Small Cell Lung CancerPhase 4NCT03890055
Clinical Study of First-line Treatment of Small Cell Lung Cancer (SCLC) With Anlotinib Hydrochloride
A Phase 4 study testing Anlotinib Hydrochloride in people with Small Cell Lung Cancer, run by Chifeng Municipal Hospital.
Trial summary
This study was designed to investigate the efficacy and side effects of combining erlotinib with classical EC/EP chemotherapy regimens. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Anlotinib Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 1 Oct 2020
- 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
- patients 18-75 years of age.
- A metastatic or recurrent advanced SCLC confirmed by histology or cytology and did not receive any other treatment;
- a measurable disease
- an Eastern Cooperative Oncology Group PS of 0-1;
- an estimated survival duration of >6 months;
Who cannot join
- Have used erlotinib or other anti-vascular targeted drugs (eg, Endo, bevacizumab, etc.)2. Patients who have been treated with chemotherapy or radiotherapy for previous tumors.3.Have appeared or merged with other tumors within 5 years.4.Patients with no measurable lesions; 5.any severe and uncontrolled disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Study of First-line Treatment of Small Cell Lung Cancer (SCLC) With Anlotinib Hydrochloride in in Combination With EC/EP
This study was designed to investigate the efficacy and side effects of combining erlotinib with classical EC/EP chemotherapy regimens.
Read the detailed description
Lung cancer is a common malignant tumor that poses a serious threat to human health. Small cell lung cancer accounts for about 20% of lung cancer. Precision medicine has recently been perfectly interpreted in many tumor types, but the treatment of small cell lung cancer is still bleak. The EC/EP regimen is the most classic chemotherapy regimen for small cell lung cancer with good results but is prone to drug resistance. In 2018, with the development of immunotargeting therapy, small molecule multi-target anti-angi drugs, PARP inhibitors, new chemotherapy drugs, etc., the treatment of small cell lung cancer has ushered in a new dawn. As a kind of highly selective multi-target anti-angiogenic TKI drugs,Anlotinib Hydrochloride is a kind of 1.1 innovative drugs with independent intellectual property rights in China, mainly acting on VEGFR, PDGFR, FGFR and c-Kit. The latest ALTER1202 study confirms that anlotinib is significantly improved for PSC and ORR in SCLC patients who have previously received at least 2-line chemotherapy. OS data is not yet mature, but the benefits of the anlotinib group were observed. The adverse effects of anlotinib were consistent with expectations, no new adverse events were found, and safety was tolerated. Nowadays, the effective combination of traditional chemical therapy with molecular targeting and immunotherapy is the future development direction of lung cancer treatment. Therefore, this topic is designed to combine the efficacy of safety and safety with the treatment of anlotinib with the classic EC/EP chemotherapy regimen. Expected to get longer PFS and OS for patient benefit.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Anlotinib Hydrochloride
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib HydrochlorideDrug
Also called Focusv
Best supportive care
| Study group | Role | What they receive |
|---|---|---|
| Clinical trial group | Experimental | （Carboplatin/cisplatin + etoposide）+ （Anlotinib Hydrochloride 12 mg/day ，Each cycle was defined as 2 weeks on-treatment fol- lowed by 1 week off-treatment）, after 4-6 cycles of treatment, the treatment was continued with anlotinib until disease progression. 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: nine months
Secondary outcomes (4)
OS
overall survival
Measured: 12 months
ORR
Objective Response Rate
Measured: 12 months
DCR
disease control rate
Measured: 12 months
safety assessed by Adverse reactions
Adverse reactions
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung CancerStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chifeng Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890055
- Sponsor's protocol ID
- B19267BT
- Status last verified
- Mar 2019
- First submitted
- 24 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han JY, Kim HY, Lim KY, Han JH, Lee YJ, Kwak MH, Kim HJ, Yun T, Kim HT, Lee JS. A phase II study of sunitinib in patients with relapsed or refractory small cell lung cancer. Lung Cancer. 2013 Feb;79(2):137-42. doi: 10.1016/j.lungcan.2012.09.019. Epub 2012 Nov 20.
PubMed 23182663
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of First-line Treatment of Small Cell Lung Cancer (SCLC) With Anlotinib Hydrochloride in in Combination With EC/EP
- ClinicalTrials.gov ID
- NCT03890055
- Acronym / sponsor ID
- B19267BT
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chifeng Municipal HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 26 Mar 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.
This study was designed to investigate the efficacy and side effects of combining erlotinib with classical EC/EP chemotherapy regimens.
Detailed description
Lung cancer is a common malignant tumor that poses a serious threat to human health. Small cell lung cancer accounts for about 20% of lung cancer. Precision medicine has recently been perfectly interpreted in many tumor types, but the treatment of small cell lung cancer is still bleak. The EC/EP regimen is the most classic chemotherapy regimen for small cell lung cancer with good results but is prone to drug resistance. In 2018, with the development of immunotargeting therapy, small molecule multi-target anti-angi drugs, PARP inhibitors, new chemotherapy drugs, etc., the treatment of small cell lung cancer has ushered in a new dawn. As a kind of highly selective multi-target anti-angiogenic TKI drugs,Anlotinib Hydrochloride is a kind of 1.1 innovative drugs with independent intellectual property rights in China, mainly acting on VEGFR, PDGFR, FGFR and c-Kit. The latest ALTER1202 study confirms that anlotinib is significantly improved for PSC and ORR in SCLC patients who have previously received at least 2-line chemotherapy. OS data is not yet mature, but the benefits of the anlotinib group were observed. The adverse effects of anlotinib were consistent with expectations, no new adverse events were found, and safety was tolerated. Nowadays, the effective combination of traditional chemical therapy with molecular targeting and immunotherapy is the future development direction of lung cancer treatment. Therefore, this topic is designed to combine the efficacy of safety and safety with the treatment of anlotinib with the classic EC/EP chemotherapy regimen. Expected to get longer PFS and OS for patient benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical trial group | Experimental | Drug: Anlotinib Hydrochloride（Carboplatin/cisplatin + etoposide）+ （Anlotinib Hydrochloride 12 mg/day ，Each cycle was defined as 2 weeks on-treatment fol- lowed by 1 week off-treatment）, after 4-6 cycles of treatment, the treatment was continued with anlotinib until disease progression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients 18-75 years of age.
- A metastatic or recurrent advanced SCLC confirmed by histology or cytology and did not receive any other treatment;
- a measurable disease
- an Eastern Cooperative Oncology Group PS of 0-1;
- an estimated survival duration of >6 months;
Key exclusion criteria (1 listed)
- Have used erlotinib or other anti-vascular targeted drugs (eg, Endo, bevacizumab, etc.)2. Patients who have been treated with chemotherapy or radiotherapy for previous tumors.3.Have appeared or merged with other tumors within 5 years.4.Patients with no measurable lesions; 5.any severe and uncontrolled disease.
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: FocusvBest supportive care | Drug | Clinical trial group |
Primary outcome
PFS
Time frame: nine months
progression-free survival
4 secondary outcomes
OS
Time frame: 12 months
ORR
Time frame: 12 months
DCR
Time frame: 12 months
safety assessed by Adverse reactions
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Results publication: PubMed 23182663Han JY, Kim HY, Lim KY, Han JH, Lee YJ, Kwak MH, Kim HJ, Yun T, Kim HT, Lee JS. A phase II study of sunitinib in patients with relapsed or refractory small cell lung cancer. Lung Cancer. 2013 Feb;79(2):137-42. doi: 10.1016/j.lungcan.2012.09.019. Epub 2012 Nov 20.
- National Institutes of HeaithLink provided by the sponsor.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anlotinib Hydrochloride in people with Small Cell Lung Cancer, run by Chifeng Municipal Hospital.
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 5 inclusion and 1 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 26 Mar 2019. 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 Hongbo JI, postgraduate (18604868579, docjihongbo@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: nine 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 NCT03890055, which also lists 1 linked publication.
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 26 Mar 2019.