Advanced Non-squamous NSCLCPhase 4NCT03778853
Study of Anlotinib in Advanced Non-squamous NSCLC Patients in the Elderly Without Systemic Chemotherapy (ALTER-L006)
A Phase 4 study testing Anlotinib Hydrochloride in people with Advanced Non-squamous NSCLC, run by LanZhou University.
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 70 years and older
- Conditions the study is for
- Advanced Non-squamous NSCLC
- What is being tested?
- Anlotinib Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Dec 2019
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Signed and dated informed consent
- Age：≥70
- 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
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
- 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
No sites are listed yet.
About this study
Official title: An Open, Single-arm, Multi-center Study of Anlotinib in Advanced Non-squamous NSCLC Patients in the Elderly Without Systemic 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 Recruiting 72 patients in the elderly without systemic 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
- Advanced Non-squamous NSCLC
- Being tested
- Anlotinib Hydrochloride
- Keywords
- Non-squamous NSCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib HydrochlorideDrug
Anlotinib Hydrochloride ( 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.
Other Name: AL3818
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib Hydrochloride | Experimental | Anlotinib Hydrochloride p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent Receives: Drug: Anlotinib Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progress free survival (PFS)
Measured: Time Frame: each 42 days up to PD or death(up to 24 months)
Secondary outcomes (5)
OS
Overall Survival (OS)
Measured: From randomization until death (up to 24 months)
DCR
Disease Control Rate (DCR)
Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)
ORR
Objective Response Rate (ORR)
Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Until 30 day safety follow-up visit
EORTC QLQ-C30
use EORTC QLQ-C30(version 3) questionnaire to evaluate the quality of life
Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study startJan 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (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 NSCLCStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LanZhou University
- Sponsor type
- University, hospital or other
- Collaborators
- General Hospital of Ningxia Medical University
- Responsible party
- Principal investigator, Chen Rui, LanZhou University
- Investigators
- xiaoming hou, professor, Principal investigator, LanZhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778853
- Sponsor's protocol ID
- 20180049
- Status last verified
- Dec 2018
- First submitted
- 15 Dec 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. 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 Advanced Non-squamous NSCLC Patients in the Elderly Without Systemic Chemotherapy
- ClinicalTrials.gov ID
- NCT03778853
- Acronym / sponsor ID
- 20180049
- Conditions
- Advanced Non-squamous NSCLC
- Keywords
- Non-squamous NSCLC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- LanZhou UniversityUniversity, hospital or other
- Collaborators
- General Hospital of Ningxia Medical University
- Study start
- Jan 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 19 Dec 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 Recruiting 72 patients in the elderly without systemic 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 Hydrochloride | Experimental | Drug: Anlotinib HydrochlorideAnlotinib Hydrochloride p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Signed and dated informed consent
- Age：≥70
- 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 (14 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 |
|---|---|---|
| Anlotinib HydrochlorideAnlotinib Hydrochloride ( 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. Other Name: AL3818 | Drug | Anlotinib Hydrochloride |
Primary outcome
PFS
Time frame: Time Frame: each 42 days up to PD or death(up to 24 months)
Progress free survival (PFS)
5 secondary outcomes
OS
Time frame: From randomization until death (up to 24 months)
DCR
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
ORR
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Until 30 day safety follow-up visit
EORTC QLQ-C30
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
xiaoming hou, professor principal investigator
LanZhou University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anlotinib Hydrochloride in people with Advanced Non-squamous NSCLC, run by LanZhou University.
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 9 inclusion and 14 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 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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 da zhao, professor (0086-13369287188, Ydfyzhaohon@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Time Frame: each 42 days up to PD or death(up to 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 19 Dec 2018.