- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05942508
A Phase Ib Study of TQB2450 Combined With Anlotinib in Patients With Limited Stage Small Cell Lung Cancer After First-line Radiotherapy and Chemotherapy
July 5, 2023 updated by: Jinming Yu
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
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
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jin ming Yu, postdoctor
- Phone Number: 13806406293
- Email: sdyujinming@126.com
Study Contact Backup
- Name: Xiang jiao Meng, doctor
- Phone Number: 13793150996
- Email: mengxiangjiao@126.com
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250117
- Recruiting
- Cancer Hospital Affiliated to Shandong First Medical University
-
Contact:
- Xiang jiao Meng, doctor
- Phone Number: 13793100996
- Email: mengxiangjiao@sina.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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);
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TQB2450 Injection + Anlotinib Hydrochloride Capsules
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)
|
Anlotinib Hydrochloride Capsules: multi-target receptor tyrosine kinase inhibitor; TQB2450 injection: programmed cell death protein 1 (PD-1) human monoclonal antibody
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse event
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)
|
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
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)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR)
Time Frame: Up to approximately 36 months
|
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.
|
Up to approximately 36 months
|
disease control rate
Time Frame: Up to approximately 36 months
|
The percentage of patients who have achieved remission or stable changes in their condition after treatment compared to the evaluable cases
|
Up to approximately 36 months
|
duration of remission
Time Frame: Up to approximately 36 months
|
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
|
Up to approximately 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2023
Primary Completion (Estimated)
February 1, 2026
Study Completion (Estimated)
February 1, 2026
Study Registration Dates
First Submitted
June 7, 2023
First Submitted That Met QC Criteria
July 5, 2023
First Posted (Actual)
July 12, 2023
Study Record Updates
Last Update Posted (Actual)
July 12, 2023
Last Update Submitted That Met QC Criteria
July 5, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TQB2450-ALTN-Ib-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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