A Study of PLM60 in Subjects With Relapsed Small-cell Lun... | NCT04352413

Studies
A Study of PLM60 in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First-Line Chemotherapy

NCT04352413

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Status

Terminated

Last Update Posted

Mar 7, 2024Actual

Enrollment

45Actual

Phase

Phase 2

Conditions

Small Cell Lung Cancer

Interventions

PLM60

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The sponsor has adjusted its R&D strategy.

Expanded Access Info

Start Date

Jun 18, 2020Actual

Primary Completion Date

Jan 30, 2022Actual

Completion Date

Apr 29, 2022Actual

First Submitted Date

Apr 14, 2020

First Submission Date that Met QC Criteria

Apr 15, 2020

First Posted Date

Apr 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2024

Last Update Posted Date

Mar 7, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an open, multicenter phase II clinical study for PLM60. The primary aim of the study is to observe the initial efficacy of PLM60 in treatment of small cell lung cancer. The secondary aim is to explore the safety and PK characteristics of PLM60

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort A: PLM60	Experimental	20 mg/m2, 4 weeks/cycle, administered on day 1 of each cycle	Drug: PLM60
Cohort B: PLM60	Experimental	15mg/m2, 3 weeks/cycle, administered on day 1 of each cycle	Drug: PLM60

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PLM60	Drug	Administration: Intravenous infusion	Cohort A: PLM60 Cohort B: PLM60

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate (ORR)	To evaluate ORR in SCLC subjects treated with PLM60	Through study completion, an average of 2 year

Secondary Outcomes

Measure	Description	Time Frame
Duration of Response (DoR)	To evaluate DoR in SCLC subjects treated with PLM60	Through study completion, an average of 2 year
Disease Control Rate (DCR)	To evaluate DCR in SCLC subjects treated with PLM60

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of SCLC;
Must have recurrence or progression after platinum-based first-line chemotherapy or chemoradiation therapy for the treatment of SCLC;
ECOG performance status 0~2;
Measurable lesion according to RECIST v1.1;
Life expectancy ≥ 12 weeks;
Adequate organ function;
Signed informed consent from the patient.

Exclusion Criteria:

Radical surgical treatment for primary small cell lung cancer;
Any anti-tumor treatment received within 4 weeks before the first use of the study drug;
Untreated or symptomatic central nervous system (CNS) metastases;
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
History of serious systemic diseases;
History of serious autoimmune diseases;
Those receiving treatment of adriamycin or other anthracyclines previously, with the total cumulative adriamycin (or adriamycin-equivalent) dose of >360 mg/m2.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kun Lou	Department of Medicine, CSPC Clinical Development Division	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
West China Hospital of Sichuan University		Chengdu	Sichuan		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055752	Small Cell Lung Carcinoma

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided