Pembrolizumab Plus Amurubicin in Patients With Refractory Small-cell Lung Cancer

NCT03253068 | Unknown Phase 2 DMC

• 1 other identifier: MK-3475-IIT-55441
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the overall response rate (ORR) per RECIST 1.1 as assessed by investigators in subjects with refractory small cell lung cancer treated with pembrolizumab (Pembro) plus amurubicin (AMR).

Conditions

Small Cell Lung Cancer Extensive Stage

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Overall response rate will be assessed using RECIST ver1.1 by investigators

  Imaging will be performed every 6 weeks through study completion, an average of 6 months

Study Arms (1)

Pembrolizumab plus amurubicin

EXPERIMENTAL

Pembrolizumab 200mg/body plus amurubicin 40mg/m2, intravenous, every 3 weeks

Drug: Pembrolizumab plus amurubicin

Interventions

Pembrolizumab plus amurubicin DRUG

Pembrolizumab 200mg/body plus amurubicin 40mg/m2, intravenous, every 3 weeks

Also known as: Keytruda, calsed

Pembrolizumab plus amurubicin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a histologically or cytologically confirmed diagnosis of SCLC.
• Confirmed radiological relapse within 90 days from the last day of first-line chemotherapy.
• Have adequate tumor tissue sample to test PD-L1 immunohistochemistry.
• Have measurable disease based on RECIST 1.1 as determined by the site.
• Be ≥20 years of age on day of signing informed consent.
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group
• Have adequate organ function as indicated by the following laboratory values
• Is expected to live more than 90 days.
• Be willing and able to provide written informed consent/assent for the trial.
• Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours from registration.
• Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 5.7.2 - Contraception, for the course of the study through 120 days (or longer as specified by local institutional guidelines) after the last dose of study medication.
• Male subjects of childbearing potential must agree to use an adequate method of contraception as outlined in Section 5.7.2- Contraception, starting with the first dose of study therapy through 120 days (or longer as specified by local institutional guidelines) after the last dose of study therapy.

You may not qualify if:

• Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 30 days from registration.
• Is receiving systemic steroid therapy ≤ 3 days from registration or receiving any other form of immunosuppressive medication.
• Has received prior systemic cytotoxic chemotherapy, biological therapy, OR major surgery within 3 weeks of the first dose of trial treatment; received thoracic radiation therapy of \> 30 Gy within 6 months from registration.
• Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.
• Has symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
• Has had an allogeneic tissue/solid organ transplant.
• History of noninfectious pneumonitis that required steroids or current active pneumonitis, or any evidence of interstitial lung disease by CT scan.
• Has received or will receive a live vaccine within 30 days from registration.
• Has an active infection requiring intravenous systemic therapy and oral administration.
• Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
• Has known active Hepatitis B, or Hepatitis C.
• Has any history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
• Has Known history of serious allergy.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

Sponsors & Collaborators

• Wakayama Medical University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Wakayama Medical University

Wakayama, 641-8509, Japan

Location

Related Publications (1)

• Akamatsu H, Teraoka S, Hayashi H, Fujimoto D, Hayata A, Haratani K, Ozawa Y, Yoshida T, Iwasa T, Shimokawa T, Tomii K, Nakagawa K, Yamamoto N. Pembrolizumab Plus Amrubicin in Patients With Relapsed SCLC: Multi-Institutional, Single-Arm Phase 2 Study. JTO Clin Res Rep. 2021 May 18;2(7):100184. doi: 10.1016/j.jtocrr.2021.100184. eCollection 2021 Jul.

  PMID: 34590034 DERIVED

MeSH Terms

Interventions

pembrolizumab; amrubicin

Study Officials

• Hiroaki Akamatsu, M.D.

  Third Department of Internal Medicine, Wakayama Medical University

  PRINCIPAL INVESTIGATOR

• Nobuyuki Katakami, M.D., Ph.D.

  Division of Integrated Oncology, Institute of Biomedical Research and Innovation

  PRINCIPAL INVESTIGATOR

• Kazuhiko Nakagawa, M.D., Ph.D.

  Department of Medical Oncology, Kinki University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 12, 2017
• First Posted: August 17, 2017
• Study Start: August 1, 2017
• Primary Completion: December 28, 2020
• Study Completion: December 31, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)