Trial to evaluate how severe the side effects are and how well the standard treatment works followed by Nivolumab in patients with advanced NSCLC.
- Conditions
- locally advanced stage IIIA/B NSCLCMedDRA version: 19.0Level: PTClassification code 10029520Term: Non-small cell lung cancer stage IIIASystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-005097-11-NL
- Lead Sponsor
- ETOP (European Thoracic Oncology Platform)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 43
- Histologically or cytologically confirmed non small cell lung cancer
- Locally advanced stage IIIA or III B (T0-3 N2-3 or T4N0-3 M0) NSCLC, according to 7th TNM classification.
- Nodal status N2 or N3 needs to be proven (by biopsy, EBUS, mediastinoscopy or thoracoscopy).
- Whole body FDG-PET CT, if feasible including a contrast-enhanced CT of thorax and upper abdomen (incl. liver, kidney, adrenals)
- brain MRI (preferred) or high-quality brain CT with intravenous contrast at the time of staging mandatory
within 28 days before enrolment.
- Measurable disease (according to RECIST v1.1 criteria)
- Age = 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Life expectancy > 3 months
- Adequate haematological function:
- WBC = 2000/µL
- haemoglobin = 9 g/dL
- neutrophil count = 1×109/L
- platelet count = 100 × 109/L
- Adequate liver function:
- Total bilirubin = 1.5 x ULN (except patients with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dl)
- ALT =3 × ULN
- alkaline phosphatase = 5 x ULN.
- Adequate renal function: Calculated creatinine clearance = 30 ml/min (according to Cockroft-Gault)
- Pulmonary function FEV1 of 1.0 l or > 40% predicted value and DLCO > 30% predicted value
- Patient capable of proper therapeutic compliance, and accessible to correct follow-up.
- Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before beginning chemo-radiotherapy (the test needs to be repeated within 24 hours before the start of nivolumab treatment).
- Written Informed Consent (IC) for trial treatment must be signed and dated by the patient and the investigator prior to any trial-related evalutation and/or intervention.
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 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21
- Patient with mixed small-cell and non-small-cell histologic features
- Patient with pleural or pericardial effusions proven to be malignant
- Prior chemotherapy, radiotherapy or molecular targeted therapy for NSCLC
- Patient who has an active, known or suspected autoimmune disease. Patients are permitted to enrol if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
- Patient who has had in the past 3 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ ductal carcinoma of the breast.
- Patient with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection and any other serious underlying medical processes that could affect the patient’s capacity to participate in the study.
- Ongoing clinically serious infections requiring systemic antibiotic or antiviral, antimicrobial, antifungal therapy.
- Known or suspected hypersensitivity to nivolumab or any of its excipients
- History of severe hypersensitivity reaction to any monoclonal antibody
- Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results.
- Established pathological diagnosis of underlying interstitial lung disease or pulmonary fibrosis
- Women who are pregnant or in the period of lactation
- Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method (two barrier methods or a barrier method plus a hormonal method) during the study treatment and for a period of at least 12 months following the last administration of trial drugs.
- Patients with any concurrent anticancer systemic therapy
- HIV, active Hepatitis B or Hepatitis C infection
- Previous radiotherapy to the thorax (prior to inclusion), including RT for breast cancer
- Planned radiotherapy to lung of mean dose > 20 Gy or V20 > 35 %
- Patient who received treatment with an investigational drug agent during the 3 weeks before enrolment in the trial
- Metastatic disease (brain MRI or high-quality CT with intravenous contrast at the time of staging mandatory)
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method