Relapsed Small Cell Lung CancerPhase 2NCT04757779
A Single-arm, Phase Ⅱ Clinical Trial of Anlotinib Hydrochloride Combined With Irinotecan or Docetaxel for Second Line Treatment of Nonsensitive Relapsed Small-cell Lung Cancer
A Phase 2 study testing anlotinib hydrochloride combined with irinotecan or docetaxel in people with Relapsed Small Cell Lung Cancer and Anlotinib, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
Anlotinib hydrochloride is a multi-target antiangiogenic drug. It was recommended by Chinese Society of Clinical Oncology(CSCO) guideline as a third-line treatment for advanced small-cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed Small Cell Lung Cancer, Anlotinib
- What is being tested?
- anlotinib hydrochloride combined with irinotecan or docetaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2019to 30 Dec 2024
- 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
- The subject volunteered to participate in the study with informed consent signed.
- Histologically or pathologically confirmed small-cell lung cancer (whether limited or advanced stage).
- Have received at least first-line platinum-based chemotherapy for small-cell lung cancer and comfirmed disease relapse with imaging material. Disease progression during previous chemotherapy or less than 6 month after last chemotherapy.
- Relapsed advanced small-cell lung cancer patients with symptom-controlled brain metastasis or leptomeningeal metastasis (subjects with symptomatic brain metastasis are allowed to receive radiotherapy, whether brain lesions can be deemed as target lesions is decided by investigators.); or patients with newly- discovered brain metastasis or leptomeningeal metastasis diagnosed by CT/MRI. Symptomatic or asymptomatic serosal cavity effusion (pleural effusion, ascites, pericardial effusion, local therapy is allowed). Radiotherapy for symptomatic bone metastasis or elsewhere is allowed as long as response evaluation is not affected.
- Age:18-75 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status(PS) score ≤ 2.
Show all 10Show fewer
- Survival is expected to be ≥ 6 months.
- At least one non-irradiated target lesion confirmed by CT/MRI scan less than 28 days before first dose of the study drug.
- Male and women must use contraception within first dose to 24 weeks after last dose.
- Major organ functions meet the following criteria within 7 days prior to treatment: blood routine examination and coagulation function (no blood transfusion within 14 days): hemoglobin≥90g/L; Absolute Neutrophil Count(ANC)≥1.5×109/L; Platelet (PLT)≥80×109/L; International normalized ratio(INR)≤1.5，Activated partial thromboplastin time(APTT)≤1.5 × upper limit of normal value(ULN); biochemical test standards: Total bilirubin(TBIL)≤1.5× ULN; ALT/AST≤2.5×ULN without liver metastasis, ALT/AST≤5×ULN with liver metastasis; Creatinine ≤1.25× ULN or endogenous creatinine clearance rate(Ccr)>45ml/min.
Who cannot join
- Non-small-cell lung cancer (including a mixture of small-cell and non-small cell lung cancer).
- Patients with small-cell lung cancer who relapsed more than 6 months after first- line treatment.
- Medical imaging shows that the distance between the tumor and large vessels is less than 5mm; or lesions invade major blood vessels; or patients who are at risk of severe bleeding during the following treatment which is determined by investigators.
- Medical imaging shows significant pulmonary cavity or necrotic tumor.
- Uncontrolled hypertension (systolic blood pressure≥140mmHg or diastolic blood pressure≥90mmHg, even with optimal medication treatment).
- Subjects with ≥grade Ⅱmyocardial ischemia or myocardial infarction, uncontrolled arrhythmia (include QT interval≥450ms for males, ≥470ms for females).
Show all 19Show fewer
- Heart function of NYHA grade Ⅲ-Ⅳ or left ventricle ejection fraction(LVEF)<50% confirmed by echocardiography.
- Coagulant function abnormality (INR>1.5 or PT>ULN+4 seconds or APTT> 1.5ULN), with a bleeding tendency or patients is receiving thrombolytic or anticoagulant therapy.
- For subjects who are using an anticoagulant or vitamin K antagonist (e.g. warfarin or heparin or other similar drugs), low dose heparin (6000-12000U daily for an adult) or aspirin (≤100mg daily) is allowed for preventive purposes when INR≤1.5.
- Symptoms or propensity to bleed within 3 months prior to screening (include gastrointestinal hemorrhage, ulcerative gastric bleeding, fecal occult blood 2+ or above, vasculitis).
- Arterial/venous thrombosis within 12 months prior to screening, e.g. cerebrovascular accident (include temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis, pulmonary embolism.
- Inherited or acquired bleeding and thrombus propensity (hemophilia, coagulation dysfunction, thrombocytopenia and hypersplenism).
- Unhealed wound or fracture for a long time.
- Major surgical operation or severe traumatic injury, bone fracture or ulcer within 4 weeks prior to screening, which affect drug absorption e.g. inability to swallow, chronic diarrhea and intestinal obstruction.
- Abdominal fistula, gastrointestinal perforation, intraperitoneal abscess within 6 months prior to screening; routine urine test indicate urine protein≥++ or 24- hours proteinuria≥1.0g.
- History of psychotropic drug abuse and cannot abstain from it or with mental disorders.
- Participation in other clinical trials of anti-tumor drugs within 4 weeks prior to screening.
- Previous or concurrent with other types of uncured malignancies, with the exception of cured basal cell carcinoma of the skin, carcinoma in situ of cervix and superficial bladder cancer.
- Pregnant or lactating women, fertile patients who are unwilling or unable to use effective contraceptives.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310002
Bing Xia, MD
About this study
Anlotinib hydrochloride is a multi-target antiangiogenic drug. It was recommended by Chinese Society of Clinical Oncology(CSCO) guideline as a third-line treatment for advanced small-cell lung cancer. This study intends to assess the efficacy and safety of anlotinib hydrochloride combined with irinotecan or docetaxel for second line treatment of nonsensitive relapsed small-cell lung cancer.
- Conditions
- Relapsed Small Cell Lung Cancer, Anlotinib
- Being tested
- anlotinib hydrochloride combined with irinotecan or docetaxel
- 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 combined with irinotecan or docetaxelDrug
From the start of the study, the subjects are orally administered with anlotinib 12mg on empty stomach.Subjects need to take anlotinib 2 weeks continuously and stop for 1 week(every 3 weeks is a cycle),the dose of anlotinib can be adjusted as 12mg,10mg or 8mg according to adverse effects.On Day1 and Day8, subjects are required to inject irinotecan (65mg/m2)or docetaxel (60mg/m2) of a cycle,until disease progression or intolerable toxicity, for 4 cycles at most.
| Study group | Role | What they receive |
|---|---|---|
| anlotinib hydrochloride combined with irinotecan or docetaxel | Experimental | From the start of the study, the subjects are orally administered with anlotinib 12mg on empty stomach. Subjects need to take anlotinib 2 weeks continuously and stop for 1 week(every 3 weeks is a cycle). On Day1 and Day8, subjects are required to inject irinotecan(65mg/m2) or docetaxel(60mg/m2) of a cycle,until disease progression or intolerable toxicity, for 4 cycles at most. Receives: Drug: anlotinib hydrochloride combined with irinotecan or docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate（ORR）
the proportion of patients assessed with complete response and partial response
Measured: 2 years
Secondary outcomes (5)
progression-free survival time（PFS）
the time from date of randomization to disease progression or death
Measured: 2 years
disease control rate（DCR）
the proportion of patients assessed with complete response，partial response and stable disease
Measured: 2 years
overall survival（OS）
the time from date of randomization to death from any cause
Measured: 2 years
quality of life（QoF）assessed by EORTC QLQ-C30
Quality of Life assessed by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30(EORTC QLQ-C30)
Measured: 2 years
quality of life（QoF）assessed by EORTC QLQ LC-13
Quality of Life assessed by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer (EORTC QLQ LC-13)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start30 Dec 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2024 (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 Relapsed 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
- Not applicable
- Intervention model
- Single group
- Model description
- From the start of the study, the subjects are orally administered with anlotinib 12mg on empty stomach. Subjects need to take anlotinib 2 weeks continuously and stop for 1 week(every 3 weeks is a cycle). On Day1 and Day8, subjects are required to inject irinotecan (65mg/m2) or docetaxel(60mg/m2) of a cycle,until disease progression or intolerable toxicity, for 4 cycles at most.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757779
- Sponsor's protocol ID
- HZCH-2019-004
- Status last verified
- Feb 2021
- First submitted
- 14 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang M, Tang Y, Liang J, Zhu L, Wang B, Pan K, Xu X, Chen X, Xia B. Combination of anlotinib and irinotecan as second-line therapy in extensive-stage small-cell lung cancer relapsed within six months: a single-arm phase Ⅱ study. Lung Cancer. 2025 Jul;205:108630. doi: 10.1016/j.lungcan.2025.108630. Epub 2025 Jun 20.
PubMed 40555062
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Phase Ⅱ Clinical Trial of Anlotinib Hydrochloride Combined With Irinotecan or Docetaxel for Second Line Treatment of Nonsensitive Relapsed Small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04757779
- Acronym / sponsor ID
- HZCH-2019-004
- Conditions
- Relapsed Small Cell Lung Cancer, Anlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 17 Feb 2021 (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 hydrochloride is a multi-target antiangiogenic drug. It was recommended by Chinese Society of Clinical Oncology(CSCO) guideline as a third-line treatment for advanced small-cell lung cancer. This study intends to assess the efficacy and safety of anlotinib hydrochloride combined with irinotecan or docetaxel for second line treatment of nonsensitive relapsed small-cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- From the start of the study, the subjects are orally administered with anlotinib 12mg on empty stomach. Subjects need to take anlotinib 2 weeks continuously and stop for 1 week(every 3 weeks is a cycle). On Day1 and Day8, subjects are required to inject irinotecan (65mg/m2) or docetaxel(60mg/m2) of a cycle,until disease progression or intolerable toxicity, for 4 cycles at most.
| Arm | Type | Receives |
|---|---|---|
| anlotinib hydrochloride combined with irinotecan or docetaxel | Experimental | Drug: anlotinib hydrochloride combined with irinotecan or docetaxelFrom the start of the study, the subjects are orally administered with anlotinib 12mg on empty stomach. Subjects need to take anlotinib 2 weeks continuously and stop for 1 week(every 3 weeks is a cycle). On Day1 and Day8, subjects are required to inject irinotecan(65mg/m2) or docetaxel(60mg/m2) of a cycle,until disease progression or intolerable toxicity, for 4 cycles at most. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The subject volunteered to participate in the study with informed consent signed.
- Histologically or pathologically confirmed small-cell lung cancer (whether limited or advanced stage).
- Have received at least first-line platinum-based chemotherapy for small-cell lung cancer and comfirmed disease relapse with imaging material. Disease progression during previous chemotherapy or less than 6 month after last chemotherapy.
- Relapsed advanced small-cell lung cancer patients with symptom-controlled brain metastasis or leptomeningeal metastasis (subjects with symptomatic brain metastasis are allowed to receive radiotherapy, whether brain lesions can be deemed as target lesions is decided by investigators.); or patients with newly- discovered brain metastasis or leptomeningeal metastasis diagnosed by CT/MRI. Symptomatic or asymptomatic serosal cavity effusion (pleural effusion, ascites, pericardial effusion, local therapy is allowed). Radiotherapy for symptomatic bone metastasis or elsewhere is allowed as long as response evaluation is not affected.
- Age:18-75 years old.
Key exclusion criteria (19 listed)
- Non-small-cell lung cancer (including a mixture of small-cell and non-small cell lung cancer).
- Patients with small-cell lung cancer who relapsed more than 6 months after first- line treatment.
- Medical imaging shows that the distance between the tumor and large vessels is less than 5mm; or lesions invade major blood vessels; or patients who are at risk of severe bleeding during the following treatment which is determined by investigators.
- Medical imaging shows significant pulmonary cavity or necrotic tumor.
- Uncontrolled hypertension (systolic blood pressure≥140mmHg or diastolic blood pressure≥90mmHg, even with optimal medication treatment).
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 combined with irinotecan or docetaxelFrom the start of the study, the subjects are orally administered with anlotinib 12mg on empty stomach.Subjects need to take anlotinib 2 weeks continuously and stop for 1 week(every 3 weeks is a cycle),the dose of anlotinib can be adjusted as 12mg,10mg or 8mg according to adverse effects.On Day1 and Day8, subjects are required to inject irinotecan (65mg/m2)or docetaxel (60mg/m2) of a cycle,until disease progression or intolerable toxicity, for 4 cycles at most. | Drug | anlotinib hydrochloride combined with irinotecan or docetaxel |
Primary outcome
objective response rate（ORR）
Time frame: 2 years
the proportion of patients assessed with complete response and partial response
5 secondary outcomes
progression-free survival time（PFS）
Time frame: 2 years
disease control rate（DCR）
Time frame: 2 years
overall survival（OS）
Time frame: 2 years
quality of life（QoF）assessed by EORTC QLQ-C30
Time frame: 2 years
quality of life（QoF）assessed by EORTC QLQ LC-13
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Derived from this study: PubMed 40555062Zhang M, Tang Y, Liang J, Zhu L, Wang B, Pan K, Xu X, Chen X, Xia B. Combination of anlotinib and irinotecan as second-line therapy in extensive-stage small-cell lung cancer relapsed within six months: a single-arm phase Ⅱ study. Lung Cancer. 2025 Jul;205:108630. doi: 10.1016/j.lungcan.2025.108630. Epub 2025 Jun 20.
- Individual participant dataSharing planned: No
Related trials for Relapsed Small Cell Lung Cancer
RecruitingPhase 1
Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease
Recurrent Small Cell Lung Cancer, Extensive-Stage Small Cell Lung Cancer
RecruitingEarly Phase 1
TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC
Small Cell Lung Cancer ( SCLC ), CAR-T Cell Therapy
Active, not recruitingPhase 2
Talazoparib and Low-Dose Temozolomide in Treating Participants With Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer
Recurrent Extensive Stage Small Cell Lung Carcinoma, Refractory Extensive Stage Small Cell Lung Carcinoma
RecruitingPhase 3
A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) [EMBOLD SCLC-301]
Neoplasms, Lung
RecruitingPhase 3
A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)
Small-cell Lung Cancer
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 hydrochloride combined with irinotecan or docetaxel in people with Relapsed Small Cell Lung Cancer and Anlotinib, run by First People's Hospital of Hangzhou 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 10 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 17 Feb 2021. 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 Bing Xia, MD (86 571 56006388, bxia_hzch@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate（ORR） (time frame: 2 years). 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 NCT04757779, 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 17 Feb 2021.