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OncoMatch/Clinical Trials/NCT05913089

A Clinical Study of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Treatment of Non Small Cell Lung Cancer

Is NCT05913089 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including TQB2450 and TQB2450 for non small cell lung cancer.

Phase 2RecruitingChia Tai Tianqing Pharmaceutical Group Co., Ltd.NCT05913089Data as of May 2026

Treatment: TQB2450 · TQB2450This is a clinical study on the efficacy and safety of TQB2450 injection combined with chemotherapy or anlotinib hydrochloride capsule in the perioperative treatment of resectable non-small cell lung cancer. The part I study was planned to enroll 58 subjects, 1:1 randomized into two cohorts. The treatment regimen was as follows: Cohort 1: 3-4 cycles of TQB2450 combined with chemotherapy, surgery should be performed 4-6 weeks after the last administration, and TQB2450 therapy should be continued for 1 year after surgery. Cohort 2: 4 cycles of TQB2450 combined with 3 cycles of anlotinib hydrochloride capsule. Surgery was performed 4-6 weeks after the last dose and continued for 1 year starting 4 weeks after surgery.

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Extracted eligibility criteria

Cancer type

Small Cell Lung Cancer

Biomarker criteria

Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)

Disease stage

Required: Stage II, IIIA, IIIB (T3N2M0 ONLY)

patients with stage II-IIIB (T3N2M0 only) Non-Small Cell Lung Carcinoma (NSCLC) and determined to be eligible for curable R0 excision

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: systemic antitumor therapy

Has not received systemic antitumor therapy, including radiotherapy, chemotherapy and immunotherapy

Cannot have received: hematopoietic stem cell transplant

Exception: within 60 days prior to initial medication

having received a hematopoietic stem cell transplant within 60 days prior to initial medication

Cannot have received: Chinese patent drugs with anti-tumor indications

Exception: within 2 weeks prior to initiation of administration

Received Chinese patent drugs with anti-tumor indications specified in the National Medical Product Administration approved drug package inserts within 2 weeks prior to initiation of administration

Cannot have received: major surgery

Exception: within 4 weeks prior to initiation of medication

Had major surgery within 4 weeks prior to initiation of medication

Lab requirements

Blood counts

Major organs are functioning well.

Kidney function

Major organs are functioning well.

Liver function

Major organs are functioning well.

Cardiac function

Major organs are functioning well.

Major organs are functioning well.

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

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