Treatment of no squamous non small cell lung cancer
- Conditions
- o squamous non small cell lungMedDRA version: 18.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-000475-27-FR
- Lead Sponsor
- CHU de Limoges
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 59
•Histologically confirmed non-squamous NSCLC,
•Locally advanced and/or metastatic NSCLC of stage IV (according to American Joint Committee on Cancers) or recurrent NSCLC)
•Patients without activating EGFR mutation
•Patients without 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 (WHO, Appendix C).
•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.
•No ongoing treatment related toxicity due to prior treatment > grade I (except alopecia).
•Adequate organ function, evidenced by the following laboratory results within 3 weeks prior to randomization: Normal hepatic function: bilirubin < 1.5 x N, ALAT and ASAT < 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 LMWH is authorized.
•Antiplatelet treatment (aspirin authorized if < 325 mg/d)
•Treatment with dipyridamole, ticlopidine, clopidogrel and/or cilostazol is not authorized
•Women of child bearing potential must use effective contraception.
•Men might be surgically sterile or accept to use an effective contraceptive procedure during and until 6 months after the treatment.
oWritten informed consent to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34
Known hypersensitivity to the trial drugs (nintedanib, docetaxel), to their excipients or to contrast media
•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 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-, hormono-, 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.
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy of the the nintedanib- docetaxel combination in second-line treatment in patients with no squamous non small cell lung cancer refractory to first line chemotherapy;Secondary Objective: - To assess toxicities and feasibility <br>-To evaluate tolerability during treatment <br>- To assess overall survival, overall response rate, and quality of life <br>- To assess progression free survival in patients according to disease progression at 2 or 4 cycles of first line treatment<br>;Primary end point(s): Median progression free survival at 12 weeks ;Timepoint(s) of evaluation of this end point: 12 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - To assess toxicities and feasibility <br>- To evaluate tolerability during treatment <br>- To assess overall survival, overall response rate, and quality of life <br>- To assess progression free survival in patients according to disease progression at 2 or 4 cycles of first line treatment.<br>;Timepoint(s) of evaluation of this end point: To evaluate tolerability during treatment: every 3 weeks <br>- To assess overall survival, overall response rate: at 12 month <br>-To assess and quality of life:every 6 weeks <br>- To assess progression free survival in patients according to disease progression at 2 or 4 cycles of first line treatment.<br><br>ach cycle