OncoMatch/Clinical Trials/NCT05892237
CIETAI and Sequential Radiotherapy in Squamous Lung Cancer
Is NCT05892237 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Chemotherapy drug and Immunotherapy for carcinoma, non-small-cell lung.
Treatment: Chemotherapy drug · Immunotherapy — Central-type lung cancer refers to lung malignancies originating from the segmental bronchi and above. The most common tissue type is squamous cell carcinoma. Patients often present with cough, hemoptysis, hoarseness and also some critical conditions including superior vena caval obstruction syndrome. Therefore, effective treatment should be implemented as early as possible to rapidly reduce tumor burden and control the progression of the disease. Most of the central-type NSCLC are classified into T3-4, N1-2 stage and are non-resectable. The PACIFIC study changed the standard treatment model for inoperable locally advanced lung cancer with synchronous chemoradiotherapy and sequential PD-L1 immunotherapy. In clinical practice, Chinese patients often failed to finish concurrent chemoradiotherapy for high toxicity. In addition, combination with PD-1/PD-L1 inhibitors increased the risk of immune related pneumonia. Bronchial artery infusion (BAI), that directly infused drugs (chemo and PD-1 inhibitor) through tumor-nourishing arteries, has potential advantages in the treatment of central-type lung cancer. The drug concentration in tumor region increased to potentiate the antitumoral effect and also reduced the systemic adverse reactions. In this study, bronchial artery interventional therapy is conducted with precedence. The protocol for bronchial artery intervention includes infusion of chemo and PD-1 inhibitor followed by bronchial artery embolism (Chemo-Immulo-embolization via Tumor arterial, CIETAI). Followed CIETAI, two cycles of chemo/PD-1 therapy are planned to carried out before radiotherapy. After radiotherapy, maintenance PD-1 inhibitor are initiated for 1 year or until progression.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)
Disease stage
Required: Stage NANY
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic antineoplastic therapy
Exception: patients who relapsed more than 6 months after adjuvant chemotherapy
Patients received systemic antineoplastic therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C within 6 weeks before the grouping), recieved over-extended-field radiotherapy (EF-RT) within 4 weeks before the grouping or limited-field radiotherapy to evaluate the tumor lesions within 2 weeks before the grouping.
Lab requirements
Blood counts
hemoglobin (HB) ≥ 90 g/L; neutrophil absolute value (ANC) ≥ 1.5×10^9/L; platelet (PLT) ≥80×10^9/L
Kidney function
serum creatinine ≤1.5x ULN or creatinine clearance rate (CCr) ≥ 60 ml/min
Liver function
total bilirubin (TBIL) ≤1.5x ULN; ALT and AST ≤2.5x ULN (≤5x ULN with liver metastasis); serum albumin ≥35g/L
Cardiac function
left ventricular ejection fraction (LVEF) ≥ the low limit of normal value (50%)
Blood routine examination: hemoglobin (HB) ≥ 90 g/L; neutrophil absolute value (ANC) ≥ 1.5×10^9/L; platelet (PLT) ≥80×10^9/L. Biochemical tests: TBIL ≤1.5x ULN; ALT and AST ≤2.5x ULN (≤5x ULN with liver metastasis); serum creatinine ≤1.5x ULN or CCr ≥ 60 ml/min; serum albumin ≥35g/L. Doppler echocardiography: LVEF ≥ the low limit of normal value (50%).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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