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OncoMatch/Clinical Trials/NCT07408635

IBI363 (PD-1/IL-2α-bias) in Combination With Chemotherapy as Neoadjuvant Therapy in Initially Unresectable Stage III Non-Small Cell Lung Cancer

Is NCT07408635 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies IBI363 + Chemotherapy for unresectable stage iii non-small cell lung cancer.

Phase 2RecruitingShanghai Pulmonary Hospital, Shanghai, ChinaNCT07408635Data as of May 2026

Treatment: IBI363 + ChemotherapyThis study is a single-arm, phase II clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a neoadjuvant treatment of non-small cell lung cancer.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR active mutation

Non-squamous and squamous NSCLC with EGFR active mutation positive ... are excluded

Required: ALK rearrangement

Non-squamous and squamous NSCLC with ... ALK rearrangement ... are excluded

Disease stage

Required: Stage III

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic anti-cancer treatment

Lab requirements

Blood counts

anc count ≥ 1.5 × 10⁹/l; platelet count ≥ 100 × 10⁹/l; hemoglobin ≥ 90 g/l

Kidney function

serum cr ≤ 1.5 times of upper limit of normal (uln) or calculated creatinine clearance (clcr) ≥ 50 ml/min

Liver function

total bilirubin ≤ 1.5 × uln (≤ 3 × uln in gilbert's syndrome); ast and alt ≤ 2.5 × uln

Cardiac function

left ventricular ejection fraction (lvef) ≥ 50 %

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

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