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

Primary Purpose

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

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TQB2450 Injection + Anlotinib Hydrochloride Capsules
Sponsored by
Jinming Yu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Limited Stage Small Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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; Exclusion Criteria: 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);

Sites / Locations

  • Cancer Hospital Affiliated to Shandong First Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TQB2450 Injection + Anlotinib Hydrochloride Capsules

Arm Description

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)

Outcomes

Primary Outcome Measures

Adverse event
Incidence and severity of adverse events
serious adverse event
Incidence and Severity of Serious Adverse Events

Secondary Outcome Measures

Overall response rate (ORR)
ORR:According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.the proportion of subjects whose tumors are evaluated as complete response(CR) and partial response(PR) by subcenter imaging evaluation. It is recorded from the first use of the drug to disease progression or initiation of a new anticancer treatment.
disease control rate
The percentage of patients who have achieved remission or stable changes in their condition after treatment compared to the evaluable cases
duration of remission
The time from the first assessment of the tumor as CR or PR to the first assessment as PD (Progressive Disease) or death from any cause

Full Information

First Posted
June 7, 2023
Last Updated
July 5, 2023
Sponsor
Jinming Yu
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1. Study Identification

Unique Protocol Identification Number
NCT05942508
Brief Title
A Phase Ib Study of TQB2450 Combined With Anlotinib in Patients With Limited Stage Small Cell Lung Cancer After First-line Radiotherapy and Chemotherapy
Official Title
An Open, Single Arm, Single Center Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQB2450 Combined With Anlotinib as Maintenance Therapy in Patients With Limited Stage Small Cell Lung Cancer Without Progression After First-line Radiotherapy and Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jinming Yu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Limited Stage Small Cell Lung Cancer, Not Progressed After First-line Chemoradiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TQB2450 Injection + Anlotinib Hydrochloride Capsules
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
TQB2450 Injection + Anlotinib Hydrochloride Capsules
Intervention Description
Anlotinib Hydrochloride Capsules: multi-target receptor tyrosine kinase inhibitor; TQB2450 injection: programmed cell death protein 1 (PD-1) human monoclonal antibody
Primary Outcome Measure Information:
Title
Adverse event
Description
Incidence and severity of adverse events
Time Frame
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)
Title
serious adverse event
Description
Incidence and Severity of Serious Adverse Events
Time Frame
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 Outcome Measure Information:
Title
Overall response rate (ORR)
Description
ORR:According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.the proportion of subjects whose tumors are evaluated as complete response(CR) and partial response(PR) by subcenter imaging evaluation. It is recorded from the first use of the drug to disease progression or initiation of a new anticancer treatment.
Time Frame
Up to approximately 36 months
Title
disease control rate
Description
The percentage of patients who have achieved remission or stable changes in their condition after treatment compared to the evaluable cases
Time Frame
Up to approximately 36 months
Title
duration of remission
Description
The time from the first assessment of the tumor as CR or PR to the first assessment as PD (Progressive Disease) or death from any cause
Time Frame
Up to approximately 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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);
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin ming Yu, postdoctor
Phone
13806406293
Email
sdyujinming@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang jiao Meng, doctor
Phone
13793150996
Email
mengxiangjiao@126.com
Facility Information:
Facility Name
Cancer Hospital Affiliated to Shandong First Medical University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang jiao Meng, doctor
Phone
13793100996
Email
mengxiangjiao@sina.com

12. IPD Sharing Statement

Learn more about this trial

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

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