Lung NeoplasmsNCT03940404
Anlotinib Therapy in Patients With Advanced Lung Cancer.
An observational study of Lung Neoplasms, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
Purpose of the study: To observe the efficacy and safety of Anlotinib Hydrochloric Therapy in Patients with advanced Lung cancer in real world. Subjects of the study: advanced Lung cancer. Methods of the study: This is a real world, prospective, Non-Interventional, Follow-up registration study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Anlotinib Hydrochloride
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- May 2019to Dec 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: advanced lung caner
Who may be able to join
- Patients ≥18 years of age, man or woman, who had to provide written informed consent prior to enrollment.
- Patients who had to have histologically and/or cytologically confirmed NSCLC that failed at least 2 kinds of systemic chemotherapy (third line or beyond), or who will obtain benefit from antiangiogenic therapy after investigator's assessment.
- Eastern Cooperative Oncology Group performance status of 0-2.
Who cannot join
- Contraindication of anlotinib.
- Pregnant or lactating women.
- Other patients who can't enroll after investigator's assessment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First People's Hospital of Hangzhou
Hangzhou, Zhejiang, 300006
Xueqin Chen, +8613735430109, chenlucy1437@aliyun.com
Xueqin Chen
About this study
Official title: Anlotinib Hydrochloride Therapy in Patients With Advanced Lung Cancer: A Real World Study.
Purpose of the study: To observe the efficacy and safety of Anlotinib Hydrochloric Therapy in Patients with advanced Lung cancer in real world.
Subjects of the study: advanced Lung cancer.
Methods of the study:
This is a real world, prospective, Non-Interventional, Follow-up registration study.
Patients will get Anlotinib according to their condition and willingness. Anlotinib will give orally, once daily on days 1-14 of a 21-day cycle. After the procedure, regular follow up after every cycle.
End point:
Primary end point: progression-free survival (PFS). Secondary end points: overall survival (OS), disease control rate (DCR), overall response rate (ORR).
- Conditions
- Lung Neoplasms
- Being tested
- Anlotinib Hydrochloride
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib HydrochlorideDrug
Also called Other intervention depends on the patient's disease
Anlotinib will give orally, once daily on days 1-14 of a 21-day cycle. Dose reduction is allowed.
| Study group | Role | What they receive |
|---|---|---|
| experiment | The patients whose treatment strategy containing anlotinib. Receives: Drug: Anlotinib Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: 1 year
Secondary outcomes (3)
OS
overall survival
Measured: 1 year
ORR
overall response rate
Measured: 1 year
DCR
disease control rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study startMay 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Cttq
- Responsible party
- Sponsor
- Investigators
- Shenglin Ma, Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940404
- Sponsor's protocol ID
- ALOT-LC1
- Status last verified
- May 2019
- First submitted
- 27 Apr 2019
- Last updated
- 7 May 2019
- Results posted
- 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 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anlotinib Hydrochloride Therapy in Patients With Advanced Lung Cancer: A Real World Study.
- ClinicalTrials.gov ID
- NCT03940404
- Acronym / sponsor ID
- ALOT-LC1
- Conditions
- Lung Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Collaborators
- Cttq
- Study start
- May 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 7 May 2019 (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.
Purpose of the study: To observe the efficacy and safety of Anlotinib Hydrochloric Therapy in Patients with advanced Lung cancer in real world.
Subjects of the study: advanced Lung cancer.
Methods of the study:
This is a real world, prospective, Non-Interventional, Follow-up registration study.
Patients will get Anlotinib according to their condition and willingness. Anlotinib will give orally, once daily on days 1-14 of a 21-day cycle. After the procedure, regular follow up after every cycle.
End point:
Primary end point: progression-free survival (PFS). Secondary end points: overall survival (OS), disease control rate (DCR), overall response rate (ORR).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experiment | – | Drug: Anlotinib HydrochlorideThe patients whose treatment strategy containing anlotinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- advanced lung caner
Key inclusion criteria (3 listed)
- Patients ≥18 years of age, man or woman, who had to provide written informed consent prior to enrollment.
- Patients who had to have histologically and/or cytologically confirmed NSCLC that failed at least 2 kinds of systemic chemotherapy (third line or beyond), or who will obtain benefit from antiangiogenic therapy after investigator's assessment.
- Eastern Cooperative Oncology Group performance status of 0-2.
Key exclusion criteria (3 listed)
- Contraindication of anlotinib.
- Pregnant or lactating women.
- Other patients who can't enroll after investigator's assessment.
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 HydrochlorideAlso: Other intervention depends on the patient's diseaseAnlotinib will give orally, once daily on days 1-14 of a 21-day cycle. Dose reduction is allowed. | Drug | experiment |
Primary outcome
PFS
Time frame: 1 year
progression-free survival
3 secondary outcomes
OS
Time frame: 1 year
ORR
Time frame: 1 year
DCR
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- 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.
Shenglin Ma principal investigator
First People's Hospital of Hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms, run by First People's Hospital of Hangzhou 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 3 inclusion and 3 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 7 May 2019. 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.
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 Xueqin Chen (+8613735430109, chenlucy1437@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 1 year). 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 7 May 2019.