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New hope for tough lung cancer: Dual-Action drug combo in final testing

NCT ID NCT06616532

Disease control Sponsor: Biotheus Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests a new drug called PM8002, which targets the immune system and tumor blood vessels, combined with the chemotherapy paclitaxel. It is for people with small cell lung cancer whose disease has worsened after initial treatment. The study involves 404 participants and compares the new combo to standard chemotherapy. The main goal is to see if the combo helps people live longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PM8002 (a bispecific antibody targeting PD-L1 and VEGF) combined with paclitaxel
What this could lead to
If successful, this could offer a new second-line treatment option for small cell lung cancer, potentially improving survival.
What could go wrong
This is a phase 3 trial, but results are not yet available. The combination may not prove more effective than existing chemotherapy, and side effects from the drug combination are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 404 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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; 2. Age ≥18 years but ≤75 years; 3. Histologically or cytologically confirmed SCLC; 4. Advanced SCLC that has progressed or replased after first-line platinum-containing chemotherapy (extensive-stage patients must have received immune checkpoint inhibitors); 5. Having adequate organ functions; 6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1; 7. Life expectancy of 12 weeks or more; 8. Having at least one measurable tumor lesion according to RECIST v1.1; Exclusion Criteria: 1. History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs; 2. Previous treatment with Paclitaxel or Topotecan or anti-vascular endothelial growth factor (VEGF) target drugs; 3. Current presence of severe superior vena cava syndrome and spinal cord compression; 4. 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; 5. Evidence of significant clotting disorder or other significant bleeding risk; 6. History of severe, uncontrollable, or active cardiovascular diseases within 6 months; 7. Current presence of uncontrollable pleural, pericardial, and peritoneal effusions; 8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome; 9. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation; 10. History of alcohol abuse, psychotropic substance abuse or drug abuse; 11. Pregnant or lactating women; 12. Other conditions considered unsuitable for this study by the investigator.

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SCLC

Contacts and locations

Locations

  • Affiliated Hospital of Jining Medical University

    Jining, China

  • Affiliated Hospital of Nantong University

    Nantong, China

  • Anhui Province Hospital

    Hefei, China

  • Binzhou Medical University Hospital

    Binzhou, China

  • First People's Hospital of Chenzhou

    Chenzhou, China

  • Fujian Cancer Hospital

    Fuzhou, China

  • Guangxi Medical University Cancer Hospital

    Nanning, China

  • Harbin Medical University Cancer Hospital

    Harbin, China

  • Hunan Cancer Hospital

    Changsha, China

  • Jiangsu Province Hospital

    Nanjing, China

  • Jiangxi Cancer Hospital

    Nanchang, China

  • Jilin Cancer Hospital

    Changchun, China

  • Jingzhou First People's Hospital

    Jingzhou, China

  • Liuzhou People's Hospital

    Liuzhou, China

  • Meizhou People's Hospital

    Meizhou, China

  • Mianyang Central Hospital

    Mianyang, China

  • Nanchong Central Hospital

    Nanchong, China

  • Nanjing Drum-Tower Hospital

    Nanjing, China

  • Nanyang Central Hospital

    Nanyang, China

  • Qujing NO.1 Hospital

    Qujing, China

  • Shandong Cancer Institute

    Jinan, China

  • Sichuan Cancer Hospital

    Chengdu, China

  • Taizhou Enze Medical Center (group)

    Taizhou, China

  • The Affiliated Hospital Of Guilin Medical University

    Guilin, China

  • The First Affiliated Hospital Of Ningbo University

    Ningbo, China

  • The First Affiliated Hospital of Army Medical University

    Chongqing, China

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

    Luoyang, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, China

  • The First People's Hospital of Foshan

    Foshan, China

  • The Fourth Hospital of Hebei Medical University

    Shijia Zhuang, China

  • The Second Hospital of Dalian Medical University

    Dalian, China

  • The Second People's Hospital Of Yibin

    Yibin, China

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

    Wuhan, China

  • Weifang NO.2 People's Hospital

    Weifang, China

  • Weihai Municipal Hospital

    Weihai, China

  • Xiangyang Central Hospital

    Xiangyang, China

  • Xuzhou Central Hospital

    Xuzhou, China

  • Yongzhou Central Hospital

    Yongzhou, China

  • Yuncheng City Center Hospital

    Yuncheng, China

  • Yunnan Cancer Hospital

    Kunming, China

  • Zhangzhou Municipal Hospital of Fujian Province

    Zhangzhou, China

  • Zhejiang Cancer Hospital

    Hangzhou, China

  • Zhongnan Hospital Of Wuhan University

    Wuhan, China

  • Zhoukou Central Hospital

    Zhoukou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.