A Phase 2 interventional study of Multimodal Ablation and Neoadjuvant therapy in NSCLC, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Phase 2, Interventional, and Treatment
This is a prospective, open-label, single-center, single-arm phase II clinical trial evaluating the efficacy and safety of multimodal ablation in combination with perioperative tislelizumab and chemotherapy in patients with pathologically confirmed resectable stage II-IIIB (N2) non-small cell lung cancer (NSCLC).
Eligible patients will receive multimodal ablation, followed by perioperative tislelizumab in combination with platinum-based doublet chemotherapy, and subsequently undergo radical surgical resection. Adjuvant tislelizumab will be continued after surgery.The primary endpoint is the pathological complete response (pCR) rate. Secondary endpoints include major pathological response (MPR) rate, event-free survival (EFS), overall survival (OS), and safety.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 373 studies on the registry; 270 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Sufficient organ function confirmed by laboratory tests within 28 days before enrollment:
Exclusion Criteria:
Patients in this single arm will receive a multimodal ablation procedure, followed by perioperative tislelizumab in combination with platinum-based doublet chemotherapy , and subsequently undergo radical surgical resection. Adjuvant tislelizumab will be continued after surgery as per protocol.
Device: Multimodal Ablation · Drug: Neoadjuvant therapy · Procedure: Surgery · Drug: Adjunctive therapy
CT-guided preoperative multimodal ablation performed with multimodal tumor therapy system.Target lung lesions are ablated within 2 weeks after subject enrollment.
Neoadjuvant tislelizumab (200 mg, IV, Q3W) combined with chemotherapy will be administered within 2 weeks after ablation. For patients with squamous NSCLC, cisplatin or carboplatin combined with paclitaxel will be used; for patients with non-squamous NSCLC, cisplatin or carboplatin combined with pemetrexed will be used, for a total of 3-4 cycles of treatment.
Also known as: Tislelizumab
Surgical resection will be performed within 4-6 weeks after the last neoadjuvant treatment. The pulmonary lesions (including the ablated lesions) will be radically resected via surgery.
Adjuvant therapy will be initiated within 2-8 weeks after surgery. Postoperative adjuvant therapy with tislelizumab (400 mg, Q6W) will be maintained for up to 1 year. Concomitant chemotherapy is allowed during this period based on guidelines/consensus or multidisciplinary team (MDT) discussion.
Also known as: Tislelizumab
Pathological Complete Response Rate
Proportion of patients with no residual viable tumor cells in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant therapy.
Time frame: Perioperative
Major Pathological Response Rate
Proportion of patients with ≤10% residual viable tumor cells in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant therapy. Assessed by pathologist within 2 weeks after surgical resection.
Time frame: Perioperative
Event-Free Survival
Time from start of treatment to the first occurrence of any of the following events: disease progression precluding surgical treatment, local or distant recurrence, or death from any cause. Patients without an event are censored at the date of last imaging assessment.
Time frame: Through study completion, up to 5 years
Overall Survival
Time from enrollment to death due to any cause. Patients alive at last follow-up are censored at the last follow-up date. Lost-to-follow-up patients are censored at the last confirmed survival date.
Time frame: Through study completion, up to 5 years
Incidence and Severity of Adverse Events and Serious Adverse Events
Safety will be assessed by monitoring the incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) graded according to NCI-CTCAE v6.0.
Time frame: Through study completion
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences