Non-small Cell Lung Cancer Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Clinical Trial to Evaluate the Efficacy and Safety of Fruquintinib Plus Best Supportive Care in Patients With Advanced Non-squamous Non-small Cell Lung Cancer
Verified date | February 2020 |
Source | Hutchison Medipharma Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial to evaluate the efficacy and safety of Fruquintinib plus best supportive care in patients with advanced non-squamous non-small cell lung cancer who failed to second-line standard chemotherapy.
Status | Completed |
Enrollment | 91 |
Est. completion date | February 10, 2017 |
Est. primary completion date | August 7, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Fully understand the study and sign the informed consent form voluntarily; 2. Histologically and/or cytologically diagnosed with local advanced and/or metastatic stage IIIB/IV non-squamous NSCLC; 3. Previously failed to two chemotherapy regimens(treatment failure is defined as disease progression or intolerable toxicity), patients with positive EGFR mutation permitted to treated by EGFR-TKI previously; patients with EGFR wild type or unknown whether or not treated by EGFR-TKI previously; 4. Aged 18-75 years (inclusive); 5. Body weight =40 kg; 6. Evident measurable lesion(s) (according to RECIST1.1); 7. ECOG Performance Status 0-1; 8. Expected survival >12 weeks Exclusion Criteria: 1. Treatment in another clinical trials in the past 3 weeks; or treatment with systemic anti-tumor chemotherapy, radiotherapy or biotherapy within 3 weeks prior to administration of the study drug; 2. Previous therapy with VEGF/VEGFR inhibitors; 3. Unrecovered from toxicity caused by previous anti-cancer treatment (CTCAE >grade 1), or not completely recovered from previous surgery; 4. Previous active brain metastasis (without radiotherapy previously, or symptoms stable < 4 weeks, or with clinical symptoms, or with medication to control symptoms); 5. Other malignancies except basal cell carcinoma or cervical carcinoma in situ in the past 5 years; 6. Uncontrolled clinical active infection, e.g. acute pneumonia and active hepatitis B; 7. Dysphagia or known drug malabsorption; 8. Present active duodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases or other conditions that may lead to gastrointestinal bleeding or perforation according to the investigators' judgment; or with a history of intestinal perforation or intestinal fistula; 9. Have evidence or a history of thrombosis or bleeding tendency, regardless of seriousness; 10. Stroke and/or transient ischemic attack within 12 months prior to enrollment; 11. Appropriate organ function. Patients with any of the following conditions will be excluded: - Absolute neutrophil count (ANC) <1.5×109/L, platelet <100×109/L or hemoglobin <9 g/dL within 1 week prior to enrollment; - Serum total bilirubin >1.5 upper limit of normal (ULN), alanine transaminase and aspartate transferase >1.5×ULN; ALT and AST > 3×ULN in patients with liver metastasis; - Electrolyte abnormality of clinical significance; - Blood creatinine >ULN and creatinine clearance <60 ml/min; - Urine protein 2+ or above, or 24 h urine protein quantification =1.0 g/24 h; - Activated partial thromboplastin time (APTT) or/and INR and prothrombin time (PT) >1.5×ULN (according to reference range in each clinical study center); 12. Uncontrolled hypertension, systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg with medication; or heart failure NYHA classification = grade 2; 13. Heart function evaluation: left ventricular ejection fraction <50% (echocardiography); 14. Acute myocardial infarction, severe/unstable angina or coronary bypass surgery within 6 months prior to enrollment; history of arterial thrombosis or deep venous thrombosis; 15. Skin wound, surgical site, wound site, severe mucosal ulcer or fracture without complete healing; 16. Female subjects who are pregnant or lactating or of child bearing potential with positive pregnancy test result before the first dose; 17. Patients with child bearing potential who or whose sexual partners are not willing to take contraceptive measures; 18. Any clinical or laboratory abnormalities unfit to participate in this clinical trial according to the investigator's judgment; 19. Serious psychological or psychiatric disorders which may affect subject compliance in this clinical study; 20. Allergy to Fruquintinib and/or excipient contained in trial drugs. |
Country | Name | City | State |
---|---|---|---|
China | 307 Hospital of PLA | Beijing | Beijing |
China | Beijing Cancer Hospital | Beijing | Beijing |
China | Beijing Chest Hospital | Beijing | Beijing |
China | The First Hospital of Jilin University | Changchun | Jilin |
China | West China Hospital | Chengdu | Sichuan |
China | Xi Nan Hospital, Third Military Medical University | Chongqing | Chongqing |
China | Guangdong General Hospital | Guangzhou | Guangdong |
China | The First Affiliated Hosptial of College of Medicine, Zhejiang University | Hangzhou | Zhejiang |
China | Linyi Tumor Hospital | Linyi | Shandong |
China | Nantong Tumor Hospital | Nantong | Jiangsu |
China | Shanghai Chest Hospital | Shanghai | Shanghai |
China | The Cancer Hospital of Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Hutchison Medipharma Limited | Shanghai Chest Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progressive free survival (PFS) | To compare the Progressive Free Survival (PFS) of Fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients advanced non-squamous NSCLC patients who failed to standard second-line chemotherapy according to RECIST 1.1 | measured every 4 weeks at first 2 cycles and every 8 weeks since the third cycle from randomization to disease progression, assessed up to one year | |
Secondary | Objective response rate (ORR) | To evaluate objective response rate (ORR) in the two groups according to RECIST 1.1 | measured every 4 weeks at first 2 cycles and every 8 weeks since the third cycle from randomization to disease progression, assessed up to one year | |
Secondary | Disease control rate (DCR) | To evaluate disease control rate (DCR) in the two groups according to RECIST 1.1 | measured every 4 weeks at first 2 cycles and every 8 weeks since the third cycle from randomization to disease progression, assessed up to one year | |
Secondary | Overall survival (OS) | To evaluate overall survival (OS) in the two groups | every 2 months from randomization to death, assessed up to one year | |
Secondary | safety and tolerability by incidence, severity and outcome of adverse events | To evaluate the safety and tolerability in the two groups by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.0. | From randomization to 30 days after last dose |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03087448 -
Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1 | |
Recruiting |
NCT05042375 -
A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Terminated |
NCT05414123 -
A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
|
||
Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
Recruiting |
NCT05919537 -
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
|
Phase 1 | |
Recruiting |
NCT05009836 -
Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
|
Phase 3 | |
Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03219970 -
Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
|
||
Recruiting |
NCT05949619 -
A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04054531 -
Study of KN046 With Chemotherapy in First Line Advanced NSCLC
|
Phase 2 | |
Withdrawn |
NCT03519958 -
Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
|
||
Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
Terminated |
NCT02580708 -
Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01871805 -
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1/Phase 2 | |
Terminated |
NCT04042480 -
A Study of SGN-CD228A in Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05919641 -
LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
|
||
Completed |
NCT03656705 -
CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma
|
Phase 1 |