Status:
COMPLETED
Trial to Evaluate Safety and Efficacy of Vinorelbine With Metronomic Administration in Combination With Atezolizumab as Second-line Treatment for Patients With Stage IV Non-small Cell Lung Cancer
Lead Sponsor:
University Hospital, Brest
Collaborating Sponsors:
Groupe Francais De Pneumo-Cancerologie
Roche Farma, S.A
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The majority of patients diagnosed with advanced NSCLC are treated with platinum-doublet chemotherapy regimens, except those harboring specific oncogenic drivers such as epidermal growth-factor-recept...
Eligibility Criteria
Inclusion
- Histologically confirmed NSCLC;
- Locally advanced and/or metastatic stage IV NSCLC (according to American Joint Committee on Cancers) or recurrent NSCLC);
- Patients without activating EGFR mutation or ALK rearrangement and ROS1 fusions.
- Subject has provided a formalin-fixed tumor-tissue sample of a tumor-lesion biopsy, either at the time of or after metastatic disease was diagnosed AND from a site not previously irradiated to assess for PDL1 status. Archived tissue may be acceptable or PDL1 status known;
- Progressive disease after first-line platinum-doublet-based chemotherapy according to RECIST V.1.1 with measurable lesion (RECIST V1.1);
- Age ≥18 years, either sex;
- Eastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2;
- Life expectancy exceeds 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, demonstrated by the following laboratory results within 3 weeks prior to teatment: Normal hepatic function: bilirubin \<1.5 × normal (N), Alanine aminotransferase and Aspartate aminotransferase \<2.5 × N or \<5 × N if liver metastasis is present;
- Normal renal function (calculated creatinine clearance ≥45 mL/min);
- Normal calcemia;
- Normal hematological function (polynuclear neutrophils \>1.5 G/L, platelets \>100 G/L and hemoglobin\>8g/dl);
- 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;
- Written informed consent to participate in the study
- Patient with social insurance
Exclusion
- ECOG PS \>2;
- Known hypersensitivity to immunotherapy;
- Small-cell lung cancer, bronchioloalveolar cancer, neuroendocrine cancer;
- Tumor harbors EGFR-sensitizing (activating) mutations or ALK translocations or ROS1 fusions and that justify treatment with targeted therapy ;
- Chemotherapy, hormonotherapy, immunotherapy or tyrosine-kinase inhibitors within the past 4 weeks prior to treatment with the trial drug;
- Radiotherapy (except bone or brain) within the past 3 months prior to baseline imaging;
- Medical contraindication to oral vinorelbine;
- Persistence of clinical adverse events with a grade \> 2 related to prior treatment;
- Active brain metastases (e.g. stable for \<4 weeks, no adequate previous radiotherapy, symptomatic, requiring anticonvulsants or corticosteroids)
- Concurrent radiotherapy, except for palliative bone irradiation.
- Other concurrent severe illnesses (congestive heart failure, unstable angina, significant arrhythmia or myocardial infarction \<12 months before study entry);
- Active or prior documented autoimmune or inflammatory disorders;
- Active B hepatitis, HIV infection …;
- Psychiatric or neurological disorders preventing the patient from understanding the nature of the trial;
- Grade-3 peripheral neuropathy;
- Uncontrolled infection;
- Interstitial lung disease or pneumonitis requiring steroid management;
- Corticosteroid therapy exceeding 10 mg/day;
- Other severe organic disorders not allowing inclusion in the trial;
- Malabsorption syndrome;
- Pregnancy or breast-feeding;
- Follow-up not possible; and incarcerated or institutionalized patients.
Key Trial Info
Start Date :
January 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03801304
Start Date
January 24 2019
End Date
February 23 2022
Last Update
May 12 2022
Active Locations (13)
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1
CH Aix en Provence
Aix-en-Provence, France
2
CHRU de Brest - Hôpital Morvan
Brest, France, 29609
3
CLCC Caen
Caen, France
4
CH de Créteil
Créteil, France, 94010