- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04740021
Study of LP002 in Combination With Chemotherapy for Patients With Extensive Stage Small Cell Lung Cancer
February 1, 2021 updated by: Taizhou HoudeAoke Biomedical Co., Ltd.
A Single-arm, Open-lable, Multicenter, Phase II Clinical Study of LP002 in Combination With Chemotherapy for Patients With Extensive Stage Small Cell Lung Cancer
LP002 is a highly selected recombinant humanized anti-PD-L1 monoclonal antibody.
This is a single-arm, multicenter study to evaluate the efficacy and safety of LP002 in combination with chemotherapy in patients with extensive stage samll cell lung cancer.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
46
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jialei Wang
- Phone Number: 021-64175590
- Email: wangjialeigcp@126.com
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China, 450000
- Recruiting
- Henan cancer hospital
-
Contact:
- Huijuan Wu
-
-
Hunan
-
Changsha, Hunan, China, 410006
- Not yet recruiting
- Hunan Cancer Hospital
-
-
Jiangsu
-
Wuxi, Jiangsu, China, 214122
- Recruiting
- Affiliated Hospital of Jiangnan University
-
Contact:
- Xiaosheng Hang
-
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Liaoning
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Jinzhou, Liaoning, China, 121000
- Recruiting
- The First Affiliated Hospital of Jinzhou Medical University
-
Contact:
- Zhitu Zhu
-
-
Shandong
-
Jinan, Shandong, China, 250000
- Recruiting
- Shandong Cancer Hospital
-
Contact:
- Zhifang Liu
-
-
Shanghai
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Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan University Shanghai Cancer Center
-
Contact:
- Jialei WANG
-
-
Xinjiang
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Urumqi, Xinjiang, China, 830011
- Recruiting
- Xinjiang Medical University Cancer Center
-
Contact:
- Zhigang Han
-
-
Yunnan
-
Kunming, Yunnan, China, 650000
- Recruiting
- Yunnan Cancer Hospital
-
Contact:
- Runxiang Liang
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be willing and able to provide written informed consent for the trial;
- Age ≥ 18 and ≤ 79 years old, male or female;
- Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
- No prior systemic therapy for ES-SCLC.
- Patients who have received prior chemoradiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle from diagnosis of extensive-stage SCLC.
- Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Has a life expectancy of ≥3 months.
- Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Has adequate organ function.
- Female participants of childbearing potential should have a negative pregnancy within 72 hours before the first dose of trial treatment. Male and female participants should agree to use an adequate method of contraception during the experiment and 24 weeks after the last administration of the test drugs.
Exclusion Criteria:
- Histologically or cytologically confirmed mixed SCLC.
- Suffered from other malignant tumors in the past 5 years (except skin basal cell carcinoma, squamous cell carcinoma, and cervical carcinoma in situ that have been effectively controlled).
- Prior to the first administration of the study drug, there was a grade > 1 toxicity (excluding hair loss) caused by previous anti-tumor treatments.
- Has received prior therapy with an anti-PD-1, or anti-PD-L1, or anti-CTLA-4 agents.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Uncontrolled or symptomatic hypercalcemia.
- Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≤ 1 week prior to the first dose of trial treatment.
- Has active autoimmune disease that has required systemic treatment in past 2 years.
- Has received a major surgery within 4 weeks prior to the first dose of trial treatment.
- Has received system treatment with corticosteroids (dose >10mg/day prednison or other therapeutic hormones) within 2 weeks prior to the first dose of trial treatment.
- Previous or present interstitial lung disease or non-communicable pneumonia, except for radiation pneumonia.
- Has uncontrolled systemic disease, such as diabetes or hypertension.
- Has a history of testing positive for human immunodeficiency virus (HIV), or known acquired immunodeficiency syndrome (AIDS), or stem cell transplantation or organ transplantation.
- Has untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 500 IU/ mL or active hepatitis C virus (HCV). Subjects with non-active HBsAg carriers, treated and stable hepatitis B (HBV DNA < 10^3 copies/ml or <500 IU/ mL) , and cured hepatitis C can be enrolled. Subjects with positive HCV antibodies are eligible only if the HCV RNA test results are negative.
- Has serious infections within 4 weeks or active infections requiring systemic treatment within 2 weeks prior to the first dose of trial treatment.
- Has a history of severe allergic reaction to any other monoclonal antibodies.
- Has participated in other anticancer drug clinical trials within 4 weeks.
- Is pregnant or breastfeeding.
- Has received a live vaccine within 30 days prior to the first dose of trial treatment.
- According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Experimental: LP002+EP
Participants recieve LP002 10 mg/kg intravenous (IV) on day 1 PLUS carboplatin titrated to an area under the plasma drug concentration-time curve [AUC] 5 IV on day 1 PLUS etoposide 100 mg/m^2 IV on days 1, 2 and 3 of each 21-day cycle
|
10 mg/kg administered as IV infusion on Day 1 of each 21-day cycle.
AUC 5 administered as IV infusion on Day 1 of each 21-day cycle.
100 mg/m^2 administered as IV infusion on Day 1, 2 and 3 of each 21-day cycle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS)
Time Frame: Up to approximately 15 months
|
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 assessed by investigators or death due to any cause, whichever occurs first.
|
Up to approximately 15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Control Rate (DCR)
Time Frame: up to approximately 15 months
|
DCR was defined as the percentage of participants who have a CR or a PR or a stable disease (SD), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.
|
up to approximately 15 months
|
Duration of Response (DOR)
Time Frame: up to approximately 15 months
|
DOR was defined as the time from the first documented evidence of a response of CR or PR, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.
|
up to approximately 15 months
|
Objective Response Rate (ORR)
Time Frame: up to approximately 15 months
|
ORR was defined as the percentage of participants who have a complete response (CR) or a partial response (PR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.
|
up to approximately 15 months
|
Number of Participants Who Experienced an Adverse Event (AE)
Time Frame: up to approximately 15 months
|
An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have had a causal relationship with this treatment.
|
up to approximately 15 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 2, 2020
Primary Completion (Anticipated)
February 1, 2022
Study Completion (Anticipated)
August 1, 2022
Study Registration Dates
First Submitted
February 1, 2021
First Submitted That Met QC Criteria
February 1, 2021
First Posted (Actual)
February 5, 2021
Study Record Updates
Last Update Posted (Actual)
February 5, 2021
Last Update Submitted That Met QC Criteria
February 1, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Carboplatin
- Etoposide
Other Study ID Numbers
- LP002-II-SCLC-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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