A Phase Ib Study of TQB2450 Combined With Anlotinib in Patients With Limited Stage Small Cell Lung Cancer After First-line Radiotherapy and Chemotherapy

NCT05942508 | Recruiting Phase 1

• 1 other identifier: TQB2450-ALTN-Ib-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy and safety of TQB2450 in combination with anlotinib as maintenance therapy in patients with limited-stage small cell lung cancer who do not progress after first-line chemoradiotherapy. Based on the incidence and severity of benign and serious adverse events, as well as abnormal laboratory

Conditions

Limited Stage Small Cell Lung Cancer; Not Progressed After First-line Chemoradiotherapy

Outcome Measures

Primary Outcomes (2)

• Adverse event

  Incidence and severity of adverse events

  Start from the first dose until the last dose to within 84 days after the last dose or start new target indication treatment (whichever occurs first)

• serious adverse event

  Incidence and Severity of Serious Adverse Events

  Start from the first dose until the last dose to within 84 days after the last dose or start new target indication treatment (whichever occurs first)

Secondary Outcomes (3)

• Overall response rate (ORR)

  Up to approximately 36 months

• disease control rate

  Up to approximately 36 months

• duration of remission

  Up to approximately 36 months

Study Arms (1)

TQB2450 Injection + Anlotinib Hydrochloride Capsules

EXPERIMENTAL

TQB2450 injection: 1200 mg/time, intravenous drip, day 1, Q3W; Anlotinib Hydrochloride Capsules: 8 mg/dose, once daily (QD), continuously used for 2 weeks, stopped for 1 week, and taken orally before breakfast (the starting dose of Anlotinib Hydrochloride is 8 mg, and it is allowed to be increased to 10 mg after two cycles of use)

Drug: TQB2450 Injection + Anlotinib Hydrochloride Capsules

Interventions

TQB2450 Injection + Anlotinib Hydrochloride Capsules DRUG

Anlotinib Hydrochloride Capsules: multi-target receptor tyrosine kinase inhibitor; TQB2450 injection: programmed cell death protein 1 (PD-1) human monoclonal antibody

TQB2450 Injection + Anlotinib Hydrochloride Capsules

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject voluntarily joins the study, signs the informed consent form, and has good compliance;
• Age: 18\~75 years old (when signing the informed consent form); ECOG PS score: 0-1 points; Expected survival beyond 6 months; body weight\> 40 kg;
• Patients with pathologically confirmed limited-stage small cell lung cancer (according to the Veterans Administration Lung Study Group (VALG stage);
• Through the neck, chest, abdomen, pelvic enhanced CT and brain plain scan + enhanced MRI examination with diagnostic quality, there is no evidence of metastatic disease (PET-CT examination is recommended before starting radiotherapy and chemotherapy, if not performed before radiotherapy and chemotherapy PET-CT examination, bone scan examination should be performed; PET-CT examination must be performed during the screening period after chemoradiotherapy to exclude metastasis);
• It is expected that no tumor resection will be required during the study (patients who are not suitable for surgery or those who are unwilling to undergo surgery are acceptable);
• Radiotherapy technology adopts three-dimensional conformal radiotherapy, conformal intensity-modulated radiotherapy, tomographic radiation therapy and other precision radiotherapy technologies;
• Patients must achieve CR, PR or SD after receiving radical platinum-based CRT and cannot develop disease progression;
• Patients with at least one measurable lesion confirmed according to RECIST 1.1 criteria prior to chemoradiotherapy;

You may not qualify if:

• Complex small cell lung cancer confirmed by histopathology or cytopathology;
• Subjects with known central nervous system metastasis and/or cancerous meningitis;
• Malignant pleural effusion and pericardial effusion;
• Imaging shows that the tumor has invaded important blood vessels, or the researcher has determined that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies;
• Within 2 weeks before the start of the study treatment, he has received the treatment of traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the NMPA approved drug manual;
• Patients who have received immunomodulatory drugs within 30 days before starting treatment;
• Previously received anti PD-1, anti PD-L1, or anti PD-L2 drugs or medication targeting another stimulating or co inhibitory T cell receptor;
• Previous use of antivascular survival drugs（ bevacizumab, arotinib, apatinib ,ect);

Sponsors & Collaborators

• Jinming Yu: lead

Study Sites (1)

Cancer Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250117, China

RECRUITING

Related Publications (1)

• Liu X, Yin X, Zhuang L, Wen J, Wei Z, Cui W, Yu M, Zhao K, Liu L, Kong L, Jiang L, Jing X, Zhu H, Wang X, Dong X, Yu J, Meng X. Efficacy and safety of TQB2450 combined with anlotinib as maintenance therapy for LS-SCLC after definitive concurrent or sequential chemoradiotherapy: a prospective phase Ib study. BMC Cancer. 2025 Mar 20;25(1):509. doi: 10.1186/s12885-025-13885-8.

  PMID: 40114144 DERIVED

Central Study Contacts

Jin ming Yu, postdoctor

CONTACT

13806406293; sdyujinming@126.com

Xiang jiao Meng, doctor

CONTACT

13793150996; mengxiangjiao@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: July 12, 2023
• Study Start: May 30, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 12, 2023

Record last verified: 2023-07

Locations

CN (1)