Small Cell Lung CarcinomaPhase 2NCT03700359
A Study of Lobaplatin/Etoposide With or Without Anlotinib Maintenance Therapy in Patients With ES-SCLC
A Phase 2 study testing Anlotinib Hydrochloride, Lobaplatin and Etoposide in people with Small Cell Lung Carcinoma, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This is a prospective, randomized, open-label and active controlled phase II study. It plans to enroll 60 subjects with extensive stage small cell lung cancer (ES-SCLC). All subjects will be assigned randomly to the experimental arm or control arm. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Carcinoma
- What is being tested?
- Anlotinib Hydrochloride, Lobaplatin and Etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 29 Nov 2021
- Phase
- Phase 2
- 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
- Histopathologically confirmed patients with extensive small cell lung cancer;
- Karnofsky performance status ≥70;
- At least one lesion that can measured by CT;
- Expected to survive for at least 3 months;
- Peripheral blood and liver and kidney function within the following allowable range (tested within 7 days before treatment);
- White blood cell (WBC) ≥3.0×109/L or Neutrophils (ANC) ≥1.5×109/L;
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- Hemoglobin (HGB) ≥80 g/L；
- Platelet (PLT) ≥100×109/L;
- Liver transaminases（AST/ALT）<3.0 times the normal range limit;
- Total bilirubin（TBIL）<1.5 times the normal range limit;
- Creatinine（CREAT）<1.5 times the normal range limit;
- Patients of childbearing age (including female and male patients' partner) must take effective contraception methods;
- Signed informed consent;
- Known history of liver disease: Hepatitis B Virus (HBV) infection and Hepatitis B Virus DNA (HBV DNA ≥500 copies or ≥100 IU/ml); or Hepatitis C Virus (HCV) infection; or liver cirrhosis, etc.
- Human immunodeficiency virus (HIV);
- Subjects with difficulties in swallowing or known drug malabsorption; Those who meet each of the above criteria are included in the study.
Who cannot join
- Other pathological types of tumor except for small cell lung cancer;
- Patients with a history of severe allergies or allergies;
- Pregnancy or breastfeeding women;
- Patients who have previously participated in other clinical trials and have not yet terminated the trial;
- Combined with other tumors at the time of initial diagnosis;
- Patients who have previously participated in other clinical trials and have not yet terminated the trial;
- Patients who have acute infection that difficult to control;
- Drug abuse, substance abuse, chronic alcohol abuse, and AIDS patients. Those who meet any of the above criteria are not included in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Jiexia Zhang, prof., 13903056432, drzjxcn@126.com
About this study
Official title: A Randomized, Open-label Study of Lobaplatin/Etoposide as First Line Therapy With or Without Anlotinib Maintenance Therapy in Patients With Extensive-stage Small-cell Lung Cancer
This is a prospective, randomized, open-label and active controlled phase II study. It plans to enroll 60 subjects with extensive stage small cell lung cancer (ES-SCLC). All subjects will be assigned randomly to the experimental arm or control arm. The primary endpoints would be overall survival and progression-free survival.
Read the detailed description
Small cell lung cancer (SCLC) accounts for about 20% of lung cancer, has a high degree of malignancy, short doubling time, early and widespread metastasis, is sensitive to chemotherapy and radiotherapy, and has a high initial response rate, but is prone to secondary drug resistance and relapse. The treatment is mainly based on systemic chemotherapy.
SCLC has a more abundant vascular network than NSCLC. Anti-tumor vascular therapy combined with chemotherapy is considered the most promising SCLC first-line anti-tumor strategy. Anlotinib Hydrochloride has an anti-angiogenic effect and inhibits tumor's growth. It has been reported that Anlotinib has the dual benefits of both overall survival and progression-free survival in the treatment of multiple tumors, and has initially demonstrated its safety and efficacy. The ALTER 0303 study results showed that Anlotinib benefited both the overall and progression-free survival of NSCLC patients. However, there is no clinical study to probe its relevance to small cell lung cancer, and few studies have examined the status of Anlotinib in first-line treatment.
This randomized, open-label, controlled study is to evaluate the efficacy and safety of sequential EL regimen with Anlotinib hydrochloride as first-line treatment for extensive-stage SCLC. The study plan to enroll 60 ES-SCLC subjects and will provide evidence for the use of Anlotinib for SCLC first-line treatment.
- Conditions
- Small Cell Lung Carcinoma
- Being tested
- Anlotinib Hydrochloride, Lobaplatin, Etoposide
- Keywords
- extensive-stage small-cell lung cancer, lobaplatin/etoposide, Anlotinib maintenance therapy
- 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 AL3818
Anlotinib: Maintenance therapy 12mg/day P.O., day 1-15 every 21 days (2 weeks on, 1 week off) until progressive disease or treatment discontinuation
LobaplatinDrug
Also called D-19466
Lobaplatin:30 mg/m2 IV every 21 days for up to 4 cycles of 21 days
EtoposideDrug
Also called VP16
Etoposide: 60 mg/m2 IV every 21 days for up to 4 cycles of 21 days
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib/Lobaplatin/Etoposide | Experimental | EL regimen for 4 cycles followed by Anlotinib Hydrochloride maintenance therapy Receives: Drug: Anlotinib Hydrochloride; Drug: Lobaplatin; Drug: Etoposide |
| Lobaplatin/Etoposide | Active comparator | EL regimen for 4 cycles Receives: Drug: Lobaplatin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival Time
Progression free survival (PFS) is defined as the time from date of randomization to the date of objective disease progression or death due to any cause. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.
Measured: Time from randomization to first documented progression, assessed for up to 2 years
Secondary outcomes (2)
Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)
Overall Response Rate (ORR) is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions.
Measured: Up to 2 years
Overall Survival
Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.
Measured: Time from randomization to death by any cause, assessed for up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Mar 2019
- Primary completion29 Nov 2020 (estimated)
- Study completion29 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiexia Zhang, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Jiexia Zhang, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700359
- Sponsor's protocol ID
- ES-SCLC 001
- Status last verified
- Nov 2019
- First submitted
- 29 Jul 2018
- Last updated
- 29 Nov 2019
- 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 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study of Lobaplatin/Etoposide as First Line Therapy With or Without Anlotinib Maintenance Therapy in Patients With Extensive-stage Small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03700359
- Acronym / sponsor ID
- ES-SCLC 001
- Conditions
- Small Cell Lung Carcinoma
- Keywords
- extensive-stage small-cell lung cancer, lobaplatin/etoposide, Anlotinib maintenance therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 29 Nov 2020 (estimated)
- Study completion
- 29 Nov 2021 (estimated)
- First posted
- 9 Oct 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.
This is a prospective, randomized, open-label and active controlled phase II study. It plans to enroll 60 subjects with extensive stage small cell lung cancer (ES-SCLC). All subjects will be assigned randomly to the experimental arm or control arm. The primary endpoints would be overall survival and progression-free survival.
Detailed description
Small cell lung cancer (SCLC) accounts for about 20% of lung cancer, has a high degree of malignancy, short doubling time, early and widespread metastasis, is sensitive to chemotherapy and radiotherapy, and has a high initial response rate, but is prone to secondary drug resistance and relapse. The treatment is mainly based on systemic chemotherapy.
SCLC has a more abundant vascular network than NSCLC. Anti-tumor vascular therapy combined with chemotherapy is considered the most promising SCLC first-line anti-tumor strategy. Anlotinib Hydrochloride has an anti-angiogenic effect and inhibits tumor's growth. It has been reported that Anlotinib has the dual benefits of both overall survival and progression-free survival in the treatment of multiple tumors, and has initially demonstrated its safety and efficacy. The ALTER 0303 study results showed that Anlotinib benefited both the overall and progression-free survival of NSCLC patients. However, there is no clinical study to probe its relevance to small cell lung cancer, and few studies have examined the status of Anlotinib in first-line treatment.
This randomized, open-label, controlled study is to evaluate the efficacy and safety of sequential EL regimen with Anlotinib hydrochloride as first-line treatment for extensive-stage SCLC. The study plan to enroll 60 ES-SCLC subjects and will provide evidence for the use of Anlotinib for SCLC first-line treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib/Lobaplatin/Etoposide | Experimental | Drug: Anlotinib Hydrochloride, Drug: Lobaplatin, Drug: EtoposideEL regimen for 4 cycles followed by Anlotinib Hydrochloride maintenance therapy |
| Lobaplatin/Etoposide | Active comparator | Drug: Lobaplatin, Drug: EtoposideEL regimen for 4 cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histopathologically confirmed patients with extensive small cell lung cancer;
- Karnofsky performance status ≥70;
- At least one lesion that can measured by CT;
- Expected to survive for at least 3 months;
- Peripheral blood and liver and kidney function within the following allowable range (tested within 7 days before treatment);
Key exclusion criteria (8 listed)
- Other pathological types of tumor except for small cell lung cancer;
- Patients with a history of severe allergies or allergies;
- Pregnancy or breastfeeding women;
- Patients who have previously participated in other clinical trials and have not yet terminated the trial;
- Combined with other tumors at the time of initial diagnosis;
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: AL3818Anlotinib: Maintenance therapy 12mg/day P.O., day 1-15 every 21 days (2 weeks on, 1 week off) until progressive disease or treatment discontinuation | Drug | Anlotinib/Lobaplatin/Etoposide |
| LobaplatinAlso: D-19466Lobaplatin:30 mg/m2 IV every 21 days for up to 4 cycles of 21 days | Drug | Anlotinib/Lobaplatin/Etoposide, Lobaplatin/Etoposide |
| EtoposideAlso: VP16Etoposide: 60 mg/m2 IV every 21 days for up to 4 cycles of 21 days | Drug | Anlotinib/Lobaplatin/Etoposide, Lobaplatin/Etoposide |
Primary outcome
Progression Free Survival Time
Time frame: Time from randomization to first documented progression, assessed for up to 2 years
Progression free survival (PFS) is defined as the time from date of randomization to the date of objective disease progression or death due to any cause. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.
2 secondary outcomes
Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)
Time frame: Up to 2 years
Overall Survival
Time frame: Time from randomization to death by any cause, assessed for up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 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.
Jiexia Zhang principal investigator
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib Hydrochloride, Lobaplatin and Etoposide in people with Small Cell Lung Carcinoma, run by The First Affiliated Hospital of Guangzhou Medical 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 16 inclusion and 8 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 29 Nov 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jiexia Zhang, MD, PhD (86 20 83062830, drzjxcn@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival Time (time frame: Time from randomization to first documented progression, assessed for up to 2 years). 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 29 Nov 2019.