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SCLCPhase 3NCT06616532

PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer

A Phase 3 study testing PM8002, Paclitaxel and Topotecan in people with SCLC, run by Biotheus Inc. at 45 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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 to 75 years
Conditions the study is for
SCLC
What is being tested?
PM8002, Paclitaxel and Topotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
404 participants
Where
45 sitesChina
Study dates
13 Nov 2024to Dec 2028
Phase
Phase 3
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary participation in this clinical study; full understanding of the study and voluntary signing the informed consent form; willing to follow and abling to complete all trial procedures;
  • Age ≥18 years but ≤75 years;
  • Histologically or cytologically confirmed SCLC;
  • Advanced SCLC that has progressed or replased after first-line platinum-containing chemotherapy (extensive-stage patients must have received immune checkpoint inhibitors);
  • Having adequate organ functions;
  • The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
  • Life expectancy of 12 weeks or more;
  • Having 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;
  • Previous treatment with Paclitaxel or Topotecan or anti-vascular endothelial growth factor (VEGF) target drugs;
  • Current presence of severe superior vena cava syndrome and spinal cord compression;
  • Adverse events resulting from prior anti-tumor therapies should be assessed and graded according to the CTCAE 5.0 criteria, subjects whose AEs have not returned to Grade 1 or below;
  • Evidence of significant clotting disorder or other significant bleeding risk;
  • History of severe, uncontrollable, or active cardiovascular diseases within 6 months;
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  • Current presence of uncontrollable pleural, pericardial, and peritoneal effusions;
  • Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
  • History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
  • History of alcohol abuse, psychotropic substance abuse or drug abuse;
  • Pregnant or lactating women;
  • Other conditions considered unsuitable for this study by the investigator.

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

China45 sites

  • Binzhou Medical University Hospital

    Binzhou

  • Jilin Cancer Hospital

    Changchun

  • Hunan Cancer Hospital

    Changsha

  • Sichuan Cancer Hospital

    Chengdu

  • First People's Hospital of Chenzhou

    Chenzhou

  • The First Affiliated Hospital of Army Medical University

    Chongqing

  • The Second Hospital of Dalian Medical University

    Dalian

  • The First People's Hospital of Foshan

    Foshan

  • Fujian Cancer Hospital

    Fuzhou

  • The Affiliated Hospital Of Guilin Medical University

    Guilin

  • Zhejiang Cancer Hospital

    Hangzhou

  • Harbin Medical University Cancer Hospital

    Harbin

  • Anhui Province Hospital

    Hefei

  • Shandong Cancer Institute

    Jinan

  • Jingzhou First People's Hospital

    Jingzhou

  • Affiliated Hospital of Jining Medical University

    Jining

  • Yunnan Cancer Hospital

    Kunming

  • Liuzhou People's Hospital

    Liuzhou

  • The First Affiliated Hospital of Henan University of Science & Technology

    Luoyang

  • Meizhou People's Hospital

    Meizhou

  • Mianyang Central Hospital

    Mianyang

  • Jiangxi Cancer Hospital

    Nanchang

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • Nanchong Central Hospital

    Nanchong

  • Jiangsu Province Hospital

    Nanjing

  • Nanjing Drum-Tower Hospital

    Nanjing

  • Guangxi Medical University Cancer Hospital

    Nanning

  • Affiliated Hospital of Nantong University

    Nantong

  • Nanyang Central Hospital

    Nanyang

  • The First Affiliated Hospital Of Ningbo University

    Ningbo

  • Qujing NO.1 Hospital

    Qujing

  • The Fourth Hospital of Hebei Medical University

    Shijia Zhuang

  • Taizhou Enze Medical Center (group)

    Taizhou

  • Weifang NO.2 People's Hospital

    Weifang

  • Weihai Municipal Hospital

    Weihai

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan

  • Zhongnan Hospital Of Wuhan University

    Wuhan

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • Xiangyang Central Hospital

    Xiangyang

  • Xuzhou Central Hospital

    Xuzhou

  • The Second People's Hospital Of Yibin

    Yibin

  • Yongzhou Central Hospital

    Yongzhou

  • Yuncheng City Center Hospital

    Yuncheng

  • Zhangzhou Municipal Hospital of Fujian Province

    Zhangzhou

  • Zhoukou Central Hospital

    Zhoukou

Other trials in China

About this study

Official title: A Multicenter, Open-lable, Randomized Phase III Study of PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer

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 multicenter, randomized, open-label phase III study will evaluate the efficacy and safety of PM8002 in combination with Paclitaxel versus Investigator's Choice (Topotecan or Paclitaxel) as second-line treatment for subjects with SCLC.

Conditions
SCLC
Being tested
PM8002, Paclitaxel, Topotecan
Keywords
Second-line

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PM8002Drug

    Following a predefined dose and date.

  • PaclitaxelDrug

    175mg/m2 via IV infusion on Day 1 Q3W

  • TopotecanDrug

    1.25mg/m2/day via IV infusion on Days 1-5 Q3W

Study groups in NCT06616532
Study groupRoleWhat they receive
PM8002+PaclitaxelExperimentalSubjects will be administered with PM8002 in combination with Paclitaxel via intravenously (IV) infusion.
Receives: Drug: PM8002; Drug: Paclitaxel
ChemotherapyActive comparatorSubjects will be administered with Investigator's Choice(Topotecan or Paclitaxel) via intravenously (IV) infusion Q3W.
Receives: Drug: Paclitaxel; Drug: Topotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis are censored at the date of the last follow-up.

    Measured: Up to approximately 32 months from first patient in

Secondary outcomes (11)

  1. Progression-Free Survival (PFS) assessed by evaluated by investigator

    PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by investigator or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.

    Measured: Up to approximately 32 months from first patient in

  2. Objective response rate (ORR) evaluated by investigator

    ORR is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by investigators based on RECIST 1.1 is presented.

    Measured: Up to approximately 32 months from first patient in

  3. Disease control rate (DCR)

    DCR is defined as the sum rate of CR, PR and Stable Disease (SD), as determined by investigators based on RECIST v1.1

    Measured: Up to approximately 32 months from first patient in

  4. Time to response (TTR)

    Time to response(TTR) is defined as the time from randomization to the first documented PR or CR assssed by investigator based on RECIST v1.1

    Measured: Up to approximately 32 months from first patient in

  5. Duration of response (DOR)

    DoR is defined as the time period from the date of initial CR or PR until the date of PD or death due to any cause, whichever occurs first.

    Measured: Up to approximately 32 months from first patient in

  6. 6 month PFS rate

    PFS rate corresponding to the 6th month of the progression-free survival curve

    Measured: Up to approximately 32 months from first patient in

  7. 12 month PFS rate

    PFS rate corresponding to the 12th month of the progression-free survival curve

    Measured: Up to approximately 32 months from first patient in

  8. 12 month OS rate

    OS rate corresponding to the 12th month of the overall survival curve

    Measured: Up to approximately 32 months from first patient in

  9. Incidence and severity of Adverse Event (AE) according to CTCAE 5.0

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

    Measured: Up to 30 days after last treatment

  10. Anti-drug antibody (ADA)

    To evaluate the incidence and characteristics of ADA to PM8002

    Measured: Up to 30 days after last treatment

  11. Health related quality of life (HRQoL)

    Differences in the scores of health-related quality of life (HRQol)

    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.

  1. First posted27 Sep 2024
  2. Study start13 Nov 2024
  3. Primary completionMay 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
404 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06616532
Sponsor's protocol ID
PM8002-C014C-SCLC-R
Status last verified
Oct 2026
First submitted
23 Sep 2024
Last updated
22 Oct 2026
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PM8002, Paclitaxel and Topotecan in people with SCLC, run by Biotheus Inc. at 45 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Overall survival (OS) (time frame: Up to approximately 32 months from first patient in). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06616532.

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 22 Oct 2026.

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