OncoMatch/Clinical Trials/NCT07016126

D-BACE in Combination With Chemotherapy and Carelizumab for Resectable II-IIIA or Potentially Resectable T3-4N2 Stage IIIB NSCLC

Is NCT07016126 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies D-BACE in combination with chemotherapy and karelizumab for nsclc (non-small cell lung cancer).

Phase 3RecruitingGuangdong Provincial People's HospitalNCT07016126Data as of May 2026

Treatment: D-BACE in combination with chemotherapy and karelizumab — This study is a single-arm prospective single-center phase II study. Subjects are untreated resectable II-IIIIA or potentially resectable T3-4N2 stage IIIB NSCLC. 70 subjects will be enrolled in this prospective observation aimed at evaluating the clinical efficacy and safety of D-BACE in combination with neoadjuvant chemotherapy and carelizumab in patients with resectable II-IIIIA or potentially resectable T3-4N2 stage IIIB NSCLC. The treatment group regimen will be 3 cycles of D-BACE (DCB-loaded microspheres loaded with epirubicin 50 mg) in combination with chemotherapy and carelizumab (the specific regimen of chemotherapy will be determined by the investigator, and platinum-containing two-agent chemotherapy will generally be used). Adverse events will be monitored throughout the trial and graded for severity according to NCI CTCAE version 5.0. Tissue and blood specimens will be dynamically collected during the course of treatment for translational research.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: PD-L1 (CD274) IHC testing required (testing required; no eligibility threshold specified)

PD-L1 IHC testing was performed at a central laboratory during the screening phase

Required: EGFR targeted alteration

Patients were excluded if their tumors had targeted alterations in EGFR

Required: ALK targeted alteration

Patients were excluded if their tumors had targeted alterations in ... ALK

Required: ROS1 targeted alteration

or were known to have targeted alterations in ROS1

Required: BRAF targeted alteration

or were known to have targeted alterations in ... BRAF

Required: HER2 (ERBB2) targeted alteration

or were known to have targeted alterations in ... HER-2

Required: NTRK1 targeted alteration

or were known to have targeted alterations in ... NTRK

Required: NTRK2 targeted alteration

or were known to have targeted alterations in ... NTRK

Required: NTRK3 targeted alteration

or were known to have targeted alterations in ... NTRK

Required: MET targeted alteration

or were known to have targeted alterations in ... MET

Required: RET targeted alteration

or were known to have targeted alterations in ... RET

Disease stage

Required: Stage II, IIIA, T3-4N2 STAGE IIIB

Excluded: Stage I, IIIB/IIIC (N3), IV

Resectable II-IIIA or Potentially Resectable T3-4N2 Stage IIIB NSCLC

Performance status

ECOG 0–1(Restricted strenuous activity)

Eastern Cooperative Oncology Group performance status ≤1

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: immune checkpoint inhibitor

patients with previous ICIs immunotherapy ... were excluded

Cannot have received: targeted therapy

patients with previous ... targeted therapy ... were excluded

Cannot have received: chemotherapy

patients with previous ... chemotherapy ... were excluded

Cannot have received: systemic antitumor therapy

patients with previous ... other systemic antitumor therapies were excluded

Lab requirements

Blood counts

White blood cell count ≥ 2000/uL, neutrophil ≥ 1500/uL, platelet ≥ 100×10^3/uL, hemoglobin ≥ 9.0g/dL

Kidney function

Serum creatinine ≤ 1.5x ULN or calculated creatinine clearance (CrCl) ≥ 50 ml/min

Liver function

Serum total bilirubin ≤ 1.5x ULN; AST and ALT ≤ 5x ULN with liver metastases

Laboratory screening values must exclude the following criteria (CTCAE version 5 applies): White blood cell count < 2000/uL, neutrophil < 1500/uL, platelet < 100×10^3/Ul, hemoglobin < 9.0g/dL; Serum total bilirubin > 1.5x ULN; AST and ALT > 5x ULN with liver metastases; Serum creatinine > 1.5x ULN or calculated creatinine clearance (CrCl) < 50ml/min

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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