Bronchoscopic Cryoablation Combined With Chemo-Immunotherapy in NSCLC With Central Airway Obstruction

NCT06604351 | Not Yet Recruiting Phase 2

• 1 other identifier: 20240827
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the efficacy and safety of bronchoscopic cryoablation combined with sintilimab plus platinum-based chemotherapy as First-line Treatment for locally advanced or metastatic NSCLC with central airway obstruction.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate of Airway Tumor

  The ORR for Objective response of airway tumors after cryoablation combined with immunochemotherapy was evaluated according to the investigator's Solid Tumor Response Assessment Criteria (RECIST) version 1.1, defined as the proportion of subjects who were evaluated for complete response (CR) + partial response (PR) to airway tumors after the first documented treatment

  Time from first dose to last dose, or up to 24 month

Secondary Outcomes (8)

• Pathological Response Rate of Airway Obstruction

  Time from first dose to last dose, or up to 24 month

• Airway Obstruction Response Control Rate

  Time from first subject dose to study completion, or up to 36 month

• FEV1R improvement rate of airway obstruction

  Time from first subject dose to study completion, or up to 36 month

• Airway Obstruction Response Duration

  Time from first subject dose to study completion, or up to 36 month

• Progression-free survival

  Time from first subject dose to study completion, or up to 36 month

Study Arms (1)

group 1

EXPERIMENTAL

Bronchial endoscopic cryoablation

Drug: Sintilimab, Nab-Paclitaxel, and Carboplatin

Interventions

Sintilimab, Nab-Paclitaxel, and Carboplatin DRUG

Cryoablation received at least 2 or more depending on the mass, with 2-3 cycles；Sintilimab 200 mg Q3W plus Nab-Paclitaxel 260mg / m2(Day 1) Q3W + carboplatin AUC 4.25 or 5 (Day 1) Q3W, 4 cycles，until 24 months

group 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand the requirements and contents of the clinical trial and provide a signed and dated informed consent form.
• Age≥18 years and≤80 years.
• Histologically or cytologically confirmed and documented locally advanced or metastatic non-small cell lung cancer (NSCLC) without prior systemic therapy and EGFR-sensitive mutations (19del, L858R and T790M).
• Presence of a palliative treatment lesion in the central airway that is amenable to ablation, endoscopically assessed to be≥1/3 obstruction, such as primary or metastatic malignancy to the trachea, main bronchi, intermediate bronchi, or segmental bronchi. corresponding respiratory symptoms or obstructive pneumonia is permission to be included.
• Eastern Cooperative Oncology Group (ECOG) ： 0-2.
• Predicted survival ≥ 12 weeks.
• Adequate bone marrow hematopoiesis and organ function (cardiac function, hepatic, and renal function).
• Presence of measurable lesions according to RECIST 1.1 criteria.
• Subjects with stable brain metastases may be included in the study.

You may not qualify if:

• Histological diagnosis of small cell, large cell lung cancer; mixed tumors will be classified based on the primary cell type; if the primary component is small cell, large cell, or neuroendocrine carcinoma, the subject will not be eligible for enrollment; however, mixed adenocarcinoma-squamous cell carcinoma is acceptable. Subjects with driver gene mutations are generally not eligible for enrollment.
• Malignant central airway obstruction with acute dyspnea or severe life-threatening symptoms of malignant airway stenosis, or assessed by the investigator to be unable to tolerate subsequent treatment; extrinsic airway compression; large pleural effusion, severe coughing, massive hemoptysis, dyspnea, or inability to cooperate; severely impaired lung function with a maximal voluntary ventilation (MVV) \< 39% or inability to ambulate.
• Prior systemic therapy for locally or metastatic disease.
• Uncorrectable coagulation disorders, severe bleeding tendencies, platelet count \< 50 \*10\^9/L, or severe coagulation dysfunction.
• Presence of symptomatic brain metastases.
• Known severe hypersensitivity to anti-PD-1 monoclonal antibodies or similar drugs (allergic reactions with CTCAE≥ grade 3 toxicity).
• Subjects with persistent or active infection, including but not limited to hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV).
• Any concurrent malignancy other than basal cell carcinoma or cervical carcinoma in situ. (Patients with a history of malignant tumors but with no evidence of disease for≥ 3 years may be included ).
• Women who are breastfeeding or pregnant.
• Other conditions assessed by the investigator to be unsuitable for participation in the study.

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Hunan Cancer hospital

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sintilimab; 130-nm albumin-bound paclitaxel; Carboplatin

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)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Yongchang Zhang

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Medical Oncology, Director of Early Clinical Trial Center

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): May 31, 2029
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)