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Stage III Non-small-cell Lung CancerPhase 3NCT04325763

A Study of TQB2450 in Subjects With Stage III Non-Small Cell Lung Cancer(NSCLC)

A Phase 3 study testing TQB2450, Anlotinib and TQB2450(blank) in people with Stage III Non-small-cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 36 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

This study is a randomized, double-blind, double-dummy,placebo parallel controlled, multi-centre,phase III clinical trial to evaluate the efficacy and safety of TQB2450 with or without anlotinib compared with placebo as consolidation treatment in subjects with locally advanced/unresectable (Stage III) Non-Small Cell… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Stage III Non-small-cell Lung Cancer
What is being tested?
TQB2450, Anlotinib and TQB2450(blank)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
315 participants
Where
36 sitesChina
Study dates
27 May 2020to Mar 2025
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

  • 18-75 years old ; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
  • Histologically or cytologically confirmed unresectable (Stage III) Non-Small Cell Lung Cancer.
  • At least has one measurable lesion before radiotherapy.
  • At least has one type of platinum-containing chemotherapy, Absence of progression after concurrent/sequential chemoradiotherapy.
  • Adequate laboratory indicators.
  • No pregnant or breastfeeding women, and a negative pregnancy test.
  • Understood and signed an informed consent form.

Who cannot join

  • Squamous cell carcinoma meets following conditions should be excluded:
  • Cavernous lung cancer.
  • Has hemoptysis and maximum daily hemoptysis volume ≥ 2.5ml within 1 month before the first administration.
  • Has received anti-angiogenic drugs or other PD-1 / PD-L1 / CTLA-4 antibody therapy or other immunotherapy against PD-1 / PD-L1 / CTLA-4.
  • Severe hypersensitivity occurs after administration of other monoclonal antibodies.
  • Diagnosed and/or treated additional malignancy within 5 years with the exception of cured basal cell carcinoma of skin ,carcinoma in situ of prostate,and carcinoma in situ of cervix.
Show all 20Show fewer
  • Pathologically confirmed mixed small cell and non-small cell lung cancer.
  • EGFR gene mutations.
  • Has any active autoimmune disease or history of autoimmune disease.
  • After the early stage of chemoradiotherapy, the treatment toxicity ≥ grade 2 is not fully alleviated.
  • Has ≥grade 2 pneumonia.
  • Immunosuppressant or systemic or absorbable local hormone therapy is required to achieve the aim of immunosuppression (dose \> 10mg/ day prednisone or other therapeutic hormones) and is still used within 2 weeks after the first administration.
  • Has multiple factors affecting oral medication.
  • Has active bleeding or a persistent decrease in hemoglobin.
  • Has any bleeding or bleeding events ≥grade 3 in the first 4 weeks before the first administration.
  • 2.Has received anti-angiogenic drugs or other PD-1 / PD-L1 / CTLA-4 antibody therapy or other immunotherapy against PD-1 / PD-L1 / CTLA-4.
  • 14. Has unhealed wounds, fractures, active gastric and duodenal ulcers, positive continuous fecal occult blood, ulcerative colitis in the first 4 weeks before the first administration.
  • 15. Has received NMPA approved anti-tumor drugs or immunomodulatory drugs for systemic treatment within 2 weeks before the first administration.
  • 16.Has a history of a hematological system transplantation or organ transplantation.
  • 17. Has active diverticulitis、peritoneal abscess, intestinal obstruction. 18. Has any serious and/or uncontrollable disease. 19. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Trial locations and contacts

36 sites in 1 country.

Ming Chen contact

0571-88122508

chenming@zjcc.org.cn

36 sites in 1 country

China36 sites, 36 recruiting

  • Anyang Cancer Hospital

    Anyang, Henang, 455000

    Anping Zheng, Master, 0372-2232091, Zhenganping3@aliyun.com

    Anping Zheng, Master

    Recruiting

  • Baoji Central Hospital

    Baoji, Shanxi, 721008

    Yi Geng, Master, 0917-3390834, gengyi0917@126.com

    Yi Geng, Master

    Not yet recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Li Zhang, Master, 010-69151200, zhanglipumch@aliyun.com

    Li Zhang, Master

    Not yet recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410006

    hui Wang, Doctor, 0731-89762231, wanghui710327@163.com

    hui Wang, Doctor

    Not yet recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

    Rongrong Zhou, Doctor, 0731-89753769, 664990095@qq.com

    Rongrong Zhou, Doctor

    Not yet recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

    Peiguo Cao, Doctor, 0731-88618285, caopeiguo@yeah.net

    Peiguo Cao, Doctor

    Not yet recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400000

    Yue Xie, Master, 023-65079227, 344899525@qq.com

    Yue Xie, Master

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400000

    Yuxi Zhu, Doctor, 023-68811360, 724513168@qq.com

    Yuxi Zhu, Doctor

    Not yet recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350000

    Jiangcheng Li, 0591-83660063-5152, Jianchengli62018@126.com

    Jiangcheng Li

    Not yet recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Ming Chen, Doctor, 020-87343543, chenming@zjcc.org.cn

    Ming Chen, Doctor

    Recruiting

  • The First Affiliated Hospital Sun Yat-Sen University

    Guangzhou, Guangdong, 510080

    Yong Bao, Doctor, 020-86668114, baoyong@sysucc.org.cn

    Yong Bao, Doctor

    Not yet recruiting

  • The first Hospital of Zhengjiang Province

    Hangzhou, Zhejiang, 310000

    Sengxiang Yan, Doctor, yansenxiang@zju.edu.cn

    Sengxiang Yan, Doctor

    Not yet recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310005

    Ji Yongling, Doctor, 0571-88128188, jiyl@zjcc.org.cn

    Recruiting

  • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310006

    Bing Xia, Doctor, 0571-56006382, xb0918@hotmail.com

    Bing Xia, Doctor

    Not yet recruiting

  • Zhejiang Hospital

    Hangzhou, Zhejiang, 310013

    Zhibing Wu, Doctor, wu_zhibing@163.com

    Zhibing Wu, Doctor

    Not yet recruiting

  • Zhejiang People's Hospital

    Hangzhou, Zhejiang, 310014

    Xiaodong Liang, Doctor, lxdctopone@sina.com

    Xiaodong Liang, Doctor

    Not yet recruiting

  • Anhui Chest Hospital

    Hefei, Anhui, 230000

    Xuhong Min, 1320722827@qq.com

    Xuhong Min

    Not yet recruiting

  • Huaian First People's Hospital

    Huai'an, Jiangsu, 223300

    Changhua Yu, Master, 1131603215@qq.com

    Changhua Yu, Master

    Not yet recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Yufeng Cheng, Doctor, 0531-82169821, qlcyf@163.com

    Yufeng Cheng, Doctor

    Not yet recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330012

    Junhe Li, Doctor, lijunhe88@163.com

    Junhe Li, Doctor

    Not yet recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210029

    Jifeng Feng, Doctor, 025-83283415, fjif@vip.sina.com

    Jifeng Feng, Doctor

    Not yet recruiting

  • Jiangsu People's Hospital

    Nanjing, Jiangsu, 210029

    Lianke Liu, Doctor, 025-68306428, liulianke@medmail.com.cn

    Lianke Liu, Doctor

    Not yet recruiting

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi, 530200

    Long Chen, master, 0771-5310364, clong6@126.com

    Long Chen

    Not yet recruiting

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang, 315000

    Hongcheng Wu, Master, 0574-87018581, doctorwu1967@126.com

    Hongcheng Wu, Master

    Not yet recruiting

  • Yuebei People's Hospital

    Shaoguan, Guangdong, 512025

    Suming Pan, Master, 0751-6913383

    Suming Pan, Master

    Not yet recruiting

  • The Fourth Hospital of Hebei medical University

    Shijiazhuang, Hebei, 050019

    Jun Wang, Doctor, 0311-86095667, wangjunzr@163.com

    Jun Wang, Doctor

    Not yet recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030000

    Weihua Yang, Master, 0351-4651623, ywh1964@qq.com

    Weihua Yang, Master

    Not yet recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 317000

    Haihua Yang, Master, yhh93181@hotmail.com

    Haihua Yang, Master

    Not yet recruiting

  • Taizhou Central Hospital

    Taizhou, Zhejiang, 318000

    Shenpeng Ying, 13957608158@139.com

    Shenpeng Ying

    Not yet recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

    Qingsong Pang, Doctor, pangqingsong2013@163.com

    Qingsong Pang, Doctor

    Not yet recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

    Desheng Hu, Doctor, 027-87670121, hds_005@163.com

    Desheng Hu, Doctor

    Not yet recruiting

  • Xijing Hospital of Airforce Medical University

    Xi’an, Shanxi, 710000

    Lina Zhao, Doctor, 029-84775425, zhaolinazln@outlook.com

    Lina Zhao, Doctor

    Not yet recruiting

  • First Affiliated Hospital of Xi'anjiantong University

    Xi’an, Shanxi, 710061

    Xiaozhi Zhang, Doctor, 029-85324019, zhang9149@sina.com

    Xiaozhi Zhang, Doctor

    Recruiting

  • Affiliated Hospital of Guangdong Medical University

    Zhangjiang, Guangdong, 524000

    Hualin Chen, Doctor, 0759-2387458, 3549509@qq.com

    Hualin Chen, Doctor

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Hong Ge, Doctor, gehong666@126.com

    Hong Ge, Doctor

    Not yet recruiting

  • The Fifth Affiliated Hospital Sun Yat-Sen University

    Zhuhai, Guangdong, 519000

    Zhigang Liu, Doctor, 0756-2526192, 85172626@qq.com

    Zhigang Liu, Doctor

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Double-blind and Imitation, Placebo Parallel Control, Multicentre Phase III Study of TQB2450 With or Without Anlotinib as Consolidation Treatment in Subjects With Locally Advanced/Unresectable (Stage III) Non-Small Cell Lung Cancer That Have Not Progressed After Prior Concurrent/Sequential Chemoradiotherapy

This study is a randomized, double-blind, double-dummy,placebo parallel controlled, multi-centre,phase III clinical trial to evaluate the efficacy and safety of TQB2450 with or without anlotinib compared with placebo as consolidation treatment in subjects with locally advanced/unresectable (Stage III) Non-Small Cell Lung Cancer that has not progressed after prior concurrent/sequential chemoradiotherapy.

Being tested
TQB2450, Anlotinib, TQB2450(blank), Anlotinib(blank)
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • TQB2450Drug

    TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

  • AnlotinibDrug

    a multi-target receptor tyrosine kinase inhibitor

  • TQB2450(blank)Drug

    Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day

  • Anlotinib(blank)Drug

    Subjects administrated anlotinib (blank) in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)

Study groups in NCT04325763
Study groupRoleWhat they receive
TQB2450+AnlotinibExperimentalTQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 8 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
Receives: Drug: TQB2450; Drug: Anlotinib
TQB2450+Anlotinib(blank)ExperimentalTQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 0 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
Receives: Drug: TQB2450; Drug: Anlotinib(blank)
TQB2450(blank)+Anlotinib(blank)Placebo comparatorTQB2450 0 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 0 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
Receives: Drug: TQB2450(blank); Drug: Anlotinib(blank)

What is being measured

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

  1. Progression Free Survival (PFS) evaluated by Independent Review Committee(IRC)

    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC.

    Measured: up to 33 months

Secondary outcomes (9)

  1. PFS evaluated by Investigator

    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on investigator.

    Measured: up to 33 months

  2. Overall survival (OS)

    OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

    Measured: up to 5 years

  3. Overall response rate (ORR)

    Percentage of participants achieving complete response (CR) and partial response (PR).

    Measured: up to 33 months

  4. Disease control rate（DCR）

    Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).

    Measured: up to 33 months

  5. Duration of response（DOR）

    The time when the participants first achieved complete or partial remission to disease progression.

    Measured: up to 33 months

  6. PFS rate at month 6

    The percentage of PFS at month 6

    Measured: up to 6 months

  7. PFS rate at month 12

    The percentage of PFS at month 12

    Measured: up to 12 months

  8. Biomarkers, such as PD-L1 expression, etc.

    Tissue samples were collected during the screening period for pd-l1 analysis. Blood samples were collected for Tumor Mutation Burden (TMB) test before enrollment (within 7 days before medication) and after exit (±3 days).

    Measured: up to 33 months

  9. Immunogenicity, such as the incidence of ADA

    Degree of the immune response caused by the drug.

    Measured: on day 1, 42, 105, 189 and 90 days after the last administration.

Timeline

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

  1. First posted30 Mar 2020
  2. Study start27 May 2020
  3. Primary completionDec 2022 (estimated)
  4. Study completionMar 2025 (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
315 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04325763
Sponsor's protocol ID
TQB2450-III-05
Status last verified
Mar 2022
First submitted
25 Mar 2020
Last updated
31 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ji Y, Li Q, Chen L, Pang Q, Jiang O, Chen Y, Wang J, Ge H, Cheng Y, Zhou R, Meng X, Min X, Wang H, Yang H, Xie Y, Zheng A, Li J, Xia B, Hu D, Zhang X, Peng F, Li W, Chen B, Li R, Zheng S, Cai L, Li S, Xu Y, Feng W, Lai X, Sheng L, Sun X, Wang Z, Fang M, Yang Y, Yang Y, Chen M. Benmelstobart With or Without Anlotinib After Chemoradiotherapy for Unresectable Non-Small Cell Lung Cancer: The R-ALPS Randomized Clinical Trial. JAMA Oncol. 2026 Oct 29:e263918. doi: 10.1001/jamaoncol.2026.3918. Online ahead of print.

    PubMed 42955021

  • Dong B, Chen L, Pang Q, Jiang O, Ge H, Cheng Y, Zhou R, Meng X, Li J, Zhu X, Wang X, Cao Q, Ji Y, Chen M. TQB2450 with or without anlotinib as maintenance treatment in subjects with locally advanced/unresectable non-small cell lung cancer that have not progressed after prior concurrent/sequential chemoradiotherapy (R-ALPS): study protocol for a randomized, double-blind, placebo-controlled, multicenter phase III trial. Transl Lung Cancer Res. 2024 Oct 31;13(10):2828-2837. doi: 10.21037/tlcr-24-362. Epub 2024 Oct 28.

    PubMed 39507039

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TQB2450, Anlotinib and TQB2450(blank) in people with Stage III Non-small-cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 36 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 7 inclusion and 20 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 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 Ming Chen (0571-88122508, chenming@zjcc.org.cn), 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 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 NCT04325763, which also lists 2 linked publications.

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 31 Mar 2022.

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