Small Cell Lung CancerPhase 3NCT02875457
Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide/Cisplatin
A Phase 3 study testing apatinib;etoposide and cisplatin in people with Small Cell Lung Cancer, run by Third Military Medical University.
Trial summary
Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less toxic side effects and better patient tolerance. 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?
- apatinib;etoposide and cisplatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2023
- Phase
- Phase 3
- 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(SCLC), Extensive Stage.
- No prior cisplatin-based chemotherapy or radiotherapy.
- Males or females between 18 Years to 75 Years.
- Performance status of 0～2 on the ECOG criteria.
- Expected survival is above three months.
- 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).
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- 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).
- with brain metastases.
- The patients had accepted allogeneic organ transplantation.
- Bleeding tendency or coagulation disorders.
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- patients who need renal dialysis.
- 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 Study of Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide and Cisplatin Chemotherapy
Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less toxic side effects and better patient tolerance. However, the clinical application of apatinib in small cell lung cancer is still lack of evidence-based medicine. Etoposide and cisplatin chemotherapy is the first-line treatment for small-cell lung cancer. The purpose of this multicenter, randomized, prospective study is to investigate the efficacy and safety of apatinib as the maintenance therapy for extensive stage small cell lung cancer after combined with etoposide and cisplatin chemotherapy.
- Conditions
- Small Cell Lung Cancer
- Being tested
- apatinib;etoposide and cisplatin, placebo;etoposide and cisplatin
- Keywords
- small cell lung cancer; apatinib; etoposide; cisplatin
- 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.
apatinib;etoposide and cisplatinDrug
placebo;etoposide and cisplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, and apatinib 250mg/d , repeated every 21 days, a total of 6 cycles, and then continue to take apatinib 250mg/d until progressive Disease(PD). Receives: Drug: apatinib;etoposide and cisplatin |
| Arm B | Placebo comparator | Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, and placebo, repeated every 21 days, a total of 6 cycles, and then continue to take placebo until PD. Receives: Drug: placebo;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: 6 months
Secondary outcomes (4)
Overall survival
The first day of treatment to death or last survival confirm date.
Measured: 5 years
Tumor response rate
The ratio between the number of responders and number of patients assessable for tumor response.
Measured: 3 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 6 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 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2023 (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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 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
- Wang Dong, PH.D., Principal investigator, Daping Hospital, Third Military Medical University, Chongqing,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875457
- Sponsor's protocol ID
- AEP-ES-SCLC
- Status last verified
- Aug 2016
- First submitted
- 11 Jun 2016
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide and Cisplatin Chemotherapy
- ClinicalTrials.gov ID
- NCT02875457
- Acronym / sponsor ID
- AEP-ES-SCLC
- Conditions
- Small Cell Lung Cancer
- Keywords
- small cell lung cancer; apatinib; etoposide; cisplatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 23 Aug 2016 (estimated)
- 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.
Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less toxic side effects and better patient tolerance. However, the clinical application of apatinib in small cell lung cancer is still lack of evidence-based medicine. Etoposide and cisplatin chemotherapy is the first-line treatment for small-cell lung cancer. The purpose of this multicenter, randomized, prospective study is to investigate the efficacy and safety of apatinib 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 |
|---|---|---|
| Arm A | Experimental | Drug: apatinib;etoposide and cisplatinPatients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, and apatinib 250mg/d , repeated every 21 days, a total of 6 cycles, and then continue to take apatinib 250mg/d until progressive Disease(PD). |
| Arm B | Placebo comparator | Drug: placebo;etoposide and cisplatinPatients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, and placebo, repeated every 21 days, a total of 6 cycles, and then continue to take placebo until PD. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologic or cytologic diagnosis of small cell lung caner(SCLC), Extensive Stage.
- No prior cisplatin-based chemotherapy or radiotherapy.
- Males or females between 18 Years to 75 Years.
- Performance status of 0～2 on the ECOG criteria.
- Expected survival is above three months.
Key exclusion criteria (20 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).
- with brain metastases.
- The patients had accepted allogeneic organ transplantation.
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 |
|---|---|---|
| apatinib;etoposide and cisplatin | Drug | Arm A |
| placebo;etoposide and cisplatin | Drug | Arm B |
Primary outcome
Progression-free survival
Time frame: 6 months
The first day of treatment to the date that disease progression is reported.
4 secondary outcomes
Overall survival
Time frame: 5 years
Tumor response rate
Time frame: 3 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 6 months
Performance Status
Time frame: the first date of treatment to 30 days after the last dose of study drug, assessed up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
- 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.
Wang Dong, PH.D. principal investigator
Daping Hospital, Third Military Medical University, Chongqing,China
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing apatinib;etoposide and cisplatin in people with 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 9 inclusion and 20 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 24 Aug 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Wang Dong, 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: 6 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 24 Aug 2016.