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Efficacy and Safety of Anlotinib as Maintenance Treatment After First-line Chemotherapy in SCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03780283
Recruitment Status : Not yet recruiting
First Posted : December 19, 2018
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
First Hospital of Shijiazhuang City

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Carcinoma Lung Neoplasm Small Cell Lung Cancer Drug: Anlotinib Hydrochloride Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Anlotinib as Maintenance Treatment After First-line Chemotherapy in Small Cell Lung Cancer(SCLC):a Phase II Study
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anlotinib Hydrochloride
Participants receive Anlotinib 12mg, administered as PO on Day1-14 of each 21-day cycle until documented PD
Drug: Anlotinib Hydrochloride
Participants receive Anlotinib 12mg, administered as PO on Day1-14 of each 21-day cycle until documented PD or had unacceptable toxicity
Other Name: Anlotinib

No Intervention: placebo
observation



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 24 months ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780283


Contacts
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Contact: Yan Zhang, M.D. 17603119607 ext +86 13315978836@163.com

Locations
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China, Hebei
The First Hospital of Shijiazhuang
Shijiazhuang, Hebei, China, 050011
Contact: Yan Zhang    17603119607    13315978836@163.com   
Contact: Yanan Duan    15931106929    yanan2006@sohu.com   
Sponsors and Collaborators
First Hospital of Shijiazhuang City
Investigators
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Study Chair: Yan Zhang, M.D. The First Hospital of Shijiazhuang
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Responsible Party: First Hospital of Shijiazhuang City
ClinicalTrials.gov Identifier: NCT03780283    
Other Study ID Numbers: LC02
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by First Hospital of Shijiazhuang City:
SCLC
maintenance
Anlotinib
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms