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OncoMatch/Clinical Trials/NCT04539977

PD-L1 Antibody (TQB2450) Plus Chemotherapy for Previously Untreated Limited- Stage Small-cell Lung Cancer

Is NCT04539977 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including TQB2450 and TQB2450 for small-cell lung cancer.

Phase 2RecruitingShanghai Pulmonary Hospital, Shanghai, ChinaNCT04539977Data as of May 2026

Treatment: TQB2450 · TQB2450This is a non-randomized, open-label, single-center, phase II trial to evaluate the safety and effectiveness of surgery or radiotherapy after PD-L1 inhibitor (TQB2450) and chemotherapy induction therapy followed by maintenance therapy as first-line treatment in patients limited-stage SCLC.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Disease stage

Required: Stage IV, III, LOCAL ADVANCED

extensive stage or limited stage (local advanced) confirmed by imageological examinations.

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

Participants who have received any systemic anti-cancer treatment for SCLC, 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 with liver metastatic tumor

Patients with good function of other main organs (liver, kidney, blood system, etc.): * ANC count ≥1.5×10^9/L, platelet count ≥100×10^9/L,hemoglobin ≥90 g/L; * the international standard ratio of prothrombin time (INR) and prothrombin time (PT) < 1.5 times of upper limit of normal (ULN); * partial thromboplastin time (APTT) ≤1.5×ULN; * total bilirubin ≤1.5×ULN; * alanine aminotransferase (ALT) aspartate aminotransferase (AST) ≤2.5×ULN, or ALT and AST ≤5×ULN in the patients with liver metastatic tumor.

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

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