Limited Stage Small Cell Lung CancerPhase 1NCT05942508
A Phase Ib Study of TQB2450 Combined With Anlotinib in Patients With Limited Stage Small Cell Lung Cancer After First-line Radiotherapy and Chemotherapy
A Phase 1 study testing TQB2450 Injection + Anlotinib Hydrochloride Capsules in people with Limited Stage Small Cell Lung Cancer and Not Progressed After First-line Chemoradiotherapy, run by Jinming Yu at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Limited Stage Small Cell Lung Cancer, Not Progressed After First-line Chemoradiotherapy
- What is being tested?
- TQB2450 Injection + Anlotinib Hydrochloride Capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2023to Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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);
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250117
Xiang jiao Meng, doctor, 13793100996, mengxiangjiao@sina.com
About this study
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
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
- Being tested
- TQB2450 Injection + Anlotinib Hydrochloride Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2450 Injection + Anlotinib Hydrochloride CapsulesDrug
Anlotinib Hydrochloride Capsules: multi-target receptor tyrosine kinase inhibitor; TQB2450 injection: programmed cell death protein 1 (PD-1) human monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: TQB2450 Injection + Anlotinib Hydrochloride Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
Incidence and severity of adverse events
Measured: 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
Measured: 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)
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.
Measured: Up to approximately 36 months
disease control rate
The percentage of patients who have achieved remission or stable changes in their condition after treatment compared to the evaluable cases
Measured: Up to approximately 36 months
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
Measured: Up to approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start30 May 2023
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Limited Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinming Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jinming Yu, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942508
- Sponsor's protocol ID
- TQB2450-ALTN-Ib-02
- Status last verified
- Jul 2023
- First submitted
- 7 Jun 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40114144
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05942508
- Acronym / sponsor ID
- TQB2450-ALTN-Ib-02
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jinming YuUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB2450 Injection + Anlotinib Hydrochloride Capsules | Experimental | Drug: TQB2450 Injection + Anlotinib Hydrochloride CapsulesTQB2450 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2450 Injection + Anlotinib Hydrochloride CapsulesAnlotinib Hydrochloride Capsules: multi-target receptor tyrosine kinase inhibitor; TQB2450 injection: programmed cell death protein 1 (PD-1) human monoclonal antibody | Drug | TQB2450 Injection + Anlotinib Hydrochloride Capsules |
Primary outcome
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
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
3 secondary outcomes
Overall response rate (ORR)
Time frame: Up to approximately 36 months
disease control rate
Time frame: Up to approximately 36 months
duration of remission
Time frame: Up to approximately 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Derived from this study: PubMed 40114144Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQB2450 Injection + Anlotinib Hydrochloride Capsules in people with Limited Stage Small Cell Lung Cancer and Not Progressed After First-line Chemoradiotherapy, run by Jinming Yu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin ming Yu, postdoctor (13806406293, sdyujinming@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05942508, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.