Small-cell Lung CancerPhase 2NCT04740021
Study of LP002 in Combination With Chemotherapy for Patients With Extensive Stage Small Cell Lung Cancer
A Phase 2 study testing LP002, Carboplatin and Etoposide in people with Small-cell Lung Cancer, run by Taizhou HoudeAoke Biomedical Co., Ltd. at 8 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Small-cell Lung Cancer
- What is being tested?
- LP002, Carboplatin and Etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 8 sitesChina
- Study dates
- 2 Dec 2020to 1 Aug 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410006
Lin Wu
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250000
Zhifang Liu
- Recruiting
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121000
Zhitu Zhu
- Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650000
Runxiang Liang
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Jialei Wang
- Recruiting
Xinjiang Medical University Cancer Center
Ürümqi, Xinjiang, 830011
Zhigang Han
- Recruiting
Affiliated Hospital Of Jiangnan University
Wuxi, Jiangsu, 214122
Xiaosheng Hang
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Huijuan Wu
About this study
Official title: 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.
- Conditions
- Small-cell Lung Cancer
- Being tested
- LP002, Carboplatin, Etoposide
- 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.
LP002Drug
10 mg/kg administered as IV infusion on Day 1 of each 21-day cycle.
CarboplatinDrug
AUC 5 administered as IV infusion on Day 1 of each 21-day cycle.
EtoposideDrug
100 mg/m^2 administered as IV infusion on Day 1, 2 and 3 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: LP002+EP | Experimental | 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 Receives: Drug: LP002; Drug: Carboplatin; Drug: Etoposide |
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 the first documented disease progression per RECIST 1.1 assessed by investigators or death due to any cause, whichever occurs first.
Measured: Up to approximately 15 months
Secondary outcomes (4)
Objective Response Rate (ORR)
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.
Measured: up to approximately 15 months
Disease Control Rate (DCR)
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.
Measured: up to approximately 15 months
Duration of Response (DOR)
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.
Measured: up to approximately 15 months
Number of Participants Who Experienced an Adverse Event (AE)
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.
Measured: up to approximately 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start2 Dec 2020
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taizhou HoudeAoke Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740021
- Sponsor's protocol ID
- LP002-II-SCLC-01
- Status last verified
- Feb 2021
- First submitted
- 1 Feb 2021
- Last updated
- 5 Feb 2021
- 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 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04740021
- Acronym / sponsor ID
- LP002-II-SCLC-01
- Conditions
- Small-cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Taizhou HoudeAoke Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 5 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: LP002+EP | Experimental | Drug: LP002, Drug: Carboplatin, Drug: EtoposideParticipants 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 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
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 |
|---|---|---|
| LP00210 mg/kg administered as IV infusion on Day 1 of each 21-day cycle. | Drug | Experimental: LP002+EP |
| CarboplatinAUC 5 administered as IV infusion on Day 1 of each 21-day cycle. | Drug | Experimental: LP002+EP |
| Etoposide100 mg/m^2 administered as IV infusion on Day 1, 2 and 3 of each 21-day cycle. | Drug | Experimental: LP002+EP |
Primary outcome
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.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: up to approximately 15 months
Disease Control Rate (DCR)
Time frame: up to approximately 15 months
Duration of Response (DOR)
Time frame: up to approximately 15 months
Number of Participants Who Experienced an Adverse Event (AE)
Time frame: up to approximately 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LP002, Carboplatin and Etoposide in people with Small-cell Lung Cancer, run by Taizhou HoudeAoke Biomedical Co., Ltd. at 8 sites 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 21 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 5 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 8 sites 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 Jialei Wang (021-64175590, wangjialeigcp@126.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 approximately 15 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 5 Feb 2021.