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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Other

IBI363 + Chemotherapy

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.

Frequently asked questions

Is NCT07408635 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require EGFR?

Yes, EGFR active mutation is a required biomarker for enrollment.

Does this trial require ALK?

Yes, ALK rearrangement is a required biomarker for enrollment.

What disease stage is eligible?

Stage III is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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