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

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ClinicalTrials.gov Identifier: NCT03083743
Recruitment Status : Unknown
Verified February 2017 by Shanghai Gebaide Biotechnology Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : March 20, 2017
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Shanghai Gebaide Biotechnology Co., Ltd.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Non-small-cell Lung Cancer (NSCLC) Stage IV Biological: Recombinant human Apo-2 ligand for Injection Biological: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 417 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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 Name: 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 Name: Mimetic for recombinant human Apo-2 ligand for injection




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. Quality of Life (QoL) [ Time Frame: An evaluation is made every 3 weeks and until 30 days after the last medication ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083743


Locations
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China, Beijing
Cancer Hospital,Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
Sponsors and Collaborators
Shanghai Gebaide Biotechnology Co., Ltd.
Investigators
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Principal Investigator: Yuankai Shi, Ph.D. Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Additional Information:
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Responsible Party: Shanghai Gebaide Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03083743     History of Changes
Other Study ID Numbers: 2016L04304
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: February 2017

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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

Keywords provided by Shanghai Gebaide Biotechnology Co., Ltd.:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Thoracic Neoplasms
Neoplasms
Lung Diseases
Antineoplastic Agents, Cytokines
Antineoplastic Agents
Biological activity factor
Genetic Engineering
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action