stage III unresectable non-small cell lung cancer (NSCLC) MedDRA version: 21.1 Level: PT Classification code 10029519 Term: Non-small cell lung cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: durvalumab
Product Code: [MEDI4736]
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: durvalumab
CAS Number: 1428935-60-7
Current Sponsor code: ME
Sponsors
FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. 2 Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses. 3 18 years or older at the time of signing the ICF. 4 Histologically- or cytologically-documented NSCLC with locally-advanced, unresectable Stage III disease (according to the IASLC Staging Manual Version 8 [IASLC 2016]). Positron emission tomography (PET)/CT, MRI of the brain, and endobronchial ultrasound with biopsy are highly encouraged at diagnosis. 5 Patients with measurable disease assessed at baseline by CT/MRI will be entered in this study. 6 Must have a life expectancy of at least 12 weeks at enrolment. 7 WHO/ECOG PS 0-1. 8 Patient not eligible for concurrent chemo radiation according to investigator assessment 9 Adequate organ and marrow function at enrollment as defined below. 10 Body weight >30 kg at enrollment 11 Male or female. 12 Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: (a) Women 1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy). 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 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 33
Exclusion criteria
Exclusion criteria: 1 Patients who have disease considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumors. 2 Mixed small-cell lung cancer and NSCLC histology. 3 History of allogeneic organ transplantation. 4 Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion: (a) Patients with vitiligo or alopecia. (b)Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement. (c) Any chronic skin condition that does not require systemic therapy. (d)Patients without active disease in the last 5 years at enrolment may be included but only after consultation with the Study Physician. (e)Patients with celiac disease controlled by diet alone. 5 Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, ILD, serious chronic GI conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent. 6 History of another primary malignancy except for: (a) Malignancy treated with curative intent and with no known active disease =5 years before the first dose of IP and of low potential risk for recurrence. (b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. (c) Adequately treated carcinoma in situ without evidence of disease. 7 History of leptomeningeal carcinomatosis. 8 History of active primary immunodeficiency. 9 Active infection including hepatitis B (known positive hepatitis B surface antigen [HbsAg] result), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies). Patients with a past or resolved hepatitis B virus (HBV) infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HbsAg) are eligible. Patients positive for hepatitis C antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA). 10 Any unresolved toxicity of NCI CTCAE Grade =2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. (a) Patients with Grade =2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician. (b) Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician. 11 Known allergy or hypersensitivity to durvalumab or any of the IP excipients. Prior/concomitant therapy 12 Prior chemo-radiotherapy for lung cancer. Prior surgical resection (ie, Stage I or II) is permitted. 13 Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. see protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess safety and tolerability of the proposed treatment strategy, as defined as proportion of patients with any Grade 3 and Grade 4 possibly related adverse events (PRAEs) within 6 months from the initiation of treatment;Secondary Objective: To assess the efficacy of the proposed treatment strategy in terms of Progression-Free Survival. Endpoints: ¿Median PFS according to RECIST 1.1 as assessed by the Investigator ¿PFS12 (12 months) according to RECIST 1.1 as assessed by the Investigator Other secondary objectives: ¿Median OS and OS12 (12 months) ¿Quality of life;Primary end point(s): Grade 3 and Grade 4 PRAEs;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Italy
Contacts
Public ContactU.O.C. RADIOTERAPIA ONCOLOGICA
FONDAZIONE IRCCS POLICLINICO SAN MATTEO
Outcome results
None listed