Combined Simvastatin and Albumin Paclitaxel in Treating ES-SCLC Patients Relapsed From 1st Chemotherapy

  • STATUS
    Recruiting
  • days left to enroll
    32
  • participants needed
    40
  • sponsor
    Shanghai Pulmonary Hospital, Shanghai, China
Updated on 8 August 2021
measurable disease
progressive disease
EGFR
cancer chemotherapy

Summary

This Phase II study was designed to evaluate the safety and efficacy of albumin paclitaxel in combination with simvastatin compared with treatment with albumin paclitaxel alone in ES-SCLC patients relapsed from first-line chemotherapy. Participants will be divided in a 1:1 ratio to receive either albumin paclitaxel (4 cycles) + simvastatin (10 months) or albumin paclitaxel (4 cycles) until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or symptomatic deterioration.

Description

PRIMARY OBJECTIVES:

I.To assess disease control rate (DCR) after treatment.

SECONDARY OBJECTIVES:

I.To assess best overall response rate (ORR) after treatment. II.To evaluate the progression-free survival (PFS) of patients with extensive stage-small cell lung cancer (ES-SCLC) treated with albumin paclitaxel + simvastatin or with albumin paclitaxel alone.

III.To estimate overall survival (OS) of patients with ES-SCLC. IV. To evaluate the toxicity profile of albumin paclitaxel + simvastatin.

EXPLORATORY OBJECTIVES:

I.To evaluate biomarkers correlatives. II.To explore the mechanism of albumin paclitaxel + simvastatin in the treatment of chemotherapy-resistant participants with ES-SCLC.

OUTLINE: Patients are divided into two arms. ARM A: Participants received intravenous infusions of albumin paclitaxel 260 milligrams per square meter (mg/m^2) on Day 1 of every 21-day cycle in combination with oral simvastatin (20mg daily) until persistent radiographic PD as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or symptomatic deterioration.

ARM B:Participants received intravenous infusions of albumin paclitaxel 260 mg/m^2 alone on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.

Details
Condition small cell carcinoma, small cell carcinoma of the lung, Small Cell Lung Cancer, sclc
Treatment Simvastatin, Albumin Paclitaxel
Clinical Study IdentifierNCT04698941
SponsorShanghai Pulmonary Hospital, Shanghai, China
Last Modified on8 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients must be volunteered to participate in the clinical trial. Patients must sign the informed Consent form (ICF) and be willing to follow and be able to complete all test procedures
Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system)
No patients with resectable or radical radiotherapy lung cancer
Patient must have no Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic lymphoma kinase (ALK) rearrangement, or ROS proto-oncogene 1 , receptor tyrosine kinase(ROS1) rearrangement
Patient must be at least resistant to the first-line chemotherapy
Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Patients can tolerate chemotherapy

Exclusion Criteria

Unclear diagnosis of SCLC
Resectable or radical radiotherapy SCLC
Contraindicated chemotherapy
Undergoing other active malignancies within 5 years or at the same time.Patients with localized curable tumors, such as basal cell carcinoma, squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ, will not be excluded
Positive test result for human immunodeficiency virus (HIV)
Positive test result for active tuberculosis
Live vaccine was administered within 28 days of initial administration. Inactivated viral vaccines for seasonal influenza are allowed, except for live attenuated intranasal vaccines
Pregnant or lactating women
A history of psychotropic substance abuse, drug abuse, or alcoholism
Other factors assessed by the sponsors
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