CarcinomaPhase 2NCT03780283
Efficacy and Safety of Anlotinib as Maintenance Treatment After First-line Chemotherapy in SCLC
A Phase 2 study testing Anlotinib Hydrochloride in people with Carcinoma and Lung Neoplasm, run by First Hospital of Shijiazhuang City at 1 site in China.
Trial summary
Investigations prospectively collected the SCLC patients who received current standard first-line treatment, the response was not progression disease(PD). and then participants receive Anlotinib 12mg, administered as PO on Day1-14 of each 21-day cycle until documented PD or had unacceptable toxicity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Lung Neoplasm, Small Cell Lung Cancer
- What is being tested?
- Anlotinib Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jan 2022
- 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
- 1. The subjects volunteered to participate in this study and signed the informed consent form, with good compliance and follow-up.
- 2. Male or female patients aged 18-75 years old. 3.After receiving the current standard first-line treatment, patients with small-cell Lung cancer who have received non-surgical treatment have reached stable disease(SD), (partial remission)PR and (complete remission)CR patients (a limit or extensive stage according to Veterans Administration Lung Study Group (VALG)).
- 4. Has a life expectancy of at least 3 months. 5. Has a performance status of 0 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- 6.Has adequate organ function. 7. Patients with asymptomatic or mild brain metastasis may be enrolled. 8. If female of childbearing potential, is willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents.
- 9. If male with a female partner(s) of child-bearing potential, must agree to use adequate contraception starting with the first dose of study medication through 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents.
Who cannot join
- 1.Non-small Cell Lung cancer 2. Imaging (CT or MRI) showed that the central tumor invaded the large blood vessels; or there is obvious pulmonary cavitation or necrotic tumor; 3.History and complications 3.1 Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.(patients with brain metastasis who have completed treatment 14 days before enrollment and have stable symptoms can be included in the group, but they need to be confirmed as having no symptoms of cerebral hemorrhage by brain MRI, CT).
- 3.2 Have Participated in other clinical studies or less than 4 weeks before the end of treatment in the previous clinical study.
- 3.3 Other active malignancies requiring concurrent treatment. 3.4 Known history of prior malignancy except if participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy, except for successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
- 3.5 Patients who have not recovered to level 1 or lower of The Common Terminology Criteria for Adverse Events 4.0 （NCI-CTCAE4.0）. After previous systemic anti-tumor treatment with anti-tumor treatment-related adverse reactions (except hair loss).
- 3.6 Abnormal coagulation function international normalized ratio(INR) >1.5 or prothrombin time(PT) > ULN+4 s or activated partial thromboplastin time (APTT) > 1.5ULN), with bleeding tendency or receiving thrombolytic or anticoagulant treatment.
- 3.7 Is expected to require any other form of antineoplastic therapy while on study.
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- 3.8 Received a live-virus vaccination within 30 days of planned start of study medication.
- 3.9 Known sensitivity to any component of Anlotinib. 3.10 Has active autoimmune disease that has required systemic treatment in past 2 years.
- 3.11 Is on chronic systemic steroids. 3.12 Has an active infection requiring therapy. 3.13 Has known history of Human Immunodeficiency Virus (HIV). 3.14 Has known active Hepatitis B or C. 3.15 Has known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.
- 3.16 Is a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).
- 3.17 Has symptomatic ascites or pleural effusion. 3.18 Has interstitial lung disease or a history of pneumonitis that required oral of IV glucocorticoids to assist with management.
- 3.19 Two or more combination therapies for hypertension that are still uncontrollable (systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg).
- 3.20 Arteriovenous thrombosis events occurred within 12 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism.
- 3.21 Clinically significant hemoptysis occurred within 3 months before enrollment (hemoptysis > 50ml daily);Or bleeding symptoms of significant clinical significance or with a clear bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, baseline stool occult blood ++ or above, or suffering from vasculitis.
- 3.22 Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction.
- 3.23 Is pregnant or breast feeding, or expecting to conceive or father children prior to 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Shijiazhuang
Shijiazhuang, Hebei, 050011
Yan Zhang, 17603119607, 13315978836@163.com
Yanan Duan, 15931106929, yanan2006@sohu.com
About this study
Official title: Efficacy and Safety of Anlotinib as Maintenance Treatment After First-line Chemotherapy in Small Cell Lung Cancer（SCLC）：a Phase II Study
Investigations prospectively collected the SCLC patients who received current standard first-line treatment, the response was not progression disease(PD). and then participants receive Anlotinib 12mg, administered as PO on Day1-14 of each 21-day cycle until documented PD or had unacceptable toxicity. This regimen is compared to the effects a observation without treatment after the first-line therapy. The aim of the study is therefore to evaluate the efficacy and safety of Anlotinib as maintenance treatment after first-line chemotherapy in SCLC patients.
- Conditions
- Carcinoma, Lung Neoplasm, Small Cell Lung Cancer
- Being tested
- Anlotinib Hydrochloride
- Keywords
- SCLC, maintenance, Anlotinib
- Medical subject headings
- Carcinoma, Lung Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib HydrochlorideDrug
Also called Anlotinib
Participants receive Anlotinib 12mg, administered as PO on Day1-14 of each 21-day cycle until documented PD or had unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib Hydrochloride | Experimental | Participants receive Anlotinib 12mg, administered as PO on Day1-14 of each 21-day cycle until documented PD Receives: Drug: Anlotinib Hydrochloride |
| placebo | No intervention | observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent central radiologists' (BICR) review. Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. (Note: the appearance of one or more new lesions was also considered progression). Participants were evaluated every 9 weeks with radiographic imaging to assess their response to treatment.
Measured: Up to 6 months
Secondary outcomes (1)
Objective Response Rate (ORR)
ORR was defined as the percentage of participants in the analysis population who experienced a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of Shijiazhuang City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Zhang, M.D., Study chair, The First Hospital of Shijiazhuang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780283
- Sponsor's protocol ID
- LC02
- Status last verified
- Dec 2018
- First submitted
- 17 Dec 2018
- Last updated
- 21 Dec 2018
- 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 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Anlotinib as Maintenance Treatment After First-line Chemotherapy in Small Cell Lung Cancer（SCLC）：a Phase II Study
- ClinicalTrials.gov ID
- NCT03780283
- Acronym / sponsor ID
- LC02
- Conditions
- Carcinoma, Lung Neoplasm, Small Cell Lung Cancer
- Keywords
- SCLC, maintenance, Anlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- First Hospital of Shijiazhuang CityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 19 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.
Investigations prospectively collected the SCLC patients who received current standard first-line treatment, the response was not progression disease(PD). and then participants receive Anlotinib 12mg, administered as PO on Day1-14 of each 21-day cycle until documented PD or had unacceptable toxicity. This regimen is compared to the effects a observation without treatment after the first-line therapy. The aim of the study is therefore to evaluate the efficacy and safety of Anlotinib as maintenance treatment after first-line chemotherapy in SCLC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib Hydrochloride | Experimental | Drug: Anlotinib HydrochlorideParticipants receive Anlotinib 12mg, administered as PO on Day1-14 of each 21-day cycle until documented PD |
| placebo | No intervention | –observation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. The subjects volunteered to participate in this study and signed the informed consent form, with good compliance and follow-up.
- 2. Male or female patients aged 18-75 years old. 3.After receiving the current standard first-line treatment, patients with small-cell Lung cancer who have received non-surgical treatment have reached stable disease(SD), (partial remission)PR and (complete remission)CR patients (a limit or extensive stage according to Veterans Administration Lung Study Group (VALG)).
- 4. Has a life expectancy of at least 3 months. 5. Has a performance status of 0 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- 6.Has adequate organ function. 7. Patients with asymptomatic or mild brain metastasis may be enrolled. 8. If female of childbearing potential, is willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents.
- 9. If male with a female partner(s) of child-bearing potential, must agree to use adequate contraception starting with the first dose of study medication through 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents.
Key exclusion criteria (16 listed)
- 1.Non-small Cell Lung cancer 2. Imaging (CT or MRI) showed that the central tumor invaded the large blood vessels; or there is obvious pulmonary cavitation or necrotic tumor; 3.History and complications 3.1 Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.(patients with brain metastasis who have completed treatment 14 days before enrollment and have stable symptoms can be included in the group, but they need to be confirmed as having no symptoms of cerebral hemorrhage by brain MRI, CT).
- 3.2 Have Participated in other clinical studies or less than 4 weeks before the end of treatment in the previous clinical study.
- 3.3 Other active malignancies requiring concurrent treatment. 3.4 Known history of prior malignancy except if participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy, except for successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
- 3.5 Patients who have not recovered to level 1 or lower of The Common Terminology Criteria for Adverse Events 4.0 （NCI-CTCAE4.0）. After previous systemic anti-tumor treatment with anti-tumor treatment-related adverse reactions (except hair loss).
- 3.6 Abnormal coagulation function international normalized ratio(INR) >1.5 or prothrombin time(PT) > ULN+4 s or activated partial thromboplastin time (APTT) > 1.5ULN), with bleeding tendency or receiving thrombolytic or anticoagulant 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 HydrochlorideAlso: AnlotinibParticipants receive Anlotinib 12mg, administered as PO on Day1-14 of each 21-day cycle until documented PD or had unacceptable toxicity | Drug | Anlotinib Hydrochloride |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Up to 6 months
PFS was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent central radiologists' (BICR) review. Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. (Note: the appearance of one or more new lesions was also considered progression). Participants were evaluated every 9 weeks with radiographic imaging to assess their response to treatment.
1 secondary outcome
Objective Response Rate (ORR)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 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.
Yan Zhang, M.D. study chair
The First Hospital of Shijiazhuang
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 in people with Carcinoma and Lung Neoplasm, run by First Hospital of Shijiazhuang City 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 5 inclusion and 16 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 21 Dec 2018. 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 Yan Zhang, M.D. (17603119607 ext. +86, 13315978836@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Up to 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 21 Dec 2018.