Clinical trial NCT06604351: Bronchoscopic Cryoablation Combined With Chemo-Immunotherapy in NSCLC With Central Airway Obstruction
Official title: 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: A Phase II Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This is a prospective interventional clinical study 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 Non-small Cell Lung Cancer with central airway obstruction.

Approximately 39 patients with locally advanced or metastatic NSCLC and central airway obstruction, without EGFR-sensitive mutations (19del, L858R, and T790M), were enrolled and treated with bronchoscopic cryoablation combined with Sintilimab, Nab-Paclitaxel, and Carboplatin until disease progression, intolerable toxicity, or meeting the criteria for discontinuation of the trial drug.

The primary endpoint is the investigator-assessed objective response rate (ORR) of airway tumors. Secondary endpoints include the pathological response rate (PRR) of airway tumors, disease control rate (DCR), improvement rate of FEV1, duration of response (DOR) for airway tumors, progression-free survival (PFS), overall survival (OS), quality of life assessment, and safety. Recruitment for the study is expected to begin in mainland China around October 2024, with the trial anticipated to conclude in October 2027.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Objective Response Rate of Airway Tumor
timeFrame: Time from first dose to last dose, or up to 24 month
Secondary outcomes:
measure: Pathological Response Rate of Airway Obstruction
timeFrame: Time from first dose to last dose, or up to 24 month
measure: Airway Obstruction Response Control Rate
timeFrame: Time from first subject dose to study completion, or up to 36 month
measure: FEV1R improvement rate of airway obstruction
timeFrame: Time from first subject dose to study completion, or up to 36 month
measure: Airway Obstruction Response Duration
timeFrame: Time from first subject dose to study completion, or up to 36 month
measure: Progression-free survival
timeFrame: Time from first subject dose to study completion, or up to 36 month
measure: Overall survival
timeFrame: Time from first subject dose to study completion, or up to 36 month
measure: Adverse events
timeFrame: Time from first subject dose to study completion, or up to 36 month
measure: Life quality score
timeFrame: Time from first subject dose to study completion, or up to 36 month
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer hospital
state: Hunan
Study officials:
References: