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

NCT02766140 | Terminated Phase 3 DMC

• 1 other identifier: HR-FMTN-II/III-NSCLC-COM
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Non Squamous Non Small Cell Lung

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  approximately 30 months

Secondary Outcomes (5)

• Progression Free Survival (PFS)

  approximately 30 months

• Incidence and Intensity of Adverse Events

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

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

  approximately 30months

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

  approximately 30months

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

  approximately 30months

Study Arms (2)

SHR1020 plus Docetaxel

EXPERIMENTAL

Drug: SHR1020 plus Docetaxel

Placebo plus Docetaxel

PLACEBO COMPARATOR

Drug: Placebo plus Docetaxel

Interventions

SHR1020 plus Docetaxel DRUG

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

SHR1020 plus Docetaxel

Placebo plus Docetaxel DRUG

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

Placebo plus Docetaxel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Interventions

famitinib; Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• caicun zhou, doctor

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: May 9, 2016
• Study Start: June 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 18, 2019

Record last verified: 2018-12

Locations

CN (1)