Lung Neoplasms Clinical Trial
— REFRACTOfficial title:
Multicenter Phase II Trial of Nintedanib (Vargatef®) Plus Docetaxel in Second Line of Treatment in Patients With no Squamous Non Small Cell Lung Cancer Refractory to First Line Chemotherapy
Verified date | July 2019 |
Source | University Hospital, Limoges |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether nintedanib (vargatef®) combined with docetaxel are effective in second line of treatment in patients with no squamous non small cell lung cancer refractory to first line chemotherapy.
Status | Completed |
Enrollment | 59 |
Est. completion date | September 26, 2020 |
Est. primary completion date | September 26, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histologically confirmed non-squamous NSCLC, - Metastatic NSCLC of stage IV (according to American Joint Committee on Cancers) or recurrent NSCLC) - Patients without activating epidermal growth factor receptor (EGFR) mutation - Patients without anaplastic lymphoma kinase (ALK) rearrangement - Patients must have measurable lesion by RECIST 1.1 - Refractory disease defined by documented progression during the first-line chemotherapy based on a platinum doublet and third-generation drug (four or less cycles) according to RECIST V.1.1 - Age =18 years and < 75 years - Performance status (PS) 0-1 - Life expectancy of more than 12 weeks. - No history of other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or basal cell or spinocellular carcinoma of the skin. - Adequate organ function, evidenced by the following laboratory results within 3 weeks prior to randomization: Normal hepatic function: bilirubin < 1.5 x N, ALT (alanine transaminase) and AST (aspartate aminotransferase ) < 2.5 x N or <5 x N in case of liver metastasis - Normal renal function (calculated creatinine clearance = 45 mL/min). - Normal Calcemia - Normal haematological function (polynuclear neutrophils > 1.5 G/l, platelets > 100 G/l). - Anticoagulation with a vitamin K antagonist and low-molecular-weight heparin (LMWH) is authorized. - Antiplatelet treatment (aspirin authorized if < 325 mg/d) - Treatment with dipyridamole, ticlopidine, clopidogrel is not authorized - Women of child bearing potential must use double effective contraception. - Men might be surgically sterile or accept to use an effective contraceptive procedure during and until 6 months after the treatment. - Written informed consent to participate in the study. Exclusion Criteria: - Known hypersensitivity to the trial drugs (nintedanib (vargatef®), docetaxel), peanut, soya, to their excipients - Controlled disease after first line treatment - Contra indication to the use of the backbone treatment - Patients who were withdrawn from first line treatment due to toxicity without documented disease progression or who received placebo (in the context of a clinical trial) as prior treatment are not eligible. - Previous treatment with docetaxel - Small-cell lung cancer, bronchioloalveolar cancer, neuroendocrine cancer. - Previous therapy with vascular endothelial growth factor (VEGF) inhibitors except bevacizumab - Centrally located tumour with radiographic evidence of local invasion of local blood vessels - Radiographic evidence of cavitary or necrotic tumours at screening - Chemo-, hormone-, radio-(except for brain and extremities) or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug. - Toxicity non resolute due to prior treatment > grade I (except alopecia). - Radiotherapy (except extremities) within the past 3 months prior to baseline imaging - Persistence of clinically relevant therapy related toxicity from previous radiotherapy - Active brain metastases (e.g. stable for <4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before inclusion). - Uncontrolled arterial hypertension. - Concurrent radiotherapy, except for palliative bone irradiation. - Other concurrent severe illnesses (congestive heart failure, unstable angina, significant arrhythmia or myocardial infarction less than 12 months before study entry). - Stroke less than 6 months before study entry. - Psychiatric or neurological disorders preventing the patient from understanding the nature of the trial - Grade >=1 peripheral neuropathy - Uncontrolled infection. - Caval syndrome - Other organic disorders preventing inclusion in the trial - Malabsorption syndrome - Pregnancy and breast-feeding - Surgery less than two months before study entry. - Follow-up not feasible. - Incarcerated and institutionalized |
Country | Name | City | State |
---|---|---|---|
France | CH de Beauvais | Beauvais | |
France | CHU Brest | Brest | |
France | Service de Pneumologie | Créteil | |
France | Service de Pneumologie | Gap | |
France | CHU de Limoges | Limoges | |
France | CH de Bretagne Sud | LOrient | |
France | Centre Hospitalier F. Quesnay | Mantes La Jolie | |
France | AP-HM | Marseille | |
France | Institut Paoli-Calmettes | Marseille | |
France | Instiut de Cancérologie | Saint Etienne | |
France | Service de Pneumologie | Villefranche |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Limoges | Boehringer Ingelheim |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | median progression free survival | 12 weeks | ||
Secondary | median progression free survival | 12 month | ||
Secondary | Toxicity (NCIC-CTC version 4.0 criteria) | Every 3 weeks during treatment up to 12 months from inclusion | ||
Secondary | Quality of life (EQ5-D questionnaire) | every 6 weeks up to 12 months from inlcusion | ||
Secondary | Response rate | 12 month |
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