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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02273375




Registration number
NCT02273375
Ethics application status
Date submitted
22/10/2014
Date registered
24/10/2014

Titles & IDs
Public title
Double Blind Placebo Controlled Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC
Scientific title
A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
IFCT1401
Secondary ID [2] 0 0
BR31
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: MEDI4736 - MEDI4736 by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier.

Placebo comparator: Placebo - PLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Compare Disease free survival (DFS) for patients with NSCLC that is PD-L1 expression TC = 25% and patients without common activating EGFR mutations or ALK gene rearrangements
Timepoint [1] 0 0
6.7 years
Secondary outcome [1] 0 0
Disease-free survival in the remaining 5 patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
Timepoint [1] 0 0
8 years
Secondary outcome [2] 0 0
Compare overall survival (OS) for patients in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
Timepoint [2] 0 0
8 years
Secondary outcome [3] 0 0
Compare Lung cancer specific survival for patients in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
Timepoint [3] 0 0
8 years
Secondary outcome [4] 0 0
Evaluate the nature, severity and frequency of adverse effects and tolerability of MEDI4736
Timepoint [4] 0 0
every 6 months
Secondary outcome [5] 0 0
Evaluate the Quality of life in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
Timepoint [5] 0 0
8 years
Secondary outcome [6] 0 0
Determine survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile
Timepoint [6] 0 0
8 years
Secondary outcome [7] 0 0
Determine the incremental cost effectiveness and cost utility ratios for MEDI4736
Timepoint [7] 0 0
8 years
Secondary outcome [8] 0 0
Evaluate the predictive/prognostic significance of PD-L1 expression
Timepoint [8] 0 0
8 years
Secondary outcome [9] 0 0
Evaluation of changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at disease event
Timepoint [9] 0 0
8 years
Secondary outcome [10] 0 0
Explore polymorphisms that may be associated with outcomes
Timepoint [10] 0 0
Baseline only

Eligibility
Key inclusion criteria
* Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung. according to WHO Classification of Tumours (WHO Classification of Tumours of the Lung, Pleura, Thymus and Heart. WHO/IARC Classification of Tumours, 4th Edition, Volume 7). Patients with large-cell neuroendocrine carcinomas are not eligible.
* Patients must be classified post-operatively as Stage IB (= 4cm in the longest diameter), II or IIIA on the basis of pathologic criteria. Note: Although T3N2M0 tumours have been reclassified to stage IIIB in the 8th edition of the IASLC staging system, these patients remain eligible (as stage IIIA under the 7th edition criteria).

* Complete surgical resection of the primary NSCLC is also mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour. Resection may be accomplished by open or VATS techniques

Note: Patients with synchronous primary tumours will not be eligible due to the potential uncertainty regarding their appropriate PD-L1 status.

Prior Systemic Therapy:

* Pre-operative (neo-adjuvant) platinum based or other chemotherapy is not permissible.
* Patients may have received prior post-operative platinum based chemotherapy as per standard of care.
* No prior anticancer therapy for treatment of NSCLC other than standard post-operative adjuvant chemotherapy is permissible.

Radiation:

• Patients with N2 disease only who receive adjuvant post-operative radiation therapy are eligible provided they meet the protocol specified timing criteria for surgery, adjuvant chemotherapy and randomization. Pre-operative radiation therapy is not permissible.

* The patient must have an ECOG performance status of 0, 1.
* Hematology: . Absolute neutrophil count = 1.5 x 109/L or = 1,500/µl Platelets = 100 x 109/L or = 100,000/µl
* Biochemistry:

Total bilirubin* = institutional upper limit of normal Alkaline phosphatase = 2.5 x institutional upper limit of normal AST(SGOT) and ALT(SGPT) = 2.5 x institutional upper limit of normal Creatinine Clearance = 40 ml/min

* excluding Gilbert's syndrome

Creatinine clearance to be measured directly by 24 hour urine sampling or as calculated by Cockcroft Formula:

Females: GFR = 1.04 x (140-age) x weight in kg serum creatinine in µmol/L Males: GFR = 1.23 x (140-age) x weight in kg serum creatinine in µmol/L

* Patient able and willing to complete the QoL, economics and other questionnaires. The baseline assessment must already have been completed within required timelines prior to randomization. Inability (illiteracy, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible
* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
* Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up
* Protocol treatment is to begin within 2 working days of patient randomization
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with a history of other malignancies, except:

* adequately treated non-melanoma skin cancer,
* curatively treated in-situ cancer, or
* other malignancies curatively treated with no evidence of disease for = 5 years following the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.
* A combination of small cell and non-small cell lung cancer, pulmonary carcinoid tumour or large-cell neuroendocrine carcinoma (LCNEC).
* History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. NOTE: patients with Grave's disease and/or psoriasis not requiring systemic therapy within the last two years from randomization and patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement are not excluded.
* History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization* or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.
* Live attenuated vaccination administered within 30 days prior to randomization.
* History of hypersensitivity to MEDI4736 or any excipient.
* Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, must have a LVEF > 50% within 12 weeks prior to randomization.
* Concurrent treatment with other investigational drugs or anti-cancer therapy.
* Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol. This includes but is not limited to:

* known clinical diagnosis of tuberculosis;
* known active hepatitis B infection (positive HBV surface antigen (HBsAg)). Patients with a past or resolved hepatitis B infection (defined as presence of hepatitis B core antibody (anti-HBc) and absence of HBSAg) are eligible;
* known active hepatitis C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA;
* known human immunodeficiency virus infection (positive HIV antibodies).
* known pneumonitis or pulmonary fibrosis with clinically significant impairment of pulmonary function
* Pregnant or lactating women. Women of childbearing potential must have a urine pregnancy test proven negative within 14 days prior to randomization. Men and women of child-bearing potential must agree to use adequate contraception.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
Accrual to date
Final
1415
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,South, QLDTAS,VIC,WA
Recruitment hospital [1] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
Coffs Habour Health Campus - NCCI - Coffs Harbour
Recruitment hospital [4] 0 0
Gosford Hospital - Gosford
Recruitment hospital [5] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [6] 0 0
St. George Hospital, Cancer Care Centre - Kogarah
Recruitment hospital [7] 0 0
Liverpool Cancer Therapy Centre, Liverpool Hospital - Liverpool
Recruitment hospital [8] 0 0
Northern Cancer Institute St Leonards - St Leonards
Recruitment hospital [9] 0 0
Westmead Hospital - Westmead
Recruitment hospital [10] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [11] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [12] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [13] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [14] 0 0
Mater Medical Centre - Brisbane
Recruitment hospital [15] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [16] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [17] 0 0
Frankston Hospital - Peninsula Oncology Centre - Frankston
Recruitment hospital [18] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [19] 0 0
Royal Melbourne Hospital Research Foundation - Parkville
Recruitment hospital [20] 0 0
Epworth HealthCare - Richmond - Richmond
Recruitment hospital [21] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [22] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [23] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment hospital [24] 0 0
St John of God Subiaco - Subiaco
Recruitment hospital [25] 0 0
Flinders Medical Center - Adelaide
Recruitment hospital [26] 0 0
Canberra Hospital - Garran
Recruitment hospital [27] 0 0
St. Vincent's Hospital - Victoria Park
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [4] 0 0
2250 - Gosford
Recruitment postcode(s) [5] 0 0
2751 - Kingswood
Recruitment postcode(s) [6] 0 0
2217 - Kogarah
Recruitment postcode(s) [7] 0 0
2170 - Liverpool
Recruitment postcode(s) [8] 0 0
2065 - St Leonards
Recruitment postcode(s) [9] 0 0
2145 - Westmead
Recruitment postcode(s) [10] 0 0
4575 - Birtinya
Recruitment postcode(s) [11] 0 0
4102 - Brisbane
Recruitment postcode(s) [12] 0 0
4032 - Chermside
Recruitment postcode(s) [13] 0 0
5000 - Adelaide
Recruitment postcode(s) [14] 0 0
4101 - Brisbane
Recruitment postcode(s) [15] 0 0
7000 - Hobart
Recruitment postcode(s) [16] 0 0
3168 - Clayton
Recruitment postcode(s) [17] 0 0
3199 - Frankston
Recruitment postcode(s) [18] 0 0
3084 - Heidelberg
Recruitment postcode(s) [19] 0 0
3050 - Parkville
Recruitment postcode(s) [20] 0 0
3121 - Richmond
Recruitment postcode(s) [21] 0 0
3690 - Wodonga
Recruitment postcode(s) [22] 0 0
6150 - Murdoch
Recruitment postcode(s) [23] 0 0
6009 - Perth
Recruitment postcode(s) [24] 0 0
6008 - Subiaco
Recruitment postcode(s) [25] 0 0
5042 - Adelaide
Recruitment postcode(s) [26] 0 0
ACT 2605 - Garran
Recruitment postcode(s) [27] 0 0
3065 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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North Carolina
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United States of America
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Pennsylvania
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Brazil
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Ceara
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Brazil
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Espirito Santo
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Brazil
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Minas Gerais
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Brazil
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Rio Grande Do Norte
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Brazil
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Rio Grande Do Sul
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Brazil
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Santa Catarina
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Brazil
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Santo Andre
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Brazil
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Sao Paulo
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Brazil
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Rio de Janeiro
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Bulgaria
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Sofia
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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New Brunswick
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Canada
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Newfoundland and Labrador
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Prince Edward Island
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Canada
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Quebec
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Canada
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Saskatchewan
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China
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Beijing
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China
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Fujian
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China
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Guangdong
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China
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Guangxi
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China
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Henan
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China
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Hunan
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China
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Jiangsu
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China
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Shandong
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China
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Shanghai
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China
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Yunnan
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China
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Zhejiang
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France
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BP
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Cedex 04
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Tours Cedex 9
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Avignon
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Bobigny
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Bordeaux
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Boulogne
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Caen
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Chambery
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Cholet
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Clamart
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Clermont-Ferrand
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Colmar
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Contamine Sur Arve
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Corbeil-Essonnes
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Creteil
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France
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Dijon
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France
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Elbeuf
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France
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La Roche Sur Yon
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France
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Le Chesnay
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France
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Le Mans
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Lille
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Lyon
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Macon
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Marseille
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Metz-Tessy
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Mulhouse
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Nice
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Orleans
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Paris Cedex 5
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Paris
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Pau
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Perigueux
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Pontoise
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Rouen
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Saint-priest-en-jarez
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Saint-Quentin
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Strasbourg
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Suresnes
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Thonon Les Bains
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Toulon
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Toulouse
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France
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Villefranche Sur Saone
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Hungary
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Budapest
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Italy
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AN
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Italy
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AV
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Italy
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BA
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Italy
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Lombardia
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Italy
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MI
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Italy
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PG
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Italy
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PN
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Italy
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PV
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Italy
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RA
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Italy
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RE
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Italy
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RM
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Italy
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VA
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Italy
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VR
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Italy
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Benevento
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Italy
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Brindisi
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Italy
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Catania
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Italy
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Genova
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Italy
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Meldola
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Italy
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Milan
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Italy
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Mirano
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Italy
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Napoli
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Italy
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Padova
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Italy
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Piacenza
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Italy
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Rome
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Gifu
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Japan
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Gunma
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Japan
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Hiroshima
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Japan
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Hyogo
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Japan
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Ishikawa
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Japan
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Miyagi
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Tottori
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Japan
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Yamaguchi
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Japan
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Tokyo
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Japan
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Yokohama City
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Korea, Republic of
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Chungcheongbuk Do
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Korea, Republic of
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Dalseogu
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Korea, Republic of
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Dongjak Gu
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Korea, Republic of
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Gangdong-gu
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Korea, Republic of
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Gyeonggi Do
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Netherlands
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Gelderland
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Netherlands
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Noord Brabant
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Netherlands
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Noord Holland
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Netherlands
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Overijssel
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Netherlands
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Amsterdam
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Netherlands
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Groningen
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Netherlands
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Maastricht
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Netherlands
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Rotterdam
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New Zealand
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Christchurch
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Poland
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Gdansk
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Poland
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Szczecin
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Poland
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Zakopane
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Romania
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Bucharest
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Romania
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Cluj-Napoca
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Romania
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Constanta
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Romania
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Craiova
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Romania
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Ploiesti
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Gran Canaria
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Spain
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Alicante
Country [156] 0 0
Spain
State/province [156] 0 0
Coruna
Country [157] 0 0
Spain
State/province [157] 0 0
Leon
Country [158] 0 0
Spain
State/province [158] 0 0
Madrid
Country [159] 0 0
Spain
State/province [159] 0 0
Palma de Mallorca
Country [160] 0 0
Spain
State/province [160] 0 0
Salamanca
Country [161] 0 0
Spain
State/province [161] 0 0
Valencia
Country [162] 0 0
Taiwan
State/province [162] 0 0
Taiwan;
Country [163] 0 0
Taiwan
State/province [163] 0 0
Chiayi City
Country [164] 0 0
Taiwan
State/province [164] 0 0
Kaohsiung City
Country [165] 0 0
Taiwan
State/province [165] 0 0
Kaohsiung
Country [166] 0 0
Taiwan
State/province [166] 0 0
New Taipei City
Country [167] 0 0
Taiwan
State/province [167] 0 0
Taichung
Country [168] 0 0
Taiwan
State/province [168] 0 0
Taipei
Country [169] 0 0
Taiwan
State/province [169] 0 0
Taoyuan
Country [170] 0 0
Ukraine
State/province [170] 0 0
Dnipropetrovsk
Country [171] 0 0
Ukraine
State/province [171] 0 0
Sumy
Country [172] 0 0
Ukraine
State/province [172] 0 0
Vinnitsia

Funding & Sponsors
Primary sponsor type
Other
Name
Canadian Cancer Trials Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Intergroupe Francophone de Cancerologie Thoracique
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Thoracic Oncology Group of Australasia (TOGA)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
National Health and Medical Research Council, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
National Cancer Institute (NCI), Naples
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Central and Eastern European Oncology Group
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Dutch Society of Physicians for Pulmonology and Tuberculosis
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Korean Cancer Study Group
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Fundación GECP
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
West Japan Oncology Group (WJOG)
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Chinese Thoracic Oncology Group
Address [10] 0 0
Country [10] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Glenwood Goss
Address 0 0
Ottawa Hospital Research Institute, Ontario, Canada
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02273375