- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04055792
Sintilimab Combined With Anlotinib as Second or Further-line Therapy for ED-SCLC
Sintilimab Combined With Anlotinib as Second- or Further-line Therapy for Extensive Disease Small Cell Lung Cancer: A Prospective, Single-arm, Phase II Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In August 2018, the FDA approved Nivolumab as a third-line treatment for ED-SCLC patients. Sintilimab is another PD-1 inhibitor produced by China and has been approved by cFDA for lymphoma. Anlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) with effect of anti-tumor angiogenesis and tumor growth inhibition. The results of ALTER1202 showed that compared with placebo, Anlotinib single-agent as third-line treatment in ED-SCLC was effective, the median PFS was 4.1 versus 0.7 months, respectively (P < 0.001).
Immunotherapy combined with anti-angiogenic therapy has been proven effective and tolerable in non-small cell lung caner (NSCLC), while its efficacy and safety in SCLC has not been reported. Therefore, the investigators conduct this study to evaluate the efficacy and safety of Sintilimab combined with Anlotinib as second or further-line therapy for ED-SCLC patients.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Qiming Wang, PhD.
- Phone Number: +86-0371-65588421
- Email: qimingwang1006@126.com
Study Contact Backup
- Name: Huiling Li, Dr.
- Phone Number: +86-0371-65588251
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China, 450000
- Henan Cancer Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients must meet all of the following criteria to be enrolled:
- Histologically or cytologically confirmed ED-SCLC according to the VALG staging system, and not suitable for local treatment.
- Progressed after at least one line of platinum-containing chemotherapy.
- ≥1 measurable lesions based on Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1).
- Previous radiotherapy was allowed, but the radiotherapy area must be <25% of the bone marrow area (Cristy and Eckerman 1987) and no total pelvic or chest irradiation was used; the previous radiotherapy must have been completed for at least 4 weeks before the start of study drugs treatment, and the acute toxicity must have been restored; radiotherapy of local lesions cannot be included in measurable lesions unless significant progression is noted after radiotherapy.
- Prior surgery was allowed, provided that the treatment was completed at least 4 weeks before the start of study drugs treatment, and the acute toxicity must have been restored.
- ≥18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
- Life expectancy > 12 weeks.
- Adequate bone marrow, hepatic and renal function.
- Systolic blood pressure ≤160mmHg and diastolic pressure ≤90mmHg within 7 days before enrollment.
- Patients must sign study specific informed consent before registration.
- Female patients should be surgically sterilized, postmenopausal, or consent to use a medically approved contraceptive method (such as an IUD, contraceptive pill, or condom) during the study treatment period and for 6 months after the end of the study treatment period; Serum or urine pregnancy tests must be negative within 7 days prior to study enrollment and must be non-lactating; Male patients should be surgically sterilized or who have consented to use a medically approved form of contraception during the study treatment period and for 6 months after the end of the study treatment period.
Exclusion Criteria:
Any of the following conditions should not be included in this study:
- Patients with brain metastasis. Patients suspected of having brain metastases should be examined by brain CT or MRI before enrollment; Patients with a history of brain metastases must have completed treatment and no longer need corticosteroids; For asymptomatic patients, the investigator will determine whether to enroll.
- Patients with meningeal metastasis.
- Prior treatment with PD-1 inhibitor, PD-L1 inhibitor, CTLA4 inhibitor, or anti-angiogenic treatment.
- Accept any other anti-tumor treatment simultaneously.
- Diagnosed with active autoimmune diseases (congenital or acquired, patients with completely relieved or childhood vitiligo can be enrolled; patients with hypothyroidism and only need hormone replacement therapy can be rerolled; Patients with type 1 diabetes can also be enrolled).
- Diagnosed with interstitial pneumonia.
- Patients with hemorrhage tendency including acute hemorrhage of digestive tract, continuous hemorrhage disease or coagulation function disorder disease.
- Patients are using warfarin, heparin or aspirin (>325 mg/day) or NSAIDS to inhibit platelet function within 10 days prior to enrollment, or receiving dipyridamole, ticlopidine, clopidogrel or cilostazol treatment.
- Patients with accompanying diseases that seriously endanger the safety of the patient or affect the patient's completion of the study.
- Pregnant or lactating female.
- Prior other malignant diseases, except for cervical carcinoma in situ, papillary thyroid carcinoma, or non-melanoma skin cancer.
- Allergy to any component of the study drugs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sintilimab combine with Anlotinib
Sintilimab 200 mg on day 1 and oral daily Anlotinib 12 mg on days 1-14 once every 3 weeks
|
Sintilimab 200mg intravenously on day 1 and Anlotinib 12 mg on days 1-14 once every 3 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: 8 months
|
progression free survival
|
8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS
Time Frame: 24 months
|
overall survival
|
24 months
|
ORR
Time Frame: 8 months
|
objective response rate
|
8 months
|
DCR
Time Frame: 8 months
|
disease control rate
|
8 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Qiming Wang, 127 Dongming Road, Zhengzhou, 450008, People's Republic of China
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20200526
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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