Bronchoscopic Cryoablation Combined With Chemo-Immunotherapy in NSCLC With Central Airway Obstruc… (NCT06604351) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Bronchoscopic Cryoablation Combined With Chemo-Immunotherapy in NSCLC With Central Airway Obstruction
China39 participantsStarted 2024-09-15
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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 centra…
What they're measuring
1
Objective Response Rate of Airway Tumor
Timeframe: Time from first dose to last dose, or up to 24 month