Non-small-cell Lung Cancer (NSCLC) Stage IVPhase 3NCT03083743
A Phase III Trial of Recombinant Human Apo-2 Ligand for Injection
A Phase 3 study testing Recombinant human Apo-2 ligand for Injection in people with Non-small-cell Lung Cancer (NSCLC) Stage IV, run by Shanghai Gebaide Biotechnology Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small-cell Lung Cancer (NSCLC) Stage IV
- What is being tested?
- Recombinant human Apo-2 ligand for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 417 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Jun 2018
- Phase
- Phase 3
- 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
- Age: 18 to 75 years old
- 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)
- 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)
- 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.
- ECOG status 0-1
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- Expected survival ≥ 3 months
- 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
- 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):
- Hemoglobin（HB） ≥ 90 g/L
- Absolute neutrophil count（ANC） ≥ 1.5 × 10（9）/L
- Platelets（PLT ）≥ 80 × 10（9）/L
- Biochemical test shall comply with the criteria as follows:
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- Total bilirubin（TBIL） < 1.5 × upper limit of normal（ULN）
- Alanine aminotransferase （ALT） and aspartate aminotransferase（AST） <2.5 × ULN; and < 5 × ULN for patients with liver metastases
- Serum Cr ≤ 1.25 × ULN or endogenous creatinine clearance > 45 ml / min (Cockcroft-Gault formula)
- 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
- Subjects shall participate in the study out of their own will, sign the informed consent, have good compliance, and cooperate with follow-up
- -
Who cannot join
- Small cell lung cancer (including small cell carcinoma and mixed non-small cell lung cancer)
- Patients who have a definitive history of severe allergy to biological products
- 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)
- 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)
- Patients with Grade III to IV heart dysfunction according to NYHA or left ventricular ejection fraction (LVEF) <50% identified in cardiac ultrasound examination
- Patients with persistent bradycardia and positive results in the atropine test
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- Patients with diseases concerning hemorrhagic tendency
- Dropsy of serous cavity (including pleural effusion, ascites, and pericardial effusion) presenting clinical symptoms and requiring medical treatment
- Patients with active hepatitis B or hepatitis C
- Patients with active infection requiring anti-microbial treatment (such as antibiotics, antiviral drugs, and antifungal drugs)
- Patients with a history of psychotropic drug abuse and failure to get rid of those drugs or who have mental disorders
- Patients who have participated in other clinical trials regarding anti-tumor drugs within 4 weeks prior to randomization
- Long-term users of adrenal cortex hormones or immunosuppressive agents
- 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
- Pregnant or breastfeeding women; fertile patients who are unwilling or unable to take effective contraceptive measures
- Patients with positive skin test results for injection of recombinant human Apo-2 ligand
- Other conditions as the researcher consider that may have impacts on the performance of the clinical trial and interpretation of results
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital，Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
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
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
- Being tested
- Recombinant human Apo-2 ligand for Injection, Placebo
- Keywords
- 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
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Bronchogenic, Bronchial Neoplasms, Lung Neoplasms, Thoracic Neoplasms, Neoplasms, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human Apo-2 ligand for InjectionBiological
Also called Dulanermin for injection
150μg/kg/d IV (in the vein), on day 1 to 7 of each 21 day cycle
PlaceboBiological
Also called Mimetic for recombinant human Apo-2 ligand for injection
150μg/kg/d IV (in the vein), on day 1 to 7 of each 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Recombinant human Apo-2 ligand | Experimental | Recombinant human Apo-2 ligand for Injection Receives: Biological: Recombinant human Apo-2 ligand for Injection |
| Placebo | Placebo comparator | Mimetic agent for recombinant human Apo-2 ligand for injection Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival（OS）
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.
Measured: From the date of randomization until the date of death from any cause, Assessed up to 36 months
Secondary outcomes (4)
Progression - free survival（PFS）
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.
Measured: 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)
Objective response rate: the percentage of subjects who have at least one visit response of CR or PR prior to any evidence of progression
Measured: Every 6 weeks (± 7 days) up to 36 months
Disease Control Rate (DCR)
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.
Measured: Every 6 weeks (± 7 days) up to 36 months
Quality of Life (QoL)
Measured: An evaluation is made every 3 weeks and until 30 days after the last medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small-cell Lung Cancer (NSCLC) Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Gebaide Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, Ph.D., Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083743
- Sponsor's protocol ID
- 2016L04304
- Status last verified
- Feb 2017
- First submitted
- 28 Feb 2017
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03083743
- Acronym / sponsor ID
- 2016L04304
- Keywords
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Bronchogenic, Bronchial Neoplasms, Lung Neoplasms, Thoracic Neoplasms, Neoplasms, Lung Diseases, Antineoplastic Agents, Cytokines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Shanghai Gebaide Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 20 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant human Apo-2 ligand | Experimental | Biological: Recombinant human Apo-2 ligand for InjectionRecombinant human Apo-2 ligand for Injection |
| Placebo | Placebo comparator | Biological: PlaceboMimetic agent for recombinant human Apo-2 ligand for injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age: 18 to 75 years old
- 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)
- 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)
- 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.
Key exclusion criteria (18 listed)
- Small cell lung cancer (including small cell carcinoma and mixed non-small cell lung cancer)
- Patients who have a definitive history of severe allergy to biological products
- 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)
- 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)
- Patients with Grade III to IV heart dysfunction according to NYHA or left ventricular ejection fraction (LVEF) <50% identified in cardiac ultrasound examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human Apo-2 ligand for InjectionAlso: Dulanermin for injection150μg/kg/d IV (in the vein), on day 1 to 7 of each 21 day cycle | Biological | Recombinant human Apo-2 ligand |
| PlaceboAlso: Mimetic for recombinant human Apo-2 ligand for injection150μg/kg/d IV (in the vein), on day 1 to 7 of each 21 day cycle | Biological | Placebo |
Primary outcome
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.
4 secondary outcomes
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
Objective Response Rate (ORR)
Time frame: Every 6 weeks (± 7 days) up to 36 months
Disease Control Rate (DCR)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- world cancer report 2014.WHO Keyword：Non-small Cell Lung CancerLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuankai Shi, Ph.D. principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant human Apo-2 ligand for Injection in people with Non-small-cell Lung Cancer (NSCLC) Stage IV, run by Shanghai Gebaide Biotechnology Co., Ltd. at 1 site 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 20 inclusion and 18 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 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival（OS） (time frame: From the date of randomization until the date of death from any cause, Assessed up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2017.