Advanced Non-squamous Cell Non-small Cell Lung CancerPhase 3NCT04439890
A Efficacy and Safety Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy as First-line Treatment in Subjects With Advanced Non-squamous Cell Non-small Cell Lung Cancer
A Phase 3 study testing Anlotinib hydrochloride capsule, Carboplatin injection and Pemetrexed disodium f Injection in people with Advanced Non-squamous Cell Non-small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 59 sites in China.
Trial summary
This is a randomized, double-blind, multicenter phase III clinical study to evaluate efficacy and safety of anlotinib hydrochloride capsule combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in subjects with advanced non-squamous cell non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Non-squamous Cell Non-small Cell Lung Cancer
- What is being tested?
- Anlotinib hydrochloride capsule, Carboplatin injection and Pemetrexed disodium f Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 369 participants
- Where
- 59 sitesChina
- Study dates
- 8 Aug 2019to 31 Dec 2021
- 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
- 1. Local advanced (stage IIIB / ⅢC), metastatic or recurrent (stage IV) non-squamous cell non-small cell lung cancer, has at least one measurable lesion.
- 2. EGFR, ALK, and ROS1 test results are negative. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, life expectancy≥ 12 weeks.
- 4. Has not received systemic anti-tumor treatment for advanced disease. 5.Adequate organ system function. 6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ; No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
- 7. Understood and signed an informed consent form.
Who cannot join
- 1.Other histopathological types of non-small cell lung cancer. 2.Has received VEGF pathway targeted therapy including anlotinib and bevacizumab.
- 3. Has multiple factors affecting oral medication. 4. Has symptomatic brain metastases. 5. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- 6. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.
- 7. Has any severe and / or uncontrolled diseases. 8. Has any bleeding symptoms or treated with anticoagulants or vitamin K antagonists.
- 9.Has received surgery, or unhealed wounds within 4 weeks before the first administration.
- 10. Has hemoptysis within 28 days before randomization. 11. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear.
Show all 9Show fewer
- 12. Has arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident including transient ischemic attack, deep vein thrombosis and pulmonary embolism.
- 13. Has psychotropic substances abuse or a mental disorder. 14. Have a history of immunodeficiency. 15. Has received allogeneic organ transplantation, hematopoietic stem cell transplantation or bone marrow transplantation.
- 16. Has other malignancy. 17.Has participated in other anticancer drug clinical trials within 4 weeks. 18.According to the judgement of the researchers, there are other factors that may lead to the termination of the study.
Trial locations and contacts
59 sites in 1 country.
59 sites in 1 country
China59 sites, 59 recruiting
- Recruiting
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 100010
Baolan Li, Doctor, libaolan1109@163.com
Baolan Li, Doctor
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100010
Baoshan Cao, Doctor, caobaoshan0711@aliyun.com
Baoshan Cao, Doctor
- Recruiting
The Sixth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100010
Zhihai Han, Doctor, hanzhihai@souhu.com
Zhihai Han, Doctor
- Recruiting
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100010
Yi Zhang, Doctor, steven9130@sina.com
Yi Zhang, Doctor
- Recruiting
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Li Zhang, Doctor, zhanglipumch@aliyun.com
Li Zhang, Doctor
- Recruiting
The Second Hospital of Jilin University
Changchun, Jilin, 130011
Yarong Li, Doctor, Doctor.lyr@163.com
Yarong Li, Doctor
- Recruiting
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Chengping Hu, Doctor, huchengp@126.com
Chengping Hu, Doctor
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 425001
Jianhua Chen, Doctor, cjh_1000@163.com
Jianhua Chen, Doctor
- Recruiting
Changzhou Second People's Hospital
Changzhou, Jiangsu, 213004
Mingxia Yang, Doctor, cougermx@126.com
Mingxia Yang, Doctor
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 431338
Hong Chen, Doctor, 417335669@qq.com
Hong Chen, Doctor
- Recruiting
The Second Affiliated Hospital of Chinese PLA Army Medical University
Chongqing, Chongqing Municipality, 431338
Zhi Xu, Doctor, xu_zhi999@163.com
Zhi Xu, Doctor
- Recruiting
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116001
Yang Zhang, Doctor, zydley@163.com
Yang Zhang, Doctor
- Recruiting
Dazhou Central Hospital
Dazhou, Sichuan, 635000
Fudao Wu, Doctor, wfde@163.com
Fudao Wu, Doctor
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Wu Zhuang, Doctor, zhuangwu2008@126.com
Wu Zhuang, Doctor
- Recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510010
Zhong Lin, Doctor, linzhong123@163.com
Zhong Lin, Doctor
- Recruiting
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 510010
Ying Ding, Doctor, dy61321157@163.com
Ying Ding, Doctor
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510289
Minhui Wang, Doctor, wmingh@mail.sysu.edu.cn
Minhui Wang, Doctor
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310002
Xinmin Yu, Doctor, yuxm@zjcc.org.cn
Xinmin Yu, Doctor
- Recruiting
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Jianying Zhou, Doctor, Drzjy@163.com
Jianying Zhou, Doctor
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Wen Li, Doctor, liwenzjhz0408@163.com
Wen Li, Doctor
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Yan Yu, Doctor, gpyuyan@163.com
Yan Yu, Doctor
- Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230001
Hui Zhao, Doctor, dy61321157@163.com
Hui Zhao, Doctor
- Recruiting
Anhui Chest Hospital
Hefei, Anhui, 230011
Xuhong Min, Doctor, 13855179548@163.com
Xuhong Min, Doctor
- Recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Neimenggu, 010010
Xiuhua Fu, Doctor, 1499521269@qq.com
Xiuhua Fu, Doctor
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Xiuwen Wang, Doctor, wangxiuwen@csco.org.cn
Xiuwen Wang, Doctor
- Recruiting
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272000
Shucheng Ye, Doctor, 18678766862@163.com
Shucheng Ye, Doctor
- Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650011
Gaofeng Li, Doctor, ligaofenghl@126.com
Gaofeng Li, Doctor
- Recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Hongmei Yue, Doctor, 13893265368@163.com
Hongmei Yue, Doctor
- Recruiting
Lianyungang First People's Hospital
Lianyungang, Jiangsu, 222001
Jiashu Li, Doctor, lissm1118@sina.com
Jiashu Li, Doctor
- Recruiting
Linfen Central Hospital
Linfen, Shanxi, 314000
Yanli Li, Doctor, 1270005400@qq.com
Yanli Li, Doctor
- Recruiting
Linyi Cancer Hospital
Linyi, Shandong, 277739
Jianhua Shi, Doctor, lyzlyygcp@163.com
Jianhua Shi, Doctor
- Recruiting
First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000
Yanzhen Guo, Doctor, guoyanzhen177@163.com
Yanzhen Guo, Doctor
- Recruiting
Meizhou People's Hospital
Meizhou, Guangdong, 514798
Guowu Wu, Doctor, wwwflay@126.com
Guowu Wu, Doctor
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Wei Zhang, Doctor, 13707089183@163.com
Wei Zhang, Doctor
- Recruiting
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530021
Qitao Yu, Doctor, yqt178@163.com
Qitao Yu, Doctor
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226691
Jian Feng, Doctor, jfeng68@126.com
Jian Feng, Doctor
- Recruiting
Ruian People's Hospital
Ruian, Zhejiang, 325000
Zongxiao Shangguan, Doctor, sangxao0707@163.com
Zongxiao Shangguan, Doctor
- Recruiting
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Jialei Wang, Doctor, luwangjialei@hotmail.com
Jialei Wang, Doctor
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Baohui Han, Doctor, 021-22200000-3138
Baohui Han, Doctor
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
Yunpeng Liu, Doctor, cmu_trial@163.com
Yunpeng Liu, Doctor
- Recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042
Weijun Bai, Doctor, 18900917878@163.com
Weijun Bai, Doctor
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051
Ming He, Doctor, heming6699@sina.com
Ming He, Doctor
- Recruiting
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 300409
Shouan Ren, Doctor, renshouan@163.com
Shouan Ren, Doctor
- Recruiting
Tengzhou Central People's Hospital
Tengzhou, Shandong, 277500
Lin Li, Doctor, lilingtz@163.com
Lin Li, Doctor
- Recruiting
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300010
Xun Zhang, Doctor, zhangxun69@163.com
Xun Zhang, Doctor
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300011
Diansheng Zhong, Doctor, zhongdsh@hotmail.com
Diansheng Zhong, Doctor
- Recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Dingzhi Huang, Doctor, dingzhih72@163.com
Dingzhi Huang, Doctor
- Recruiting
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830011
Zhigang Han, Doctor, 1378213986@qq.com
Zhigang Han, Doctor
- Recruiting
Huazhong University of Science Tongji Hospital, Tongji Medical College
Wuhan, Hubei, 430010
Yuan Chen, Doctor, 18678766862@163.com
Yuan Chen, Doctor
- Recruiting
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, 242400
Zhiwei Lu, Doctor, sduzhiwei@sina.com
Zhiwei Lu, Doctor
- Recruiting
Gansu Wuwei Tumor Hospital
Wuwei, Gansu, 733000
Zhengguo Li, Doctor, lizhengguo190@sina.com
Zhengguo Li, Doctor
- Recruiting
Tangdu Hospital, The Fourth Military Medical University of PLA
Xi’an, Shanxi, 710038
Tao Zhang, Doctor, zhangft@fmmu.edu.com
Tao Zhang, Doctor
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 721001
Manxiang Li, Doctor, manxiangli@hotmail.com
Manxiang Li, Doctor
- Recruiting
Xingtai People's Hospital
Xingtai, Hebei, 540000
Jun Guo, Doctor, guojun_868@sina.com
Jun Guo, Doctor
- Recruiting
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, 455001
Hongrui Niu, Doctor, 1163458431@qq.com
Hongrui Niu, Doctor
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221003
Xiuping Du, Doctor, 1422363662@qq.com
Xiuping Du, Doctor
- Recruiting
Subei People's Hospital
Yangzhou, Jiangsu, 211400
Xingxiang Xu, Doctor, Xuxxu63@sina.com
Xingxiang Xu, Doctor
- Recruiting
Ningxia Medical University General Hospital
Yinchuan, Ningxia, 750001
Wei Zhou, Doctor, zhw0306@126.com
Wei Zhou, Doctor
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 475000
Yanqiu Zhao, Doctor, 13938252350@163.com
Yanqiu Zhao, Doctor
About this study
Official title: A Randomized, Double-blind, Multicenter Phase III Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy as First-line Treatment in Subjects With Advanced Non-squamous Cell Non-small Cell Lung Cancer
This is a randomized, double-blind, multicenter phase III clinical study to evaluate efficacy and safety of anlotinib hydrochloride capsule combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in subjects with advanced non-squamous cell non-small cell lung cancer.
- Being tested
- Anlotinib hydrochloride capsule, Carboplatin injection, Pemetrexed disodium f Injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib hydrochloride capsuleDrug
Anlotinib hydrochloride capsule 12mg given orally 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)
Carboplatin injectionDrug
Carboplatin injection AUC 5mg/mL/min, intravenous drip, on Day 1 in 21-day cycle.
Pemetrexed disodium f InjectionDrug
Pemetrexed disodium f Injection 500mg / m2, intravenous drip, on Day 1 in 21-day cycle.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib hydrochloride capsule + chemotherapy | Experimental | Anlotinib hydrochloride capsule 12mg given orally 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) + Carboplatin injection (AUC 5mg/mL/min, intravenous drip, on Day 1) + Pemetrexed disodium f Injection (500mg / m2, intravenous drip, on Day 1). Receives: Drug: Anlotinib hydrochloride capsule; Drug: Carboplatin injection; Drug: Pemetrexed disodium f Injection |
| Placebo + chemotherapy | Placebo comparator | Placebo given orally 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) + Carboplatin injection (AUC 5mg/mL/min, intravenous drip, on Day 1) + Pemetrexed disodium f Injection (500mg / m2, intravenous drip, on Day 1). Receives: Drug: Carboplatin injection; Drug: Pemetrexed disodium f Injection; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Measured: up to 48 weeks
Secondary outcomes (4)
Overall response rate (ORR) assessed by Independent Review Committee (IRC)
Percentage of subjects achieving complete response (CR) and partial response (PR) based on IRC.
Measured: up to 48 weeks
Overall survival (OS)
OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
Measured: up to 48 weeks
Disease control rate（DCR）
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Measured: up to 48 weeks
Disease of Response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Measured: up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start8 Aug 2019
- Primary completion1 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-squamous Cell Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 369 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439890
- Sponsor's protocol ID
- ALTN-03-III-01
- Status last verified
- Jun 2020
- First submitted
- 18 Jun 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter Phase III Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy as First-line Treatment in Subjects With Advanced Non-squamous Cell Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04439890
- Acronym / sponsor ID
- ALTN-03-III-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 369 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 19 Jun 2020 (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.
This is a randomized, double-blind, multicenter phase III clinical study to evaluate efficacy and safety of anlotinib hydrochloride capsule combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in subjects with advanced non-squamous cell non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib hydrochloride capsule + chemotherapy | Experimental | Drug: Anlotinib hydrochloride capsule, Drug: Carboplatin injection, Drug: Pemetrexed disodium f InjectionAnlotinib hydrochloride capsule 12mg given orally 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) + Carboplatin injection (AUC 5mg/mL/min, intravenous drip, on Day 1) + Pemetrexed disodium f Injection (500mg / m2, intravenous drip, on Day 1). |
| Placebo + chemotherapy | Placebo comparator | Drug: Carboplatin injection, Drug: Pemetrexed disodium f Injection, Drug: PlaceboPlacebo given orally 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) + Carboplatin injection (AUC 5mg/mL/min, intravenous drip, on Day 1) + Pemetrexed disodium f Injection (500mg / m2, intravenous drip, on Day 1). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Local advanced (stage IIIB / ⅢC), metastatic or recurrent (stage IV) non-squamous cell non-small cell lung cancer, has at least one measurable lesion.
- 2. EGFR, ALK, and ROS1 test results are negative. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, life expectancy≥ 12 weeks.
- 4. Has not received systemic anti-tumor treatment for advanced disease. 5.Adequate organ system function. 6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ; No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
- 7. Understood and signed an informed consent form.
Key exclusion criteria (9 listed)
- 1.Other histopathological types of non-small cell lung cancer. 2.Has received VEGF pathway targeted therapy including anlotinib and bevacizumab.
- 3. Has multiple factors affecting oral medication. 4. Has symptomatic brain metastases. 5. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- 6. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.
- 7. Has any severe and / or uncontrolled diseases. 8. Has any bleeding symptoms or treated with anticoagulants or vitamin K antagonists.
- 9.Has received surgery, or unhealed wounds within 4 weeks before the first administration.
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 |
|---|---|---|
| Anlotinib hydrochloride capsuleAnlotinib hydrochloride capsule 12mg given orally 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) | Drug | Anlotinib hydrochloride capsule + chemotherapy |
| Carboplatin injectionCarboplatin injection AUC 5mg/mL/min, intravenous drip, on Day 1 in 21-day cycle. | Drug | Anlotinib hydrochloride capsule + chemotherapy, Placebo + chemotherapy |
| Pemetrexed disodium f InjectionPemetrexed disodium f Injection 500mg / m2, intravenous drip, on Day 1 in 21-day cycle. | Drug | Anlotinib hydrochloride capsule + chemotherapy, Placebo + chemotherapy |
| PlaceboPlacebo | Drug | Placebo + chemotherapy |
Primary outcome
Progression free survival (PFS)
Time frame: up to 48 weeks
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
4 secondary outcomes
Overall response rate (ORR) assessed by Independent Review Committee (IRC)
Time frame: up to 48 weeks
Overall survival (OS)
Time frame: up to 48 weeks
Disease control rate（DCR）
Time frame: up to 48 weeks
Disease of Response (DOR)
Time frame: up to 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
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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.
59 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anlotinib hydrochloride capsule, Carboplatin injection and Pemetrexed disodium f Injection in people with Advanced Non-squamous Cell Non-small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 59 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 4 inclusion and 9 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 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: up to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2020.