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OncoMatch/Clinical Trials/NCT04728724

Neoadjuvant Immunotherapy for Stage III Non-small Cell Lung Cancer

Is NCT04728724 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Sintilimab and Chemotherapy for non-small cell lung cancer stage iii.

Phase 2RecruitingShanghai Pulmonary Hospital, Shanghai, ChinaNCT04728724Data as of Jun 2026Location: China

Treatment: Sintilimab · ChemotherapyThis is a phase II, non-randomized, open-label, multi-center study to evaluate the efficacy of neoadjuvant Sintilimab (PD-1 antibody) or combined with chemotherapy as first-line treatment in patients with stage III non-small cell lung cancer (NSCLC).

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Sintilimab

Other

Chemotherapy

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Excluded: EGFR activating mutation

Non-squamous cell carcinoma with EGFR active mutation positive

Excluded: ALK rearrangement

Non-squamous cell carcinoma with ... ALK rearrangement

Disease stage

Required: Stage III

stage III confirmed by imageological examinations (CT, PET-CT or EBUS); Without systematic metastasis (including M1a, M1b and M1c)

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

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

Cannot have received: systemic anti-cancer treatment for thymic epithelial tumor

Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment

Cannot have received: Chinese medicine against cancer

Administration of any Chinese medicine against cancer before administration of the drug

Lab requirements

Blood counts

ANC count ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin ≥90 g/L; INR and PT < 1.5×ULN; APTT ≤1.5×ULN

Kidney function

Liver function

Total bilirubin ≤1.5×ULN; ALT/AST ≤2.5×ULN, or ≤5×ULN in patients with liver metastatic tumor

Patients with good function of other main organs (liver, kidney, blood system, etc.): ... see details

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

Frequently asked questions

Is NCT04728724 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.

Are patients with EGFR alterations eligible?

No. EGFR activating mutation is an exclusion criterion.

Are patients with ALK alterations eligible?

No. ALK rearrangement is an exclusion criterion.

What disease stage is eligible?

Stage III is required.

Is there an age limit?

Yes. Patients must be 75 years or younger.

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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