Extensive-stage Small-cell Lung CancerPhase 2NCT04675697
Anlotinib Plus Platinum-etoposide in First-line of Extensive-stage Small-cell Lung Cancer
A Phase 2 study testing Platinum-etoposide+Anlotinib in people with Extensive-stage Small-cell Lung Cancer, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Anlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) for tumor angiogenesis and tumor cell proliferation. The efficacy of Anlotinib as a third-line or beyond therapy for SCLC was confirmed in the ALTER1202 trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Extensive-stage Small-cell Lung Cancer
- What is being tested?
- Platinum-etoposide+Anlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 24 Jan 2019to 31 Jan 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Aged 18 to 70 years old;
- Rated as grade 0 to 2 in ECOG whole-body status (PS), or grade 3 to 4 if induced by SCLC;
- Of the expected survival no less than 3 months;
- With extensive-stage SLCL diagnosed pathologically (according to the VALG staging standard introduced by the Veterans Administration Lung Study Group), and having a measurable lesion (a tumor lesion of ≥ 10mm in long diameter in CT scanning, or a lymph node lesion of ≥ 15mm in short diameter in CT scanning, which had not received radiotherapy, cryotherapy or other local therapies, according to the RECIST1.1 standard);
- Having not received chemotherapy or immunotherapy;
- Some patients who have received radiotherapy can be included as long as the radiotherapy area in them is smaller than 25% of the bone marrow area, they haven't undergone total pelvic or chest radiation, their previous radiotherapy ended at least 4 weeks before the inclusion, they have recovered from radiotherapy-induced acute toxicity reaction, and the local lesion that underwent radiotherapy in them is not included in the measurable lesion, unless significant progress was observed in the lesion after the last radiotherapy.
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- Patients included should also have normal major organ functions, that is, their organs should meet the following criteria:
- Blood routine examination criteria: ANC ≥ 1.5 × 109/L, PLT ≥ 100 × 109/L and Hb≥100g/L (no blood transfusion or blood products in 14 days, and no G-CSF or other hematopoietic stimulant corrections).
- Biochemical examination criteria: TBIL < 1.5 × ULN, ALT, AST and ALP < 2.5 × ULN, BUN and Cr ≤ 1 × ULN, or endogenous creatinine clearance rate ≥ 50ml/min.
- Females of childbearing age should have taken reliable contraceptives or have had a negative pregnancy test (serum or urine) result 7 days before inclusion, and should be willing to take appropriate contraception measures during the study and in 8 weeks after the last administration of the treatment drug. Males should agree to take appropriate contraception measures during the study and in 8 weeks after the last administration of the treatment drug or have undergone sterilization operation.
- Subjects should voluntarily participate in the study, sign the Informed Consent, and be well compliant and cooperative in follow-up visits.
Who cannot join
- Having mixed small cell carcinoma and non-small cell carcinoma;
- Having active central nervous system (CNS) metastases and/or cancerous meningitis or found to have active central nervous system (CNS) metastases and/or cancerous meningitis in examinations during the screening stage. Patients can be included in the study as long as they: (1) Have asymptomatic brain metastases (without progressive central nervous system symptoms induced by brain metastases, requiring no corticosteroids, and having the lesion size ≤ 1.5cm), provided that they should undergo regular brain imaging examinations for the diseased site; (2) Have been treated and are in stable status, have no imaging evidence for new or enlarged brain metastases at least 2 weeks after brain metastasis treatment, and have discontinued steroids or anticonvulsants at least 14 days before the therapy of the study starts.
- Patients whose imaging findings showed invaded central great vessels or obvious pulmonary cavity or necrotizing tumor should be excluded.
- Patients with hypertension who are taking two or more antihypertensive drugs should be excluded.
- Patients having the following should be excluded: Cardiovascular diseases: Myocardial ischemia or myocardial infarction or grade II or above, uncontrolled arrhythmias, new functions of grade III to IV, or cardiac ejection fraction < 50%;
- Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds, or APTT > 1.5ULN), prone to bleeding or receiving thrombolytic or anticoagulant therapy;
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- Had significant cough blood or daily hemoptysis of 2.5ml or more in 2 months before the inclusion;
- Having bleeding symptoms or definite bleeding tendency of significant clinical significance, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ or above at baseline, or vasculitis, in 3 months before the inclusion;
- Having developed artery/venous thrombosis in 12 months before the inclusion;
- With known hereditary or acquired bleeding and thrombosis tendency;
- Having a wound or fracture that has cannot be healed for a long time;
- Having received major surgery or had severe traumatic injury, fracture or ulcer in 4 weeks before the inclusion;
- Subject to factors that significantly affect the absorption of oral medication;
- Having developed abdominal fistula, gastrointestinal perforation or abdominal abscess in 6 months before the inclusion;
- Having the urine routine result suggest urine protein ≥++, or confirmed the 24-hour urine protein amount ≥ 1.0g;
- With serous membrane effusion that is with clinical symptoms and requires symptomatic treatment;
- With active infections that require antimicrobial treatment;
- Having a history of psychotropic drug abuse and unable to quit or with a mental disorder;
- Having participated in other clinical trials on anti-tumor drugs 4 weeks before the inclusion;
- Previously or currently having other incurable malignancies;
- Having received over-potent CYP3A4 inhibitor treatment in 7 days before the inclusion, or have received over-potent CYP3A4 inducer treatment in 12 days before the inclusion.
- Pregnant or lactating women who are fertile but are unwilling or unable to take effective contraception measures should be excluded.
- Patients as determined by researchers to be subject to other conditions that may clinically affect the conduct or outcome of the study should be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital Central South University
Changsha, Hunan, 410000
Huaping Yang, M.D, +8613973129956, lyhuaping@aliyun.com
Pengbo Deng, M.D, +8613574888840, 12859155@qq.com
About this study
Official title: Anlotinib Plus Platinum-etoposide in First-line Treatment of Extensive-stage Small-cell Lung Cancer: a Single-arm Phase II Trial
Anlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) for tumor angiogenesis and tumor cell proliferation. The efficacy of Anlotinib as a third-line or beyond therapy for SCLC was confirmed in the ALTER1202 trial. The aim of this trial was to investigate the prognostic value of Anlotinib plus platinum-etoposide in first-line treatment of extensive-stage SCLC patients.
Read the detailed description
This single-arm phase II trial enrolled extensive-stage SCLC patients without prior systematic chemotherapy or immunity checkpoint inhibitors therapy at Xiangya hospital, Central South University from Aug 15, 2018 to Oct 7, 2020.The study was done in accordance with the International Conference on Harmonisation good clinical practice guidelines, the Declaration of Helsinki, and applicable local regulations with approval from an independent ethics committee or institutional review boards.
Eligible patients were age 18-70 years with histologically confirmed extensive-stage small-cell lung cancer as defined according to the staging standard introduced by the Veterans Administration Lung Study Group (VALG), measurable according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1), and an Eastern Cooperative Oncology Group (ECOG) performance-status (PS) score of 0 or 1, who had not received previous systemic treatment for extensive-stage small-cell lung cancer and were expected survival time ≥3 months. Patients with treated asymptomatic central nervous system (CNS) metastases were eligible under some circumstance (see the Supplementary Appendix). Key exclusion criteria were a history of mixed small cell carcinoma and non-small cell carcinoma and with active central nervous system (CNS) metastasis and/or cancerous meningitis during screenings.
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Being tested
- Platinum-etoposide+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.
Platinum-etoposide+AnlotinibDrug
Platinum-etoposide regiment consisted of etoposide 100mg/m2, d1~3 of 21-day cycle, with investigators' choice of either cisplatin (75-80mg/m2, Q3W) or carboplatin (AUC=5~6, Q3W). Anlotinib treated of 12mg Qd from day 1 to 14 of a 21-day cycle. Eligible patients received anlotinib plus platinum-etoposide for 4~6 cycles, and followed by maintenance therapy with Anlotinib. The efficacy was evaluated every 6 weeks (2 cycles) through treatment.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib+EP | Experimental | Not described Receives: Drug: Platinum-etoposide+Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: up to 1 year
ORR
objective response rate (ORR, CR+PR)
Measured: up to 1 year
Secondary outcomes (3)
OS
overall survival
Measured: From randomization until death (up to 15 months)
DCR
disease control rate (DCR, CR+PR+SD)
Measured: At the end of every 2 cycles (each cycle is 21 days)，through treatment，up to 1 year
DoR
duration of remission
Measured: At the end of every 2 cycles (each cycle is 21 days)，through treatment，up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start24 Jan 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jan 2021 (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 Extensive-stage Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Huaping S Yang, M.D, Study director, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675697
- Sponsor's protocol ID
- 2019010023
- Status last verified
- Dec 2020
- First submitted
- 2 Dec 2020
- Last updated
- 19 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Deng P, Hu C, Chen C, Cao L, Gu Q, An J, Qin L, Li M, He B, Jiang J, Yang H. Anlotinib plus platinum-etoposide as a first-line treatment for extensive-stage small cell lung cancer: A single-arm trial. Cancer Med. 2022 Oct;11(19):3563-3571. doi: 10.1002/cam4.4736. Epub 2022 May 8.
PubMed 35526266
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anlotinib Plus Platinum-etoposide in First-line Treatment of Extensive-stage Small-cell Lung Cancer: a Single-arm Phase II Trial
- ClinicalTrials.gov ID
- NCT04675697
- Acronym / sponsor ID
- 2019010023
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 19 Dec 2020 (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 is a novel multi-target tyrosine kinase inhibitor (TKI) for tumor angiogenesis and tumor cell proliferation. The efficacy of Anlotinib as a third-line or beyond therapy for SCLC was confirmed in the ALTER1202 trial. The aim of this trial was to investigate the prognostic value of Anlotinib plus platinum-etoposide in first-line treatment of extensive-stage SCLC patients.
Detailed description
This single-arm phase II trial enrolled extensive-stage SCLC patients without prior systematic chemotherapy or immunity checkpoint inhibitors therapy at Xiangya hospital, Central South University from Aug 15, 2018 to Oct 7, 2020.The study was done in accordance with the International Conference on Harmonisation good clinical practice guidelines, the Declaration of Helsinki, and applicable local regulations with approval from an independent ethics committee or institutional review boards.
Eligible patients were age 18-70 years with histologically confirmed extensive-stage small-cell lung cancer as defined according to the staging standard introduced by the Veterans Administration Lung Study Group (VALG), measurable according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1), and an Eastern Cooperative Oncology Group (ECOG) performance-status (PS) score of 0 or 1, who had not received previous systemic treatment for extensive-stage small-cell lung cancer and were expected survival time ≥3 months. Patients with treated asymptomatic central nervous system (CNS) metastases were eligible under some circumstance (see the Supplementary Appendix). Key exclusion criteria were a history of mixed small cell carcinoma and non-small cell carcinoma and with active central nervous system (CNS) metastasis and/or cancerous meningitis during screenings.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib+EP | Experimental | Drug: Platinum-etoposide+Anlotinib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1.Aged 18 to 70 years old;
- Rated as grade 0 to 2 in ECOG whole-body status (PS), or grade 3 to 4 if induced by SCLC;
- Of the expected survival no less than 3 months;
- With extensive-stage SLCL diagnosed pathologically (according to the VALG staging standard introduced by the Veterans Administration Lung Study Group), and having a measurable lesion (a tumor lesion of ≥ 10mm in long diameter in CT scanning, or a lymph node lesion of ≥ 15mm in short diameter in CT scanning, which had not received radiotherapy, cryotherapy or other local therapies, according to the RECIST1.1 standard);
- Having not received chemotherapy or immunotherapy;
Key exclusion criteria (23 listed)
- Having mixed small cell carcinoma and non-small cell carcinoma;
- Having active central nervous system (CNS) metastases and/or cancerous meningitis or found to have active central nervous system (CNS) metastases and/or cancerous meningitis in examinations during the screening stage. Patients can be included in the study as long as they: (1) Have asymptomatic brain metastases (without progressive central nervous system symptoms induced by brain metastases, requiring no corticosteroids, and having the lesion size ≤ 1.5cm), provided that they should undergo regular brain imaging examinations for the diseased site; (2) Have been treated and are in stable status, have no imaging evidence for new or enlarged brain metastases at least 2 weeks after brain metastasis treatment, and have discontinued steroids or anticonvulsants at least 14 days before the therapy of the study starts.
- Patients whose imaging findings showed invaded central great vessels or obvious pulmonary cavity or necrotizing tumor should be excluded.
- Patients with hypertension who are taking two or more antihypertensive drugs should be excluded.
- Patients having the following should be excluded: Cardiovascular diseases: Myocardial ischemia or myocardial infarction or grade II or above, uncontrolled arrhythmias, new functions of grade III to IV, or cardiac ejection fraction < 50%;
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 |
|---|---|---|
| Platinum-etoposide+AnlotinibPlatinum-etoposide regiment consisted of etoposide 100mg/m2, d1~3 of 21-day cycle, with investigators' choice of either cisplatin (75-80mg/m2, Q3W) or carboplatin (AUC=5~6, Q3W). Anlotinib treated of 12mg Qd from day 1 to 14 of a 21-day cycle. Eligible patients received anlotinib plus platinum-etoposide for 4~6 cycles, and followed by maintenance therapy with Anlotinib. The efficacy was evaluated every 6 weeks (2 cycles) through treatment. | Drug | Anlotinib+EP |
Primary outcome
PFS
Time frame: up to 1 year
progression-free survival
ORR
Time frame: up to 1 year
objective response rate (ORR, CR+PR)
3 secondary outcomes
OS
Time frame: From randomization until death (up to 15 months)
DCR
Time frame: At the end of every 2 cycles (each cycle is 21 days)，through treatment，up to 1 year
DoR
Time frame: At the end of every 2 cycles (each cycle is 21 days)，through treatment，up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Derived from this study: PubMed 35526266Deng P, Hu C, Chen C, Cao L, Gu Q, An J, Qin L, Li M, He B, Jiang J, Yang H. Anlotinib plus platinum-etoposide as a first-line treatment for extensive-stage small cell lung cancer: A single-arm trial. Cancer Med. 2022 Oct;11(19):3563-3571. doi: 10.1002/cam4.4736. Epub 2022 May 8.
- Individual participant dataSharing planned: Yes
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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.
Huaping S Yang, M.D study director
Xiangya Hospital of Central South 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 Platinum-etoposide+Anlotinib in people with Extensive-stage Small-cell Lung Cancer, run by Xiangya Hospital of Central South 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 23 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 19 Dec 2020. 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 Huaping S Yang, M.D (+8613973129956, lyhuaping@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: up to 1 year). The study lists 2 primary outcomes in all. 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 NCT04675697, 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 19 Dec 2020.