Extensive-stage Small Cell Lung CancerPhase 2NCT03781869
Study of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer
A Phase 2 study testing Anlotinib Hydrochloride; etoposide and cisplatin and etoposide and cisplatin in people with Extensive-stage Small Cell Lung Cancer, run by Third Military Medical University.
Trial summary
Anlotinib has been approved as a third-line treatment for advanced non-small-cell lung cancer. A phase II clinical studies of small cell lung cancer (ALTER-1210) also showed that, compared with placebo, Anlotinib could improve the patients survival and had less toxic side effects after 2-3 line therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extensive-stage Small Cell Lung Cancer
- What is being tested?
- Anlotinib Hydrochloride; etoposide and cisplatin and etoposide and cisplatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Dec 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
- Histologic or cytologic diagnosis of small cell lung caner
- Advanced small cell lung cancer who had no prior cisplatin-based chemotherapy or radiotherapy,at least one measurable lesion (by RECIST1.1)
- Males or females between 18 Years to 75 Years.
- Performance status of 0～2 on the ECOG criteria.
- Main organs function is normal
- Expected survival is above three months.
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- with asymptomatic brain metastases.
- At least one measurable lung tumor lesion (according to RECIST criteria, the application of conventional technology, diameter length of the lesion >= 20mm or spiral CT >=10mm).
- Adequate hematologic (Leukocyte count >= 4.0×109/L, neutrophil count>=2.0×109/L, hemoglobin>=95g/L, platelets>=100×109/L), hepatic function (aspartate transaminase (AST) \& alanine transaminase(ALT)
- =<upper normal limit(UNL) x1.5, bilirubin level =< UNL x 1.5).
- Patient can take oral medicine.
- Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up.
Who cannot join
- History of cardiovascular disease: congestive heart failure (CHF) > New York Heart Association (NYHA) II, active coronary artery disease(patients with myocardial infarction six months ago can be recruited), arrhythmias need to be treated (allow taking beta blockers or digoxin).
- Serious clinical infection (> NCI-CTCAE version 4.0 ,infection standard II).
- Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents).
- The patients had accepted allogeneic organ transplantation.
- Bleeding tendency or coagulation disorders.
- patients who need renal dialysis.
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- suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor).
- uncontrolled hypertension (systolic pressure>150 mmHg , or diastolic pressure> 90 mmHg).
- thrombosis or embolism(cerebrovascular accidents including transient ischemic attack within the last 6 months).
- pulmonary hemorrhage >CTCAE grade 2 within 4 weeks before first use of drugs.
- Other organ hemorrhage >CTCAE grade 3 within 4 weeks before first use of drugs.
- severe uncured wounds, ulcers or fracture.
- uncured dehydration.
- Drugs abuse and medical, psychological or social conditions may interfere with the patient's participation in research or the results of the evaluation effect.
- Patients are allergic to drugs used in research.
- Factors influencing the safety and compliance of patients.
- Inability to comply with protocol or study procedures.
- Pregnant or breast-feeding.
- The researcher believe that the Patient is not suitable to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer After Combined With Etoposide and Cisplatin Chemotherapy
Anlotinib has been approved as a third-line treatment for advanced non-small-cell lung cancer. A phase II clinical studies of small cell lung cancer (ALTER-1210) also showed that, compared with placebo, Anlotinib could improve the patients survival and had less toxic side effects after 2-3 line therapy. The purpose of this multicenter, randomized, prospective study is to investigate the efficacy and safety of Anlotinib as the maintenance therapy for Extensive-stage small cell lung cancer after combined with etoposide and cisplatin chemotherapy.
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Being tested
- Anlotinib Hydrochloride; etoposide and cisplatin, etoposide and cisplatin
- Keywords
- Small Cell Lung Cancer; 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 Hydrochloride; etoposide and cisplatinDrug
etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1 and Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle, repeated every 21 days
etoposide and cisplatinDrug
etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, repeated every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib + Chemotherapy | Experimental | Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 75mg/m2 on day 1, and Anlotinib 12mg/d on day 1 to day 14 , repeated every 21 days, a total of 4-6 cycles, and then continue to take Anlotinib 12mg/d on day 1 to day 14, repeated every 21 days until progressive Disease(PD). Receives: Drug: Anlotinib Hydrochloride; etoposide and cisplatin |
| Chemotherapy | Placebo comparator | Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 75mg/m2 on day 1, repeated every 21 days, a total of 4-6 cycles, and then follow up observation until PD. Receives: Drug: etoposide and cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The first day of treatment to the date that disease progression is reported
Measured: From randomization，each 42 days up to PD or death(up to 24 months
Secondary outcomes (5)
Overall survival
The first day of treatment to death or last survival confirm date
Measured: From randomization until death (up to 5 years)
Objective Response Rate
Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Treatment-related adverse events
Treatment-related adverse events are assessed by common terminology criteria for adverse events(CTCAE) V4.0.
Measured: the first date of treatment to 30 days after the last dose of study drug,assessed up to 24 months
Performance Status
Performance Status of patients will be assessed by Zubrod-Eastern cooperative oncology group(ECOG)-world health organization(WHO).
Measured: the first date of treatment to 30 days after the last dose of study drug, assessed up to 24 months
Disease Control Rate
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 posted20 Dec 2018
- Study startDec 2018 (estimated)
- Primary completionDec 2020 (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 Extensive-stage 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Wang, Third Military Medical University
- Investigators
- Dong Wang, PH.D, Principal investigator, Daping Hospital, Third Military Medical University, Chongqing,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781869
- Sponsor's protocol ID
- ALT-SCLC-01
- Status last verified
- Dec 2018
- First submitted
- 18 Dec 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer After Combined With Etoposide and Cisplatin Chemotherapy
- ClinicalTrials.gov ID
- NCT03781869
- Acronym / sponsor ID
- ALT-SCLC-01
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Keywords
- Small Cell Lung Cancer; Anlotinib; Maintenance therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 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 has been approved as a third-line treatment for advanced non-small-cell lung cancer. A phase II clinical studies of small cell lung cancer (ALTER-1210) also showed that, compared with placebo, Anlotinib could improve the patients survival and had less toxic side effects after 2-3 line therapy. The purpose of this multicenter, randomized, prospective study is to investigate the efficacy and safety of Anlotinib as the maintenance therapy for Extensive-stage small cell lung cancer after combined with etoposide and cisplatin chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib + Chemotherapy | Experimental | Drug: Anlotinib Hydrochloride; etoposide and cisplatinPatients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 75mg/m2 on day 1, and Anlotinib 12mg/d on day 1 to day 14 , repeated every 21 days, a total of 4-6 cycles, and then continue to take Anlotinib 12mg/d on day 1 to day 14, repeated every 21 days until progressive Disease(PD). |
| Chemotherapy | Placebo comparator | Drug: etoposide and cisplatinPatients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 75mg/m2 on day 1, repeated every 21 days, a total of 4-6 cycles, and then follow up observation until PD. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologic or cytologic diagnosis of small cell lung caner
- Advanced small cell lung cancer who had no prior cisplatin-based chemotherapy or radiotherapy,at least one measurable lesion (by RECIST1.1)
- Males or females between 18 Years to 75 Years.
- Performance status of 0～2 on the ECOG criteria.
- Main organs function is normal
Key exclusion criteria (19 listed)
- History of cardiovascular disease: congestive heart failure (CHF) > New York Heart Association (NYHA) II, active coronary artery disease(patients with myocardial infarction six months ago can be recruited), arrhythmias need to be treated (allow taking beta blockers or digoxin).
- Serious clinical infection (> NCI-CTCAE version 4.0 ,infection standard II).
- Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents).
- The patients had accepted allogeneic organ transplantation.
- Bleeding tendency or coagulation disorders.
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 Hydrochloride; etoposide and cisplatinetoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1 and Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle, repeated every 21 days | Drug | Anlotinib + Chemotherapy |
| etoposide and cisplatinetoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, repeated every 21 days | Drug | Chemotherapy |
Primary outcome
Progression-free survival
Time frame: From randomization，each 42 days up to PD or death(up to 24 months
The first day of treatment to the date that disease progression is reported
5 secondary outcomes
Overall survival
Time frame: From randomization until death (up to 5 years)
Objective Response Rate
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Treatment-related adverse events
Time frame: the first date of treatment to 30 days after the last dose of study drug,assessed up to 24 months
Performance Status
Time frame: the first date of treatment to 30 days after the last dose of study drug, assessed up to 24 months
Disease Control Rate
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 20 Dec 2018.
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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.
Dong Wang, PH.D principal investigator
Daping Hospital, Third Military Medical University, Chongqing,China
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib Hydrochloride; etoposide and cisplatin and etoposide and cisplatin in people with Extensive-stage Small Cell Lung Cancer, run by Third Military Medical 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 12 inclusion and 19 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 20 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. Some participants in this study may receive a placebo. 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 Dong Wang, PH.D. (86-23-68757151, dongwang64@hotmail.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 frame: From randomization，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 20 Dec 2018.