Non-squamous NSCLCPhase 4NCT03755869
Study of Anlotinib in Non-squamous NSCLC Patients Who Failed First-Line（ALTER-L020）
A Phase 4 study testing Anlotinib in people with Non-squamous NSCLC, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor celltebiz related kinase -c-Kit kinase. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-squamous NSCLC
- What is being tested?
- Anlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- 29 Nov 2018to Dec 2021
- Phase
- Phase 4
- 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
- Signed and dated informed consent
- Age：18~75 years;
- Subjects with histologically or cytologically confirmed locally advanced and/or advanced NSCLC
- at least two systematic chemotherapy with upwards of 1-line treatments or cannot suffer
- The negative patients in EGFR\&ALK can participate or who positive in EGFR\&ALK, have or have not drug tolerance after the treatment with relative targeted drugs
- Subjects with at least one measurable lesion as defined by RECIST (version 1.1)
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- Expected Survival Time: Over 3 months
- ECOG PS：0-1,
- main organs function is normal
- The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it
Who cannot join
- 1.Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer)
- lung squamous carcinoma
- Other active malignancies requiring treatment
- History of malignancy
- Have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
- Abnormal coagulation (INR>1.5 or PT>ULN+4s or APTT >1.5 ULN); Patients with any physical signs of bleeding diathesis or receiving thrombolysis and anticoagulation
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- take major surgical treatments or have serious trauma before grouping, or the impact of surgery or trauma has been eliminated for less than 14 days.
- Patients with active or unable to control serious infections;
- Patients with Grade II or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc male ≥ 450 ms, female ≥ 470 ms) ; Patients with grade III to IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) <50% (NYHA Classification)
- Patients with non-healing wounds or fractures
- with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus).
- get arterial/venous thrombosis within 12 months, such as cerebrovascular accidents (including temporary ischemic stoke), deevenous thrombosis, and pulmonary embolism
- plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including Cytotoxic Therapy, Signal Transduction Inhibitor, and Immunotherapy
- Patients with cirrhosis, decompensated liver disease, or active hepatitis Have suffered from hemorrhagic disease or coagulation dysfunction
- diagnosed with disease which will severely endanger the security of patients or influence the completion of this research
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shaanxi Provincial Cancer Hospital
Xian, Shanxi, 710000
minhui wu, doctor, 13891825509, wuminhui@126.com
About this study
Official title: An Open, Single-arm, Multi-center Study of Anlotinib in Non-squamous NSCLC Patients Who Failed First-Line Chemotherapy
Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor celltebiz related kinase -c-Kit kinase. In the phase III study, Patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib (12mg, po. qd. on day 1to14 of a 21-day cycle) or placebo, the anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS were 1.4 months and 6.3 months.
Read the detailed description
It is an open, single-arm, multi-center clinical trial conducted in China, and plan to Recruiting103 patients who were progressed after first line systemic therapy and refused/can't tolerate chemotherapy. Patents receive 12mg anlotinib orally daily on day 1to 14 of a 21-day cycle until progression of disease, assess safety and efficacy of the drug.
- Conditions
- Non-squamous NSCLC
- Being tested
- Anlotinib
- Keywords
- Non-squamous NSCLC, Anlotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
Also called AL3818
Anlotinib ( 12mg, QD, PO, d1-14, 21 days per cycle), take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib | Experimental | Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent Receives: Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1
Progress free survival (PFS)
Measured: Baseline until PD or death, whichever occurs first (up to approximately 24 months)
Secondary outcomes (4)
Duration of Overall Survival (OS) as Assessed by the Investigator Using RECIST v1.1
Overall Survival (OS)
Measured: Baseline until death from any cause (up to approximately 24 months)
Disease Control Rate (DCR)as Assessed by the Investigator Using RECIST v1.1
Disease Control Rate (DCR)
Measured: First occurrence of PR or CR until PD or death, whichever occurs first (up to 24 months)
Objective Response Rate (ORR) as Assessed by the Investigator Using RECIST v1.1
Objective Response Rate (ORR)
Measured: Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to 24 months)
Percentage of Participants with Adverse Events
Percentage of Participants with Adverse Events
Measured: Baseline until up to 21 days after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start29 Nov 2018
- Primary completionNov 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-squamous NSCLCStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tang-Du Hospital, Yan'an University Affiliated Hospital
- Responsible party
- Sponsor
- Investigators
- enxiao li, professor, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755869
- Sponsor's protocol ID
- XJTU1AF2018LSK-073
- Status last verified
- Apr 2019
- First submitted
- 26 Nov 2018
- Last updated
- 3 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-arm, Multi-center Study of Anlotinib in Non-squamous NSCLC Patients Who Failed First-Line Chemotherapy
- ClinicalTrials.gov ID
- NCT03755869
- Acronym / sponsor ID
- XJTU1AF2018LSK-073
- Conditions
- Non-squamous NSCLC
- Keywords
- Non-squamous NSCLC, Anlotinib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Tang-Du Hospital, Yan'an University Affiliated Hospital
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 28 Nov 2018 (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.
Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor celltebiz related kinase -c-Kit kinase. In the phase III study, Patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib (12mg, po. qd. on day 1to14 of a 21-day cycle) or placebo, the anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS were 1.4 months and 6.3 months.
Detailed description
It is an open, single-arm, multi-center clinical trial conducted in China, and plan to Recruiting103 patients who were progressed after first line systemic therapy and refused/can't tolerate chemotherapy. Patents receive 12mg anlotinib orally daily on day 1to 14 of a 21-day cycle until progression of disease, assess safety and efficacy of the drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib | Experimental | Drug: AnlotinibAnlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed and dated informed consent
- Age：18~75 years;
- Subjects with histologically or cytologically confirmed locally advanced and/or advanced NSCLC
- at least two systematic chemotherapy with upwards of 1-line treatments or cannot suffer
- The negative patients in EGFR\&ALK can participate or who positive in EGFR\&ALK, have or have not drug tolerance after the treatment with relative targeted drugs
Key exclusion criteria (15 listed)
- 1.Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer)
- lung squamous carcinoma
- Other active malignancies requiring treatment
- History of malignancy
- Have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
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 |
|---|---|---|
| AnlotinibAlso: AL3818Anlotinib ( 12mg, QD, PO, d1-14, 21 days per cycle), take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage. | Drug | Anlotinib |
Primary outcome
Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1
Time frame: Baseline until PD or death, whichever occurs first (up to approximately 24 months)
Progress free survival (PFS)
4 secondary outcomes
Duration of Overall Survival (OS) as Assessed by the Investigator Using RECIST v1.1
Time frame: Baseline until death from any cause (up to approximately 24 months)
Disease Control Rate (DCR)as Assessed by the Investigator Using RECIST v1.1
Time frame: First occurrence of PR or CR until PD or death, whichever occurs first (up to 24 months)
Objective Response Rate (ORR) as Assessed by the Investigator Using RECIST v1.1
Time frame: Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to 24 months)
Percentage of Participants with Adverse Events
Time frame: Baseline until up to 21 days after end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Individual participant dataSharing planned: No
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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.
enxiao li, professor study chair
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anlotinib in people with Non-squamous NSCLC, run by First Affiliated Hospital Xi'an Jiaotong University 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 10 inclusion and 15 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 3 Apr 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 enxiao li, professor (0086-13992819833, doclienxiao@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 (time frame: Baseline until PD or death, whichever occurs first (up to approximately 24 months)). 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 3 Apr 2020.