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Non Squamous Non Small Cell LungPhase 3NCT02766140

SHR1020 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Squamous Non Small Cell Lung Cancer

A Phase 3 study testing SHR1020 plus Docetaxel in people with Non Squamous Non Small Cell Lung, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The present trial will be performed to evaluate whether SHR1020 in combination with docetaxel in patients with Local Advanced or Metastatic or recurrent Non Squamous NSCLC is more effective as compared to placebo in combination with docetaxel. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Non Squamous Non Small Cell Lung
What is being tested?
SHR1020 plus Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteChina
Study dates
Jun 2016to Nov 2016
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age:18-70 years
  • Histologically or cytologically confirmed locally advanced and/or metastatic NSCLC or recurrent NSCLC (≤9 months from date of diagnosis to randomized ), epidermal growth factor receptor-wild type, Anaplastic Lymphoma Kinase-wild type or unknown mutation
  • At least one lesion that can be accurately measured and has not been received local treatments such as radiotherapy and cryotherapy
  • Relapse or failure of one first line prior platinum-based chemotherapy
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Life expectancy of at least 12 weeks
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  • Adequate organ and bone marrow function as defined below(no blood transfusion or drugs for leucopenia and Platelet within 14 days before screening): (1) HB≥90g/l (2) ANC≥1.5×10^9/l (3) PLT≥100×10^9/l (4) BIL<1.25×upper limit of normal (5) Alanine Aminotransferase and/or AST<2.5×upper limit of normal (< 5×upper limit of normal for patients with liver metastasis) (6) Cr≤1.25×upper limit of normal or Creatinine clearance rate>45ml/min ( Cockcroft-Gault Formula) (7) Cholesterol≤1.5×upper limit of normal, Triglyceride≤2.5×upper limit of normal (8) Left ventricular ejection fraction (LVEF) greater than lower limit of normal
  • Female: child bearing potential, a negative urine or serum pregnancy test result within 7 days before randomisation, agree to use effective contraception while on treatment and for at least 6 months after end of treatment;male: agree to use effective contraception while on treatment and for at least 6 months after end of treatment
  • Patient has given written informed consent

Who cannot join

  • More than one prior chemotherapy regimen for advanced and/or metastatic or recurrent NSCLC (except neoadjuvant or adjuvant chemotherapy )
  • Previous therapy with other VEGFR inhibitors、recombinant human endostatin、 docetaxel or immunotherapy for treatment of NSCLC
  • History of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80 (Tween 80), Hypersensitivity to the excipients of the trial drugs or contrast medium
  • Have clinically significant cavity effusion,such as pleural effusion、 pericardial effusion or ascites and require clinical intervention
  • Active brain metastases
  • Other malignancy within the past (including primary brain tumor or Leptomeningeal tumor), other than basal cell skin cancer or carcinoma in situ of the cervix
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  • Significant weight loss (>10%) within the past 6 weeks
  • Persistence of clinically relevant therapy related toxicities from previous therapy (greater than Common Terminology Criteria for Adverse Event(CTCAE) 4.0 grade 1)
  • Treatment with surgery, chemotherapy, hormone therapy, radiotherapy, immunomodulation or monoclonal antibody therapy within the past 4 weeks and traditional chinese medicine for antitumor therapy within the past 2 weeks before start of therapy
  • Radiographical evidence of cavitary or necrotic tumours
  • Centrally located tumours with radiographical evidence (CT or MRI) of local invasion of major blood vessels
  • Greater than CTCAE 4.0 grade 2 pulmonary hemorrhage within the past one month before screening
  • History of clinically significant haemoptysis within the past 3 months (more than half a teaspoon within 24 hours )
  • History of major thrombotic or clinically relevant major bleeding event in the past 6 months
  • Prothrombin time (PT) and/or partial thromboplastin time (PTT) > 50% of devi
  • ation of upper limit of normal
  • Application of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogus, if INR≤1.5, with the purpose of prevention,the use of low-dose warfarin (1mg, qd) or aspirin ( ≤ 100 mg per day ) is allowed
  • Incomplete wound healing or fracture for long time
  • Uncontrolled hypertensin with one antihypertensive agent, unstable angina, history of myocardial infarction in the past 6 months, congestive heart failure>NYHA II, serious cardiac arrhythmia
  • Urinary protein≥++ and confirmed 24-hour urinary protein greater than 1.0g;
  • Preexisting thyroid dysfunction, even with medical therapy, thyroid function can not be maintained in the normal range
  • Uncontrolled diabetes mellitus with antidiabetic therapy
  • Current peripheral neuropathy greater than CTCAE 4.0 grade 2
  • Active or chronic hepatitis C and/or B infection with liver dysfunction
  • History of immunodeficiency diseases, other acquired or congenital immunodeficiency diseases, or history of organ transplantation
  • Serious infections requiring systemic antibiotic therapy
  • Variety of factors that affect the oral medication (such as unable to swallow, chronic diarrhea, bowel obstruction and other gastrointestinal disorders or abnormalities
  • Pregnancy or breast feeding
  • Active alcohol or drug abuse
  • Treatment in another clinical trial within the past 4 weeks before start of therapy
  • Psychological, familial, sociological, or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
  • According to the investigator, other conditions that may increase the risk associated with patient safety and study participation

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

Other trials in China

About this study

Official title: Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral SHR1020 Plus Docetaxel Therapy Compared to Placebo Plus Docetaxel Therapy in Patients With Local Advanced or Metastatic or Recurrent Non Squamous Non Small Cell Lung Cancer After Failure of First Line Chemotherapy.

The present trial will be performed to evaluate whether SHR1020 in combination with docetaxel in patients with Local Advanced or Metastatic or recurrent Non Squamous NSCLC is more effective as compared to placebo in combination with docetaxel. A secondary aim is to obtain safety information as well as information on quality of life of patients treated with SHR1020 in combination with docetaxel.

Being tested
SHR1020 plus Docetaxel, Placebo plus Docetaxel

What participants receive

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

  • SHR1020 plus DocetaxelDrug

    SHR1020 20mg qd 2-21days, Docetaxel 60 mg/m^2 IV Day1/3weeks

  • Placebo plus DocetaxelDrug

    Placebo matching SHR1020 qd 2-21days, Docetaxel 60 mg/m^2 IV Day1/3weeks

Study groups in NCT02766140
Study groupRoleWhat they receive
SHR1020 plus DocetaxelExperimentalNot described
Receives: Drug: SHR1020 plus Docetaxel
Placebo plus DocetaxelPlacebo comparatorNot described
Receives: Drug: Placebo plus Docetaxel

What is being measured

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

  1. Overall Survival

    Measured: approximately 30 months

Secondary outcomes (5)

  1. Progression Free Survival (PFS)

    Measured: approximately 30 months

  2. Incidence and Intensity of Adverse Events

    Measured: From signing informed consent document until 30 days after the last drug administration

  3. Objective Tumour Response (Complete Response Plus Partial Response) Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Measured: approximately 30months

  4. Disease Control (Complete Response Plus Partial Response plus stable disease) Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Measured: approximately 30months

  5. Quality of Life (QoL) measured by standardised questionnaires (EORTC Quality of Life Questionnaire-C30)

    Measured: approximately 30months

Timeline

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

  1. First posted9 May 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionNov 2016
  4. Study completionNov 2016

Why it stopped: difficulty in recruitment

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02766140
Sponsor's protocol ID
HR-FMTN-II/III-NSCLC-COM
Status last verified
Dec 2018
First submitted
18 Apr 2016
Last updated
18 Jan 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SHR1020 plus Docetaxel in people with Non Squamous Non Small Cell Lung, run by Jiangsu HengRui Medicine 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 9 inclusion and 32 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: stopped early, as of the sponsor's last update on 18 Jan 2019. 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?

The study was stopped early (reason given: difficulty in recruitment). 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 (time frame: approximately 30 months). 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 NCT02766140.

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 18 Jan 2019.

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