SCLCPhase 2NCT05844150
A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC
A Phase 2 study testing PM8002, Platinum and Etoposide in people with SCLC, run by Biotheus Inc. at 17 sites in China.
Trial summary
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study to evaluate the efficacy and safety of PM8002 in combination with etoposide and platinum in first-line treatment of extensive-stage small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCLC
- What is being tested?
- PM8002, Platinum and Etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 17 sitesChina
- Study dates
- 1 Jun 2023to Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form before any trial-related processes;
- Age ≥18 years;
- Histologically or cytologically confirmed ES-SCLC;
- No prior systemic therapy for ES-SCLC;
- Have adequate organ function;
- The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
- Life expectancy of ≥12 weeks;
- Had at least one measurable tumor lesion according to RECIST v1.1.
Who cannot join
- Histologically or cytologically confirmed mixed SCLC;
- History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
- The toxicity of previous anti-tumor therapy has not been alleviated；
- Have received anti-platelet therapy within 10 days prior to the first dose of the study drugs;
- Evidence and history of severe bleeding tendency;
- History of severe cardiovascular diseases within 6 months;
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- Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
- History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
- History of alcohol abuse, psychotropic substance abuse or drug abuse;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
- Pregnant or lactating women;
- Other conditions considered unsuitable for this study by the investigator.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Beijing Cancer Hospital
Beijing
Jilin Cancer Hospital
Changchun
The First Affiliated Hospital of Chongqing Medical University
Chongqing
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Zhejiang Cancer Hospital
Hangzhou
Harbin Medical University Cancer Hospital
Harbin
Anhui Provincial Hospital
Hefei
Central Hospital Affiliated To Shandong First Medical University
Jinan
Hebei Petro China Central Hospital
Langfang
Linyi Cancer Hospital
Linyi
The First Affiliated Hospital of Nanchang University
Nanchang
The Affiliated Hospital of Qingdao University
Qingdao
Shandong Cancer Hospital
Shandong
Shanghai Pulmonary Hospital
Shanghai
Taizhou Hospital of Zhejiang Province
Taizhou
Tianjin Medical University General Hospital
Tianjin
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
About this study
Official title: A Phase II Clinical Trial to Evaluate the Efficacy and Safety of PM8002 in Combination With Etoposide and Platinum in First-line Treatment of Extensive-Stage Small Cell Lung Cancer
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study to evaluate the efficacy and safety of PM8002 in combination with etoposide and platinum in first-line treatment of extensive-stage small cell lung cancer
Read the detailed description
The study is divided into two parts.
The first part is single-arm study, 50 participants were enrolled as of 21 Nov 2023，and recruitment was completed.
The second part is randomized, double-blind study, active controlled design , which will be integrated to another global III study （NCT06712355）.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM8002Drug
IV infusion
PlatinumDrug
IV infusion
EtoposideDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| PM8002+Etoposide＋platinum | Experimental | Subjects will be administered with PM8002 plus Etoposide and platinum via intravenously (IV) Q3W for 4 cycles, followed by PM8002 until progression or for a maximum of 2 years. Receives: Drug: PM8002; Drug: Platinum; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Measured: Up to approximately 2 years
Secondary outcomes (8)
Overall survival (OS)
OS is the time from the date of randomization or first dosing date to death due to any cause.
Measured: Up to approximately 2 years
Progression free survival (PFS)
Progression free survival (PFS) is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).
Measured: Up to approximately 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or stable disease (SD) based on RECIST v1.1.
Measured: Up to approximately 2 years
Duration of response (DOR)
DOR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.
Measured: Up to approximately 2 years
Time to response (TTR)
TTR is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieve CR or PR (based on RECIST v1.1).
Measured: Up to approximately 2 years
Pharmacokinetic (PK) parameters
The PK parameters including serum concentrations of PM8002 at different time points after study drug administration.
Measured: Up to 30 days after last treatment
Anti-drug antibody (ADA)
To evaluate the incidence of ADA to PM8002.
Measured: Up to 30 days after last treatment
Treatment related adverse events (TRAEs)
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
Measured: Up to 30 days after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Jun 2023
- Primary completion10 May 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLCStudies of the same condition, open and under way.
- More trials run by Biotheus Inc.The sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotheus Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ying Cheng, Principal investigator, Jilin Provincial Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844150
- Sponsor's protocol ID
- PM8002-BC011C-SCLC-R
- Status last verified
- Mar 2025
- First submitted
- 25 Apr 2023
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be published or presented for publications (poster, abstract,articles or papers) or any presentations
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial to Evaluate the Efficacy and Safety of PM8002 in Combination With Etoposide and Platinum in First-line Treatment of Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05844150
- Acronym / sponsor ID
- PM8002-BC011C-SCLC-R
- Conditions
- SCLC
- Keywords
- ES-SCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Biotheus Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 May 2023 (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.
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study to evaluate the efficacy and safety of PM8002 in combination with etoposide and platinum in first-line treatment of extensive-stage small cell lung cancer
Detailed description
The study is divided into two parts.
The first part is single-arm study, 50 participants were enrolled as of 21 Nov 2023，and recruitment was completed.
The second part is randomized, double-blind study, active controlled design , which will be integrated to another global III study （NCT06712355）.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PM8002+Etoposide＋platinum | Experimental | Drug: PM8002, Drug: Platinum, Drug: EtoposideSubjects will be administered with PM8002 plus Etoposide and platinum via intravenously (IV) Q3W for 4 cycles, followed by PM8002 until progression or for a maximum of 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent form before any trial-related processes;
- Age ≥18 years;
- Histologically or cytologically confirmed ES-SCLC;
- No prior systemic therapy for ES-SCLC;
- Have adequate organ function;
Key exclusion criteria (12 listed)
- Histologically or cytologically confirmed mixed SCLC;
- History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
- The toxicity of previous anti-tumor therapy has not been alleviated；
- Have received anti-platelet therapy within 10 days prior to the first dose of the study drugs;
- Evidence and history of severe bleeding tendency;
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 |
|---|---|---|
| PM8002IV infusion | Drug | PM8002+Etoposide＋platinum |
| PlatinumIV infusion | Drug | PM8002+Etoposide＋platinum |
| EtoposideIV infusion | Drug | PM8002+Etoposide＋platinum |
Primary outcome
Objective response rate (ORR)
Time frame: Up to approximately 2 years
ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
8 secondary outcomes
Overall survival (OS)
Time frame: Up to approximately 2 years
Progression free survival (PFS)
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of response (DOR)
Time frame: Up to approximately 2 years
Time to response (TTR)
Time frame: Up to approximately 2 years
Pharmacokinetic (PK) parameters
Time frame: Up to 30 days after last treatment
Anti-drug antibody (ADA)
Time frame: Up to 30 days after last treatment
Treatment related adverse events (TRAEs)
Time frame: Up to 30 days after last treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: Yes. The data will be published or presented for publications (poster, abstract,articles or papers) or any presentations
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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.
Ying Cheng principal investigator
Jilin Provincial Tumor Hospital
17 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 PM8002, Platinum and Etoposide in people with SCLC, run by Biotheus Inc. at 17 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 8 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to approximately 2 years). 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 12 Mar 2025.