A Phase II Study to Evaluate JMKX000197 Injection Versus Cisplatin in the Treatment of Malignant Pleural Effusion

June 14, 2026 updated by: Shanghai Jeyou Pharmaceutical Co., Ltd.

A Randomized, Controlled, Double-Blind, Multi-center Phase II Study to Evaluate JMKX000197 Injection Versus Cisplatin in the Treatment of Malignant Pleural Effusion

This study aims to evaluate the efficacy and safety of intrapleural JMKX000197 compared with intrapleural cisplatin in patients with malignant pleural effusion.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100017
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants with advanced solid tumors diagnosed by histopathology or cytopathology.
  • Moderate to large pleural effusions require intervention.
  • ECOG performance status: 0 to 2.
  • Life expectancy ≥ 3 months
  • Adequate organ function.
  • The serum pregnancy test of female participants of childbearing potential should be negative within 7 days prior to enrollment and must not be breastfeeding. With a fertile female/male must agree to use medically accepted non-pharmacological contraception during the study and for 6 months after the last dose.

Exclusion Criteria:

  • Bilateral pleural effusion or concurrent peritoneal effusion, or concurrent pericardial effusion.
  • Pleural effusion is either encapsulated or severely separated; Or merge with chylothorax; Or combined with infectious pleural effusion.
  • Known allergies to the study drug or its excipient components.
  • Have participated in other clinical trials within 28 days prior to randomization.
  • Major surgery within 28 days prior to randomization.
  • Central nervous system metastatic disease, leptomeningeal disease, or cord compression.
  • Clinical unstable or uncontrolled concomitant cardiovascular, pulmonary, hepatic, renal or seizures diseases.
  • Active infections that require systemic treatment.
  • Have a history of organ transplantation.
  • Any further condition which, in the opinion of the Investigator, the participant is not suitable in the present study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
JMKX000197
Drug: JMKX000197
Intrapleural administration
Experimental: Arm B
JMKX000197
Drug: JMKX000197
Intrapleural administration
Active Comparator: Arm C
Cisplatin
Drug: Cisplatin
Intrapleural administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Puncture/drainage - Free Survival (PuFS)
Time Frame: From the date of chest tube removal after the last dose of treatment until the date of next puncture /drainage or date of death from any cause, whichever come first, up to approximately 24 months
From the date of chest tube removal after the last dose of treatment until the date of next puncture /drainage or date of death from any cause, whichever come first, up to approximately 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Pleural effusion overall response (ORR)
Time Frame: Up to approximately 24 months
Up to approximately 24 months
AEs or SAEs
Time Frame: Up to approximately 29 days
Up to approximately 29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jeyou Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Jie Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 17, 2026

Primary Completion (Estimated)

January 12, 2028

Study Completion (Estimated)

August 14, 2028

Study Registration Dates

First Submitted

June 10, 2026

First Submitted That Met QC Criteria

June 14, 2026

First Posted (Actual)

June 16, 2026

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 14, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JMKX000197-MPE201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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