SCLCPhase 2NCT05879068
A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC
A Phase 2 study testing PM8002 and Paclitaxel in people with SCLC, run by Biotheus Inc. at 11 sites in China.
Trial summary
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with paclitaxel as second line treatment for SCLC. 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 and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 11 sitesChina
- Study dates
- 27 May 2022to 30 Apr 2026
- 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 SCLC;
- Advanced SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors;
- 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
- History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
- Evidence and history of severe bleeding tendency;
- History of severe cardiovascular diseases within 6 months;
- Current presence of severe superior vena cava syndrome and spinal cord compression;
- Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
- History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
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- 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
11 sites in 1 country.
11 sites in 1 country
China11 sites
Peking University Cancer Hospital
Beijing
Jilin Provincial Tumor Hospital
Changchun
Hunan Cancer Hospital
Changsha
Sichuan Provincial People's Hospital
Chengdu
Zhejiang Provincial People's Hospital
Hangzhou
Harbin Medical University Cancer Hospital
Harbin
Shandong Cancer Hospital
Jinan
The First Affiliated Hospital of Nanchang University
Nanchang
Shanghai Pulmonary Hospital
Shanghai
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Henan Cancer Hospital
Zhengzhou
About this study
Official title: A Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Paclitaxel Injection as Second Line Treatment for Small Cell Lung Cancer(SCLC)
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with paclitaxel as second line treatment for SCLC.
Read the detailed description
This is a phase II, single arm study assessing the efficacy and safety of PM8002 in combination with paclitaxel as second line treatment for SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors therapy
- Conditions
- SCLC
- Being tested
- PM8002, Paclitaxel
- Keywords
- Second line
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM8002Drug
IV infusion
PaclitaxelDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| PM8002+Paclitaxel | Experimental | Subjects will be administered with PM8002 plus Paclitaxel via intravenously (IV) Q3W for 5 cycles, followed by PM8002 until disease progression or intolerable toxicity for a maximum of 2 years. Receives: Drug: PM8002; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective response rate (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
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
Secondary outcomes (4)
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
Progression free survival (PFS)
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
Overall survival (OS)
OS is the time from the date of first dosing date to death due to any cause.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start27 May 2022
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2026 (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
- 99 participants (estimated)
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
- NCT05879068
- Sponsor's protocol ID
- PM8002-B002C-SCLC-R
- Status last verified
- Dec 2024
- First submitted
- 17 May 2023
- Last updated
- 18 Dec 2024
- 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 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Paclitaxel Injection as Second Line Treatment for Small Cell Lung Cancer(SCLC)
- ClinicalTrials.gov ID
- NCT05879068
- Acronym / sponsor ID
- PM8002-B002C-SCLC-R
- Conditions
- SCLC
- Keywords
- Second line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Biotheus Inc.Industry (pharma, biotech, devices)
- Study start
- 27 May 2022 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 30 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 will evaluate the efficacy and safety of PM8002 in combination with paclitaxel as second line treatment for SCLC.
Detailed description
This is a phase II, single arm study assessing the efficacy and safety of PM8002 in combination with paclitaxel as second line treatment for SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PM8002+Paclitaxel | Experimental | Drug: PM8002, Drug: PaclitaxelSubjects will be administered with PM8002 plus Paclitaxel via intravenously (IV) Q3W for 5 cycles, followed by PM8002 until disease progression or intolerable toxicity 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 SCLC;
- Advanced SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors;
- Have adequate organ function;
Key exclusion criteria (10 listed)
- History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
- Evidence and history of severe bleeding tendency;
- History of severe cardiovascular diseases within 6 months;
- Current presence of severe superior vena cava syndrome and spinal cord compression;
- Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
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+Paclitaxel |
| PaclitaxelIV infusion | Drug | PM8002+Paclitaxel |
Primary outcome
Objective Response Rate
Time frame: Up to approximately 2 years
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Treatment related adverse events (TRAEs)
Time frame: Up to 30 days after last treatment
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
4 secondary outcomes
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of response (DoR)
Time frame: Up to approximately 2 years
Progression free survival (PFS)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
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 18 Dec 2024.
- 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
11 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 and Paclitaxel in people with SCLC, run by Biotheus Inc. at 11 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 10 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 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. 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 18 Dec 2024.