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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Other

TQB2450TQB2450

Cancer type

Small Cell Lung Cancer

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)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT04539977 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.

What disease stage is eligible?

Stage IV or III or LOCAL ADVANCED 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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