the surgical group for surgical excision.~Surgery will be performed within 4 to 6 weeks after completion of preoperative therapy.~After surgery, participants will receive adjuvant therapy with tislelizumab combined with recombinant human endostatin injection every 3 weeks until disease progression or postoperative adjuvant therapy for 1 year.
Experimental: Participant Group/Arm B
Participants receive 2-4 cycles of Tislelizumab With Recombinant human endostatin combined with Chemotherapy treatment , every 3 weeks once for 4 cycles at most. After neoadjuvant therapy, Patients evaluated by MDT as unresectable will be placed in the standard treatment group, where the investigator will select the standard treatment regimen determined by the MDT discussion.
Sponsors
Leads: Hua Zhang

This content was sourced from clinicaltrials.gov