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TerminatedNCT04352413Updated Mar 7, 2024

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

A Phase 2 interventional study of PLM60 in Small Cell Lung Cancer, sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. Terminated at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-07.

Sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Phase 2, Interventional, and Treatment

Why this study was terminated
The sponsor has adjusted its R\&D strategy.
Phase
Phase 2
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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

02

Conditions studied

  • Small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 45 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd. is the lead sponsor of 161 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Radical surgical treatment for primary small cell lung cancer;
  2. Any anti-tumor treatment received within 4 weeks before the first use of the study drug;
  3. Untreated or symptomatic central nervous system (CNS) metastases;
  4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
  5. History of serious systemic diseases;
  6. History of serious autoimmune diseases;
  7. Those receiving treatment of adriamycin or other anthracyclines previously, with the total cumulative adriamycin (or adriamycin-equivalent) dose of >360 mg/m2.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Cohort A: PLM60

    20 mg/m2, 4 weeks/cycle, administered on day 1 of each cycle

    Drug: PLM60

  • Experimental
    Cohort B: PLM60

    15mg/m2, 3 weeks/cycle, administered on day 1 of each cycle

    Drug: PLM60

Interventions

  • DrugPLM60

    Administration: Intravenous infusion

06

What researchers measure

Primary outcomes

  1. Objective response rate (ORR)

    To evaluate ORR in SCLC subjects treated with PLM60

    Time frame: Through study completion, an average of 2 year

Secondary outcomes

  1. Duration of Response (DoR)

    To evaluate DoR in SCLC subjects treated with PLM60

    Time frame: Through study completion, an average of 2 year

  2. Disease Control Rate (DCR)

    To evaluate DCR in SCLC subjects treated with PLM60

    Time frame: Through study completion, an average of 2 year

  3. Progression Free Survival (PFS)

    To evaluate PFS in SCLC subjects treated with PLM60

    Time frame: Through study completion, an average of 2 year

  4. Overall Survival (OS)

    To evaluate OS in SCLC subjects treated with PLM60

    Time frame: Through study completion, an average of 2 year

  5. Adverse Events

    To evaluate the safety profiles in SCLC subjects treated with PLM60

    Time frame: Through study completion, an average of 2 year

  6. Serious Adverse Events (SAEs)

    To evaluate the safety profiles in SCLC subjects treated with PLM60

    Time frame: Through study completion, an average of 2 year

07

Study locations

1 site
  • West China Hospital of Sichuan University
    Chengdu, Sichuan, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04352413
Lead sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Responsible party
Sponsor
First posted
Apr 20, 2020
Start date
Jun 18, 2020
Primary completion
Jan 30, 2022
Completion
Apr 29, 2022
Last update
Mar 7, 2024

Study contacts

Kun Lou
study chair · Department of Medicine, CSPC Clinical Development Division

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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