AzTrials
AzTrials

Small Cell Lung CancerPhase 2NCT04698941

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

A Phase 2 study testing Albumin Paclitaxel and Simvastatin in people with Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Albumin Paclitaxel and Simvastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesChina
Study dates
25 Jul 2021to 30 Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Hongbin Ji, PHD contact

+86-21-54921108

hbji@sibcb.ac.cn

China2 sites, 2 recruiting

  • CAS Center for Excellence in Molecular Cell Science, Shanghai Institute of Biochemistry and Cell Biology, Chinese Academy of Sciences

    Shanghai, Shanghai Municipality, 200031

    Hongbin Ji, PHD

    Recruiting

  • Shanghai pulmonary hospital, Tongji University

    Shanghai, Shanghai Municipality, 200433

    Yayi He, Doctor

    Recruiting

Other trials in China

About this study

Official title: Clinical Study of Albumin Paclitaxel With or Without Simvastatin in Treating Extensive-Stage Small Cell Lung Cancer Patients Relapsed From First-line Chemotherapy

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.

Read the detailed 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.

Being tested
Albumin Paclitaxel, Simvastatin
Keywords
ES-SCLC, Chemo-resistance, Simvastatin
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Albumin PaclitaxelDrug

    Albumin Paclitaxel intravenous infusion was administered at a dose of 260 mg/m^2 on Day 1 of each 21-day cycle.

  • SimvastatinDrug

    Also called Simvastatin Tablets

    20mg daily oral tablet taken.

Study groups in NCT04698941
Study groupRoleWhat they receive
Simvastatin + Albumin PaclitaxelExperimentalreceived intravenous infusions of Paclitaxel 260 milligrams per square meter (mg/m^2) on Day 1 of every 21-day cycle (4 cycles) in combination with oral simvastatin (20mg daily) (10 months)
Receives: Drug: Albumin Paclitaxel; Drug: Simvastatin
Albumin PaclitaxelActive comparatorreceived intravenous infusions of Paclitaxel 260 milligrams per square meter (mg/m^2) on Day 1 of every 21-day cycle (4 cycles)
Receives: Drug: Albumin Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease control rate (DCR)

    To assess disease control rate (DCR) after treatment.

    Measured: 6 weeks

Secondary outcomes (4)

  1. Overall response rate (ORR)

    To assess best overall response rate (ORR) after treatment.

    Measured: 6 weeks

  2. Progression-free survival (PFS)

    To evaluate the progression-free survival (PFS) of patients with extensive stage small cell lung cancer (ES-SCLC) treated with paclitaxel + simvastatin or with paclitaxel alone.

    Measured: 12 weeks

  3. Overall survival (OS)

    To estimate overall survival (OS) of patients with ES-SCLC.

    Measured: 24 weeks

  4. Number of participants with treatment-related adverse events (AE) as assessed by CTCAE v4.0

    To evaluate the toxicity profile.

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2021
  2. Study start25 Jul 2021
  3. Primary completion30 Dec 2021 (estimated)
  4. Study completion30 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04698941
Sponsor's protocol ID
2020LY021
Status last verified
Jul 2021
First submitted
30 Dec 2020
Last updated
29 Jul 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Goldman JW, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Ozguroglu M, Ji JH, Garassino MC, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Kazarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Thiyagarajah P, Jiang H, Paz-Ares L; CASPIAN investigators. Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2021 Jan;22(1):51-65. doi: 10.1016/S1470-2045(20)30539-8. Epub 2020 Dec 4.

    PubMed 33285097

  • Gelsomino F, Tiseo M, Barbieri F, Riccardi F, Cavanna L, Frassoldati A, Delmonte A, Longo L, Dazzi C, Cinieri S, Colantonio I, Sperandi F, Lamberti G, Brocchi S, Tofani L, Boni L, Ardizzoni A. Phase 2 study of NAB-paclitaxel in SensiTivE and refractory relapsed small cell lung cancer (SCLC) (NABSTER TRIAL). Br J Cancer. 2020 Jul;123(1):26-32. doi: 10.1038/s41416-020-0845-3. Epub 2020 Apr 29.

    PubMed 32346071

  • Chen Y, Li X, Zhang R, Xia Y, Shao Z, Mei Z. Effects of statin exposure and lung cancer survival: A meta-analysis of observational studies. Pharmacol Res. 2019 Mar;141:357-365. doi: 10.1016/j.phrs.2019.01.016. Epub 2019 Jan 11.

    PubMed 30641276

  • Khanzada UK, Pardo OE, Meier C, Downward J, Seckl MJ, Arcaro A. Potent inhibition of small-cell lung cancer cell growth by simvastatin reveals selective functions of Ras isoforms in growth factor signalling. Oncogene. 2006 Feb 9;25(6):877-87. doi: 10.1038/sj.onc.1209117.

    PubMed 16170339

  • Holstein SA, Hohl RJ. Synergistic interaction of lovastatin and paclitaxel in human cancer cells. Mol Cancer Ther. 2001 Dec;1(2):141-9.

    PubMed 12467231

  • Guan M, Zhao W, Zhang W, Chen X, Huang R, Liu X, Li Y, Wang H, Zhao L, Xu K, Ye L, Chen Z, Liu Y, Zhang Q, Ji H, He Y. Efficacy and safety of albumin-bound paclitaxel combined with simvastatin in the second-line treatment of small cell lung cancer: a phase II randomized controlled trial. BMC Med. 2026 Apr 6;24(1):383. doi: 10.1186/s12916-026-04835-7.

    PubMed 41937137

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Albumin Paclitaxel and Simvastatin in people with Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hongbin Ji, PHD (+86-21-54921108, hbji@sibcb.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease control rate (DCR) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04698941, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in