A Phase III Trial of Recombinant Human Apo-2 Ligand for Injection

March 13, 2017 updated by: Shanghai Gebaide Biotechnology Co., Ltd.

A Randomized, Double-blind, Placebo-controlled in Parallel, Multicenter Phase III Trial of Recombinant Human Apo-2 Ligand for Injection（Dulanermin for Injection）in the Treatment of Advanced Non-small Cell Lung Cancer

The trial is to evaluate the efficacy and safety of recombinant human Apo-2 ligand in treating patients with advanced retreated non-small cell lung cancer

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

417

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Cancer Hospital,Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: 18 to 75 years old
  2. Pathologically diagnosed advanced non-small cell lung cancer (stage Ⅳ) with measurable lesions (diameter of tumor lesions displayed on CT scan ≥ 10 mm; short diameter of lymph node lesions on CT scan ≥ 15 mm; and no radiotherapy, radiofrequency ablation or other local treatment has been given to such measurable lesions)
  3. Patients with negative EGFR or ALK gene-sensitive mutations or unknown status and with treatment failure or recurrence after previously undergoing the treatment with two chemotherapy regimens (at least one platinum-containing two-drug regimen included)

  4. Patients with positive EGFR-TKI or ALK-TKI gene-sensitive mutations and with treatment failure or recurrence after previously undergoing one platinum-containing chemotherapy regimen may be included. Note that treatment given in neo-adjuvant therapy phase is not considered a part of the treatment regimen; however, if recurrence occurred within 6 months after the end of adjuvant therapy, the adjuvant therapy is considered a part of the treatment regimen, and if not within such 6 months, the adjuvant therapy is not considered a part of the treatment regimen.

    The term "treatment failure" is defined as: (1) progression presents in the course of treatment or after the last treatment with evidence of definitive imaging or clinical progression; (2) patients withdrawn from standard treatment due to inability to tolerate adverse events of grade IV and above hematological toxicity, of grade II and above non-hematological toxicity or of grade II and above major organ damage, such as heart, liver and kidney according to NCI-CTCAE Version 4.0.

  5. ECOG status 0-1
  6. Expected survival ≥ 3 months
  7. Patients recovered from damages caused by other treatment given to them (≤ grade 1 according to NCI-CTCAE version 4.0); the interval of nitrosourea or mitomycin given was ≥ 6 weeks; the interval of other cytotoxic drugs, Avastin, radiotherapy or surgery was ≥ 4 weeks; and the interval of EGFR TKI molecular targeted drugs was ≥ 2 weeks

  8. Major organs function normally, e.g. the following criteria are met (1) Blood routine tests shall comply with the criteria as follows (no transfusion of blood or blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors):

    1. Hemoglobin（HB） ≥ 90 g/L
    2. Absolute neutrophil count（ANC） ≥ 1.5 × 10（9）/L

    3. Platelets（PLT ）≥ 80 × 10（9）/L

      (2) Biochemical test shall comply with the criteria as follows:

    1. Total bilirubin（TBIL） < 1.5 × upper limit of normal（ULN）
    2. Alanine aminotransferase （ALT） and aspartate aminotransferase（AST） <2.5 × ULN; and < 5 × ULN for patients with liver metastases
    3. Serum Cr ≤ 1.25 × ULN or endogenous creatinine clearance > 45 ml / min (Cockcroft-Gault formula)
  9. Female patients at a childbearing age must have taken reliable contraceptive measures or received pregnancy test (either by serum or urine) showing a negative result within 7 days before inclusion and are willing to take appropriate contraceptive measures during the trial and in the following 8 weeks after the last administration of the test drug. Male patients shall agree to take appropriate contraceptive measures or have undergone surgical sterilization during the trial and in the following 8 weeks after the last administration of the test drug

  10. Subjects shall participate in the study out of their own will, sign the informed consent, have good compliance, and cooperate with follow-up

    -

Exclusion Criteria:

  1. Small cell lung cancer (including small cell carcinoma and mixed non-small cell lung cancer)
  2. Patients who have a definitive history of severe allergy to biological products
  3. Patients with active (without medical control) brain metastases, cancer meningitis, spinal cord compression, or with brain or leptomeninges disorders identified in CT or MRI examination in the inclusion process (however, patients with brain metastases who have completed treatment 21 days prior to the randomization and maintained symptomatic stability may be included)
  4. Patients with Grade II and above myocardial ischemia or myocardial infarction and poorly controlled arrhythmia (including male patients with QTc interval ≥ 450 ms and female patients with QTc interval ≥ 470 ms)
  5. Patients with Grade III to IV heart dysfunction according to NYHA or left ventricular ejection fraction (LVEF) <50% identified in cardiac ultrasound examination
  6. Patients with persistent bradycardia and positive results in the atropine test
  7. Patients with diseases concerning hemorrhagic tendency
  8. Dropsy of serous cavity (including pleural effusion, ascites, and pericardial effusion) presenting clinical symptoms and requiring medical treatment
  9. Patients with active hepatitis B or hepatitis C
  10. Patients with active infection requiring anti-microbial treatment (such as antibiotics, antiviral drugs, and antifungal drugs)
  11. Patients with a history of psychotropic drug abuse and failure to get rid of those drugs or who have mental disorders
  12. Patients who have participated in other clinical trials regarding anti-tumor drugs within 4 weeks prior to randomization
  13. Long-term users of adrenal cortex hormones or immunosuppressive agents
  14. Patients with a history of or suffering from other non-cured malignancies, except for cured skin basal cell carcinoma, cervical carcinoma in situ and superficial bladder cancer
  15. Pregnant or breastfeeding women; fertile patients who are unwilling or unable to take effective contraceptive measures
  16. Patients with positive skin test results for injection of recombinant human Apo-2 ligand

  17. Other conditions as the researcher consider that may have impacts on the performance of the clinical trial and interpretation of results

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recombinant human Apo-2 ligand
Recombinant human Apo-2 ligand for Injection
Biological: Recombinant human Apo-2 ligand for Injection
150μg/kg/d IV (in the vein), on day 1 to 7 of each 21 day cycle
Other Names:
  • Dulanermin for injection
Placebo Comparator: Placebo
Mimetic agent for recombinant human Apo-2 ligand for injection
Biological: Placebo
150μg/kg/d IV (in the vein), on day 1 to 7 of each 21 day cycle
Other Names:
  • Mimetic for recombinant human Apo-2 ligand for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival（OS）
Time Frame: From the date of randomization until the date of death from any cause, Assessed up to 36 months
Survival information may be obtained via telephone contact with the patient, patients family or by checking the patients notes, hospital records, contacting the patients general practitioner or public death registry, where it is possible to do so under applicable local laws.
From the date of randomization until the date of death from any cause, Assessed up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression - free survival（PFS）
Time Frame: From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, evaluate once every six weeks (± 7 days) and assessed up to 36 months
Progression Free Survival (PFS) : the time from start of study treatment to the first documentation of objective disease progression (PD) or death from any cause.
From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, evaluate once every six weeks (± 7 days) and assessed up to 36 months
Objective Response Rate (ORR)
Time Frame: Every 6 weeks (± 7 days) up to 36 months
Objective response rate: the percentage of subjects who have at least one visit response of CR or PR prior to any evidence of progression
Every 6 weeks (± 7 days) up to 36 months
Disease Control Rate (DCR)
Time Frame: Every 6 weeks (± 7 days) up to 36 months
Disease control rate: the percentage of subjects who have at least one visit response of CR or PR or SD prior to any evidence of progression.
Every 6 weeks (± 7 days) up to 36 months
Quality of Life (QoL)
Time Frame: An evaluation is made every 3 weeks and until 30 days after the last medication
An evaluation is made every 3 weeks and until 30 days after the last medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Gebaide Biotechnology Co., Ltd.

Investigators

  • Principal Investigator: Yuankai Shi, Ph.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

February 28, 2017

First Submitted That Met QC Criteria

March 13, 2017

First Posted (Actual)

March 20, 2017

Study Record Updates

Last Update Posted (Actual)

March 20, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016L04304

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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