Extensive-stage Small Cell Lung CancerPhase 2NCT03841136
Anlotinib Combined With Etoposide and Platinum in the Treatment of Lung Cancer
A Phase 2 study testing anlotinib in people with Extensive-stage Small Cell Lung Cancer, run by Fudan University at 1 site in China.
Trial summary
To evaluate the progression free survival of patients with extensive stage small cell lung cancer treated with anlotinib combined with EP/CE regimen 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 31 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
- Patients volunteered to participate in the study and have signed the informed consent.
- Histological or cytological diagnosis of extensive small cell lung cancer, and no indication of radical surgery or radiotherapy.
- There are measurable lesions defined by RECIST standard v1.1. A lesion can be considered measurable only if the previously irradiated lesion has clear progression after radiotherapy and the previous irradiated lesion is not the sole lesion.
- Initially treated patients who have not received any systematic therapy before. If have received postoperative adjuvant chemotherapy, the time to relapse is at least 6 months from the last adjuvant chemotherapy.
- 5）18~75 years old; ECOG PS score: 0~1 points; expected survival time is more than 3 months.
- 6）The main organs's function meets the following criteria within 14 days before treatment:
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- Routine blood test (without blood transfusion within 14 days): a) Hemoglobin (HB) ≥ 90 g / L; b) Absolute neutrophil (ANC) ≥ 1.5 × 109 / L; c) Platelets (PLT) ≥ 80×109/L
- Biochemical examination: a) Total bilirubin (TBIL) ≤ 1.5 times of the upper limit of the normal (ULN); b) Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5ULN.To patients with liver metastasis, ALT and AST ≤ 5ULN; c) Serum creatinine (Cr) ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min;
- Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ the lower limit of the normal (50%).
- 7）Patients with previously treated asymptomatic CNS metastases are allowed to participate in this study if all of the following criteria are met: a) No need for continuous corticosteroid therapy for CNS disease; b) No radiotherapy within 7 days prior to enrollment treatment; c) Imaging examination from the end of radiotherapy to screening period shows no CNS progression.
- 8）Women of childbearing age should agree to conduct contraception (such as intrauterine devices, contraceptives or condoms) during the study and within 6 months after the end of the study; and the serum or urine pregnancy test is negative within 7 days prior to study enrollment and they must be non-lactating patients; Men should agree to conduct contraception during the study and within 6 months after the end of the study.
Who cannot join
- Patients who have been treated with anlotinib capsules in the past.
- Patients who have previously received systemic chemotherapy, signal transduction inhibitors, targeted therapies, hormone and endocrine therapy.
- Patients with other malignant tumors occurred within 5 years prior to the enrollment, except those with cured cervical carcinoma in situ and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)] , basal or squamous cell skin cancer, and localized prostate cancer and ductal breast carcinoma in situ treated with radical surgery.
- Unresolved toxicity due to any previous treatment above CTC AE (4.0) level 2 or higher, excluding hair loss.
- Patients with a variety of factors affecting oral medications (such as dyspahgia, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.)
- Patients with symptomatic CNS metastases.
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- Patients with dysfucitonal coagulation (PT>16s, APTT>43s, TT>21s, Fbg<2g/L), and bleeding tendency (the following condition must be met within 14 days before the enrollment: the INR is within the normal range without using anticoagulants); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or the like; Patients with International Normalized Ratio (INR) of less than1.5 are allowed to use low-dose warfarin (1 mg orally, once daily) or aspirin (with a daily dose of no more than 100 mg) for prophylactic purposes.
- Patients with major surgical treatment, incisional biopsy or tremendous traumatic injury within 28 days prior to the enrollment.
- Patients with tumors that have invaded tissues surrounding vital blood vessels founded in imaging or with a high probability of fatal bleeding due to the invasion of tumors to vital blood vessels according to the judgements of the researchers during the follow-up study.
- Patients with uncontrolled pleural, pericardial, or peritoneal effusion requiring repeated drainage.
- Patients with any severe and/or uncontrolled disease, including:
- Patients with unsatisfactory blood pressure control (systolic blood pressure >150 mmHg, diastolic blood pressure >90 mmHg).
- Patients with myocardial ischemia or myocardial infarction of Grade I of higher level, arrhythmia (including QTC ≥ 440ms) and congestive heart failure above Grade 2 (New York Heart Association (NYHA) classification).
- Patients with active or uncontrolled severe infection (≥ CTC AE Level 2).
- Patients with a history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation.
- Patients with poor control of diabetes (fasting blood glucose (FBG)>10mmol/L).
- Patients with urine protein ≥ ++ indicated by routine urine test, and confirmed 24-hour urine protein quantitation > 1.0 g.
- Patients with seizures requiring treatment.
- Patients with bleeding tendency or medical history regardless of severity; Patients undergone bleeding events of a level ≥ CTCAE 3 within 4 weeks prior to the enrollment, and with unhealed wounds, ulcers or fractures.
- Patients undergone venous thrombosis events currently or within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism.
- Patients with a history of psychotropic drug abuse from which they are unable to abstain or with mental disorders.
- Patients who have participated in other clinical trials of anti-tumor drugs within four weeks.
- Patients with severe disease that threaten the safety of themselves or affect the completion of the study according to the investigators' judgment.
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, 200032
wang jia lei, PD
About this study
Official title: Phase II Clinical Trial of Anlotinib Combined With Etoposide and Platinum in the Treatment of Extensive Stage Small Cell Lung Cancer
To evaluate the progression free survival of patients with extensive stage small cell lung cancer treated with anlotinib combined with EP/CE regimen
Read the detailed description
To evaluate the progression free survival of patients with extensive stage small cell lung cancer treated with anlotinib combined with EP/CE regimen To evaluate the safety, tolerability, overall survival (OS), objective response rate (ORR), disease control rate (DCR), and quality of life (QoL) of patients with extensive stage small cell lung cancer treated with anlotinib
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Being tested
- anlotinib
- 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.
anlotinibDrug
Also called etoposide and platinum
anlotinib 12mg PO QD CBP(AUC 5mg/mL/min，or DDP（75mg/m2）D1 etoposide（100mg/m2）D1~D3
| Study group | Role | What they receive |
|---|---|---|
| anlotinib combined with EP | Experimental | anlotinib combined with etoposide and platinum Receives: Drug: anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
the progression free survival of patients with extensive stage small cell lung cancer treated with anlotinib combined with EP/CE regimen
Measured: from the first cycle of treatment (day one) to two month after the last cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Apr 2019 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion31 Dec 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.
- More trials run by Fudan 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jialei Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841136
- Sponsor's protocol ID
- ALTN-SCLC-001
- Status last verified
- Mar 2019
- First submitted
- 1 Feb 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Anlotinib Combined With Etoposide and Platinum in the Treatment of Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03841136
- Acronym / sponsor ID
- ALTN-SCLC-001
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 15 Feb 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.
To evaluate the progression free survival of patients with extensive stage small cell lung cancer treated with anlotinib combined with EP/CE regimen
Detailed description
To evaluate the progression free survival of patients with extensive stage small cell lung cancer treated with anlotinib combined with EP/CE regimen To evaluate the safety, tolerability, overall survival (OS), objective response rate (ORR), disease control rate (DCR), and quality of life (QoL) of patients with extensive stage small cell lung cancer treated with anlotinib
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anlotinib combined with EP | Experimental | Drug: anlotinibanlotinib combined with etoposide and platinum |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients volunteered to participate in the study and have signed the informed consent.
- Histological or cytological diagnosis of extensive small cell lung cancer, and no indication of radical surgery or radiotherapy.
- There are measurable lesions defined by RECIST standard v1.1. A lesion can be considered measurable only if the previously irradiated lesion has clear progression after radiotherapy and the previous irradiated lesion is not the sole lesion.
- Initially treated patients who have not received any systematic therapy before. If have received postoperative adjuvant chemotherapy, the time to relapse is at least 6 months from the last adjuvant chemotherapy.
- 5）18~75 years old; ECOG PS score: 0~1 points; expected survival time is more than 3 months.
Key exclusion criteria (24 listed)
- Patients who have been treated with anlotinib capsules in the past.
- Patients who have previously received systemic chemotherapy, signal transduction inhibitors, targeted therapies, hormone and endocrine therapy.
- Patients with other malignant tumors occurred within 5 years prior to the enrollment, except those with cured cervical carcinoma in situ and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)] , basal or squamous cell skin cancer, and localized prostate cancer and ductal breast carcinoma in situ treated with radical surgery.
- Unresolved toxicity due to any previous treatment above CTC AE (4.0) level 2 or higher, excluding hair loss.
- Patients with a variety of factors affecting oral medications (such as dyspahgia, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.)
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 |
|---|---|---|
| anlotinibAlso: etoposide and platinumanlotinib 12mg PO QD CBP(AUC 5mg/mL/min，or DDP（75mg/m2）D1 etoposide（100mg/m2）D1~D3 | Drug | anlotinib combined with EP |
Primary outcome
PFS
Time frame: from the first cycle of treatment (day one) to two month after the last cycle
the progression free survival of patients with extensive stage small cell lung cancer treated with anlotinib combined with EP/CE regimen
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
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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.
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 in people with Extensive-stage Small Cell Lung Cancer, run by Fudan 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 11 inclusion and 24 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 28 Mar 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 wang jia lei, doctor (18017312369, haitunqiao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: from the first cycle of treatment (day one) to two month after the last cycle). 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 28 Mar 2019.