This is a Phase II, open-label, multi-centre study to determine the safety of a fixed dose of durvalumab in patients with Non-Small Cell Lung Cancer who have not progressed after sequential chemoradiation therapy.
- Conditions
- Patients with unresectable Stage III non-small cell lung cancer (NSCLC), who have not progressed following platinum-based sequential chemoradiation therapy (sCRT)MedDRA version: 21.1Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-002220-16-IT
- Lead Sponsor
- ASTRAZENECA AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 150
- Informed consent as detailed in the protocol.
- 18 years or older at the time of signing the ICF.
- 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.
- Receipt of sCRT which must have been completed within 42 days prior to first IP dose administration in the study as defined in the protocol.
- Patients must not have progressed following platinum-based sCRT, as per Investigator-assessed RECIST 1.1 criteria as defined in the protocol.
- Must have a life expectancy of at least 12 weeks at enrolment.
- WHO/ECOG PS =2.
- Adequate organ and marrow function at enrolment as defined in the protocol.
- Body weight >30 kg at enrolment and first IP dose administration.
- Male or female.
- 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. Age-specific requirements are detailed in the protocol.
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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 105
- Patients with locally-advanced NSCLC whose disease has progressed following platinum-based sCRT.
- Patients who have disease considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumours.
- Mixed small-cell lung cancer and NSCLC histology.
- History of allogeneic organ transplantation.
- 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]). Exceptions to this criterion are defined in the protocol.
- 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.
- History of another primary malignancy except for:
-- 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.
-- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
-- Adequately treated carcinoma in situ without evidence of disease.
- History of leptomeningeal carcinomatosis.
- History of active primary immunodeficiency.
- Active infection including tuberculosis, hepatitis B, hepatitis C virus (HCV), or human immunodeficiency virus (HIV). Patients with a past or resolved hepatitis B virus (HBV) infection are eligible. Patients positive for hepatitis C antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).
- 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. More details to be found in the protocol.
- Known allergy or hypersensitivity to durvalumab (MEDI4736) or any of the IP excipients.
- Patients who have received cCRT for locally-advanced NSCLC, or who received sCRT with at least 2 concomitant CRT cycles. Prior surgical resection (ie, Stage I or II) is permitted.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
- Prior exposure to immune-mediated therapy, including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of IP. Exceptions to this criterion are detailed in the protocol.
- Previous IP assignment in the present study.
- Concurrent enrolment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study.
- Participation in another clinical study with an IP during the 4 weeks prior to the first IP dose administration.
- Prior randomisation or treatment in a previous durvalumab (MEDI4736) ± tremelimumab clinical study regardless of tr
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