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Small Cell Lung Cancer Limited StagePhase 3NCT06469879

A Clinical Study of TQB2450 Combined With Anlotinib in Limited-Stage Small Cell Lung Cancer Patients

A Phase 3 study testing TQB2450+Anlotinib in people with Small Cell Lung Cancer Limited Stage, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 16 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of TQB2450 in combination with anlotinib as maintenance therapy in patients with limited-stage small cell lung cancer who have not progressed after chemoradiotherapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Small Cell Lung Cancer Limited Stage
What is being tested?
TQB2450+Anlotinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
358 participants
Where
16 sitesChina
Study dates
Sep 2024to Sep 2026
Phase
Phase 3
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 subjects voluntarily joined the study, signed the informed consent, and the compliance was good;
  • Age: 18~75 years old (when signing the informed consent form); Eastern Cooperative Oncology Group Performance Status score: 0-1 points; expected survival of more than 6 months; weight > 40 kg;
  • Pathologically confirmed patients with limited stage small cell lung cancer (according to the Veterans Administration Lung Study Group (VALG) stage);
  • There was no evidence of metastatic disease by diagnostic quality enhanced CT of the neck, chest, abdomen, and pelvic cavity, and craniocerebral plain scan plus enhanced MRI (PET-CT is recommended before chemoradiotherapy. Bone scan should be performed if PET-CT is not performed before chemoradiotherapy. PET-CT must be performed during the screening period after chemoradiotherapy to rule out metastasis.);
  • It is anticipated that no tumor resection will be required during the study（Patients who are not suitable for surgery or those who do not want surgery can be treated);
  • Receive the chemoradiotherapy regimen prescribed below, unless an alternative is acceptable after consultation with the investigator:
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  • Four cycles of platinum-containing chemotherapy with concurrent or sequential radiotherapy were received, and these treatments had to be completed within 1 to 42 days of randomization and the first administration of the study drug;
  • According to the standard treatment regimen at each study center, chemotherapy regimens must contain cisplatin/carboplatin drugs and etoposide administered intravenously
  • For the standard Quaque Die radiotherapy regimen, the total radiation dose received was 60 Gy±10% (6-week regimen), and for the hyperfractionated Bis in die radiotherapy regimen, the total radiation dose received was 45 Gy (3-week regimen), and the dose was calculated based on the planned target area (PTV). Research centers are encouraged to follow the following doses of radiation to organs at risk：
  • c.1 Average lung dose <20 Gy and/or V20 must be <35% c.2 Cardiac V50 <25% d. If synchronous Cardiac resynchronization therapy is used, chest radiotherapy must be started no later than the first day of the 3rd cycle of chemotherapy; e. If sequential radiotherapy is used, thoracic radiotherapy should be preceded by at least 2 cycles of induction chemotherapy, with no more than 35 days between the end of the chemotherapy cycle and the start of radiotherapy;
  • Precision radiotherapy techniques such as three-dimensional conformal radiotherapy, conformal intensity modulated radiotherapy and tomographic radiotherapy are adopted;
  • Patients receiving radical platinum-based chemoradiotherapy must achieve complete response, partial response, or stable disease without disease progression;
  • Prophylactic brain radiotherapy (PCI) is permitted according to the judgment of the investigator and the standard treatment at each study center, and must be performed after the completion of Cardiac resynchronization therapy, but it is allowed to be targeted at the last chemotherapy;
  • The patient provided tumor tissue as far as possible for Programmed cell Death ligand 1 (PD-L1) expression level determination. Any available tumor tissue sample can be submitted: histology or cytology (if tissue samples are not available). Pathology reports of these specimens must also be provided;
  • The patient was confirmed to have at least one measurable lesion according to RECIST 1.1 criteria prior to chemoradiotherapy;
  • Having an adequate Pulmonary function test, defined as Forced expiratory volume in one second > 50% of predicted normal expiratory volume and Diffusing capacity of the lung for carbon monoxide (DLCO) > 40% of predicted normal. For subjects without diffusing capacity of the lungs for carbon monoxide measurements, adequate oxygen transport is considered if the pulse oxygen saturation (O2 saturation) measured in indoor air is ≥ 90%.

Who cannot join

  • Tumor disease and history
  • Present or present with other malignant tumors within 3 years. The following two conditions can be included: 5 consecutive years of disease-free survival (DFS) without any treatment for other malignancies; Cured of thyroid cancer, Cervical carcinoma in situ, Non-melanoma skin cancer and superficial bladder tumors【Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basal membrane)】;
  • Complex small cell lung cancer confirmed by histopathology or cytopathology;
  • Subjects with known central nervous system metastatic and/or cancerous meningitis;
  • Malignant pleural effusion and pericardial effusion；
  • Patients whose imaging (CT or MRI) shows that the tumor has invaded an important blood vessel or who are judged by the investigator to be highly likely to invade an important blood vessel during subsequent studies and cause a fatal hemorrhage;
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  • Previous antitumor therapy
  • Within 2 weeks prior to the start of the study treatment, the patients were treated with proprietary Chinese medicines with anti-tumor indications specified in theNational Medical Products Administration approved drug specification (Including compound cantharidin capsule, Kangai injection, Kanglaite capsule/injection, Aidi injection, Brucea oil injection/capsule, Xiaoaiping tablet/injection, Huachansu capsule and so on);
  • Patients who have received immunomodulatory drugs (e.g., interleukin-2, thymosin, lentinan, etc.) within 30 days before starting treatment；
  • Prior treatment with an anti-programmed death-1, anti-Programmed cell death 1 ligand 1, or anti-Programmed death ligand-2 drug or against another irritating or co-inhibitory T cell receptor (e.g. cytotoxic T lymphocyte-associated antigen-4, OX 40, TNFRSF9, 4-1BB)；
  • In the past, he used bevacizumab,Anlotinib, Apatinib and other anti-angiogenic drugs；
  • Received more than 4 courses of chemotherapy。Chemotherapy regiments other than etoposide and platinum are not allowed；
  • Unmitigated toxic effects above Common Terminology Criteria for Adverse Events grade 1 due to any prior treatment（Hearing loss, hair loss, fatigue and abnormal lymphocyte count due to prior chemoradiotherapy were not included）；
  • Subjects with ≥ grade 2 pulmonary inflammation after prior chemoradiotherapy;
  • Combined disease and history
  • Cirrhosis, active hepatitis*:
  • Active hepatitis（Hepatitis B reference: HBsAg positive, and Hepatitis B virus DNA detection value exceeds the upper limit of normal value; Hepatitis C reference: Hepatitis C virus antibody positive and Hepatitis C (HCV) virus titer test values above the upper limit of normal); Note: Participants who are eligible for enrollment, hepatitis B surface antigen positive or core antibody positive, and hepatitis C patients need continuous antiviral therapy to prevent virus activation.
  • Patients with renal failure requiring hemodialysis or peritoneal dialysis have pre-existing or existing nephrotic syndrome or chronic nephritis
  • Cardio-cerebrovascular abnormalities:
  • c.1 Have grade 2 myocardial ischemia or myocardial infarction, arrhythmia (including QT Interval Correction ≥450ms in men, QT Interval Correction ≥470ms in women), and grade 2 congestive heart failure (NYHA rating); c.2 Severe arterial/venous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc., occurred within 6 months; c.3 After two or more medications, blood pressure control remained unsatisfactory (systolic ≥150 mmHg or diastolic ≥90 mmHg) d. History of immunodeficiency: d.1 A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; d.2 Active autoimmune disease requiring systemic treatment (such as use of disease-modifying drugs, corticosteroids, or immunosuppressants) occurred within 2 years prior to study treatment initiation(Such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; Subjects with asthma requiring medical intervention with bronchodilators were not included). Hormone replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) may not be considered systemic treatment; e. Have been diagnosed with an immune deficiency or are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose >10mg/ day prednisone or other therapeutic hormone) and continue to use within 2 weeks prior to initial administration; f. Patients with active tuberculosis within 1 year prior to enrollment; Participants with a history of active pulmonary tuberculosis infection before 1 year were required to provide clear evidence of cure. If tuberculosis was suspected during the screening period, the patients could be enrolled only after being excluded by chest radiography or chest CT, sputum and clinical symptoms;
  • Study live attenuated vaccine vaccination history within 28 days before the start of treatment or planned live attenuated vaccine vaccination during the study period;
  • Had participated in other anti-tumor drug clinical trials within 4 weeks before the first drug use, and only those who had not used drugs were not subject to the 4-week time limit.

Trial locations and contacts

16 sites in 1 country.

Jinming Yu, Doctor contact

13806406293

sdyujinming@126.com

16 sites in 1 country

China16 sites

  • AnYang Tumor Hospital

    Anyang, Henan, 455001

    Yaowen Zhang, Doctor, 15837207287, zhangyaowen621@126.com

  • Beijing Chest Hospital, Capital Medical University

    Beijing, 101149

    Tongmei Zhang, Doctor, 13683016715, tongmeibj@163.com

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Hui Wang, Doctor, 13973135460, wanghui@hnca.org.cn

    Huai Liu, Doctor, 18874831511, liuhuai@hnca.org.cn

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    YongLing Ji, Doctor, 13958085251, jiyl@zjcc.org.cn

  • Harbin Medical University cancer hospital

    Harbin, Heilongjiang, 150081

    BaoGang Liu, Doctor, 13804552752, baogangliu1962@163.com

  • Anhui Provincial Hospital

    Hefei, Anhui, 23002

    Dong Qian, Doctor, 18202269589, qiandong@ustc.edu.cn

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250063

    Yufeng Cheng, Doctor, 18560081666, qlcyf@163.com

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Jinming Yu, Doctor, 13806406293, sdyujinming@126.com

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

    Pengfei Sun, Doctor, 13919485464, sunpengfeiby@163.com

  • Guangxi Medical University Cancer Hospital

    Nanjing, Guangxi, 530021

    Xinbin Pan, Master, 13471171468, panxinbin@gxmu.edu.cn

  • The Second People's Hospital of Neijiang

    Neijiang, Sichuan, 641199

    Yu Liu, Master, 13698308655, 13278258@qq.com

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110002

    Bo Jin, Doctor, 13604923020, jb_cmu@126.com

  • Shanxi Provincial Cancer Hpspital

    Taiyuan, Shanxi, 030000

    Jie Li, Master, 18635169066, lijie942003@163.com

  • Tangshan People's Hospital

    Tangshan, Hebei, 63001

    Junquan Yang, Doctor, 19131829092, 13313059092@163.com

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

    Xiaomin Dang, Doctor, 18991232795, dxming112@163.com

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441021

    Tienan Yi, Master, 13871658799, 1721905183@qq.com

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase III 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

This study is a randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of TQB2450 in combination with anlotinib as maintenance therapy in patients with limited-stage small cell lung cancer who have not progressed after chemoradiotherapy.

Being tested
TQB2450+Anlotinib, TQB2450 placebo + Anlotinib placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQB2450+AnlotinibDrug

    TQB2450 injection test group, 1200 mg/time, strength: 600mg/20 mL, intravenous drip, day 1, every 3 weeks. Anlotinib hydrochloride capsules: 8 mg/time, strength: 10mg/capsule, 8mg/capsule, 6mg/capsule., 1 time a day (QD), continuous use for 2 weeks and stop for 1 week.

    TQB2450 Injection Placebo (control group): 0 mg/time, strength: 0mg/20 mL, Intravenous Drip, Day 1, every 3 weeks. Anlotinib hydrochloride capsule placebo: 0 mg/time, strength: 0mg/capsule, 1 time a day (QD), continuous use for 2 weeks and stop for 1 week.

  • TQB2450 placebo + Anlotinib placeboDrug

    No drug substance is contained

Study groups in NCT06469879
Study groupRoleWhat they receive
TQB2450+AnlotinibExperimentalTQB2450 injection: 1200 mg/time, intravenous infusion, day 1, every 3 weeks (Q3W); Anlotinib hydrochloride capsules: 8 mg/time, once a day (QD), for 2 weeks, stop for 1 week, oral before breakfast; (The starting dose of anlotinib hydrochloride is 8 mg, and an upward adjustment to 10 mg is allowed after two cycles.)
Receives: Drug: TQB2450+Anlotinib
TQB2450 placebo + anlotinib placeboPlacebo comparatorTQB2450 injection placebo: 0 mg/time, intravenous drip, day 1; anlotinib hydrochloride capsule placebo: 0 mg/time, once a day (QD), for 2 consecutive weeks, stop for 1 week, oral administration before breakfast.
Receives: Drug: TQB2450 placebo + Anlotinib placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) evaluated by the Independent Review Committee (IRC)

    Random to the time of disease progression or death.

    Measured: up to 33 months

Secondary outcomes (6)

  1. Progression-free survival (PFS) evaluated by researcher

    Random to the time of disease progression or death.

    Measured: up to 33 months

  2. Overall survival (OS)

    Time from random to death.

    Measured: About 5 years

  3. Objective mitigation rate (ORR)

    The proportion of patients whose tumor volume shrinks to the predetermined value and can maintain the minimum time limit is the sum of the proportion of complete remission (CR) and partial remission (PR).

    Measured: up to 33 months

  4. Remission duration (DOR)

    The period when the first judgment is complete or partial remission until it is found to be the progress of the disease.

    Measured: up to 33 months

  5. Disease control rate

    The number of cases with remission (PR+CR) and disease stability (SD) after treatment as a percentage of the number of evaluable cases.

    Measured: up to 33 months

  6. No progress survival PFS rate in 12 or 24 months

    If the tumor progresses or dies in 12 or 24 months, the time is from the beginning of the follow-up to the event. The proportion of all subjects who have not yet occurred at a certain time is called (no progress) survival rate.

    Measured: up to 33 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2024
  2. Study startSep 2024 (estimated)
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
358 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06469879
Sponsor's protocol ID
TQB2450-ALTN-III-01
Status last verified
Jun 2024
First submitted
17 Jun 2024
Last updated
1 Jul 2024
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TQB2450+Anlotinib in people with Small Cell Lung Cancer Limited Stage, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 16 sites 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 16 inclusion and 22 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 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Jinming Yu, Doctor (13806406293, sdyujinming@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) evaluated by the Independent Review Committee (IRC) (time frame: up to 33 months). 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 NCT06469879, 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 1 Jul 2024.

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