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Clinical Trials List

Protocol NumberD933YC00001
NCT Number(ClinicalTrials.gov Identfier)NCT03706690
Active

2018-12-01 - 2024-12-31

Phase III

Recruiting3

Terminated4

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Phase III, Randomised,Double-Blind,Placebo-Controlled,Study of Durvalumab as Consolidation Therapy in Patients With Locally Advanced,Unresectable NSCLC, Who Have Not Progressed Following Definitive, Platinum-Based Chemoradiation Therapy

  • Trial Applicant

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

3 Recruiting

Audit

CRO

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Liang Wang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 蔡鎮良 Division of Thoracic Medicine
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Jui-Hung Tsai Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Non-Small Cell Lung Cancer

Objectives

Primary objective: To assess the efficacy of durvalumab treatment compared with placebo in terms of PFS Key secondary objective: To further assess the efficacy of durvalumab compared with placebo in terms of OS Secondary objective: -To further assess the efficacy of durvalumab compared with placebo in terms of: OS24, ORR, DoR, PFS12, PFS18, PFS2, and TTDM -To assess the PK of durvalumab -To investigate the immunogenicity of durvalumab -To assess symptoms and health-related quality of life in patients treated with durvalumab compared with placebo using EORTC QLQ-C30 v3 and QLQ-LC13 -To investigate the relationship between a patient’s tissue TMB and efficacy outcomes with durvalumab -To investigate the relationship between a patient’s baseline tumour PD-L1 expression and efficacy outcomes with durvalumab compared with placebo

Test Drug

Durvalumab (MEDI4736)

Active Ingredient

Humanized anti-PD-1 mAb

Dosage Form

injection

Dosage

50 mg/mL

Endpoints

Primary Outcome Measures :
Progression-Free Survival (PFS) according to RECIST 1.1 in randomised patients [ Time Frame: from date of randomisation until disease progression, assessed up to 29months ]
To assess the efficacy of durvalumab treatment compared with placebo in terms of PFS


Secondary Outcome Measures :
The efficacy of durvalumab treatment compared to placebo in terms of Overall Survival (OS) in randomised patients [ Time Frame: from date of randomisation until the date of death, assessed up to 65 months ]
To further assess the efficacy of durvalumab compared with placebo in terms of OS

The efficacy of durvalumab treatment compared to placebo in terms of proportion of patients alive at 24 months (OS24) from randomisation. [ Time Frame: at 24 months from participants' randomisation. ]
To further assess the efficacy of durvalumab compared with placebo in terms of OS24

Objective Response Rate (ORR) assessed by BICR according to RECIST 1.1 in randomised patients [ Time Frame: from date of randomisation until progression, or the last evaluable assessment in the absence of progression, assessed up to 29months ]
To further assess the efficacy of durvalumab compared with placebo in terms of ORR.

Duration of Response (DoR) assessed by BICR according to RECIST 1.1 in randomised patients [ Time Frame: from date of randomisation until progression, or the last evaluable assessment in the absence of progression, assessed up to 29months ]
To further assess the efficacy of durvalumab compared with placebo in terms of DOR

Proportion of patients alive and progression free from randomisation to second progression (PFS2) as defined by local standard clinical practice [ Time Frame: from randomisation to second progression. assessed up to 65months ]
The date of PFS2 assessment and Investigator opinion of progression status (progressed or non-progressed) at each assessment will be recorded in the PFS2 eCRF.

Proportion of patients alive and progression free at 12 months from randomisation (PFS12) assessed by BICR according to RECIST 1.1 in randomised patients [ Time Frame: at 12 months from participants' randomisation. ]
To further assess the efficacy of durvalumab compared with placebo in terms of PFS12

Proportion of patients alive and progression free at 18 months from randomisation (PFS18) assessed by BICR according to RECIST 1.1. [ Time Frame: at 18 months from participants' randomisation. ]
To further assess the efficacy of durvalumab compared with placebo in terms of PFS18

Proportion of patients at time to death or distant metastasis (TTDM) assessed by BICR according to RECIST 1.1 in randomised patients [ Time Frame: date of randomisation until the first date of distant metastasis or death in the absence of distant metastasis, assessed up to 65months ]
To further assess the efficacy of durvalumab compared with placebo in terms of TTDM.

Peak Plasma Concentration (Cmax) in randomised patients [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
To assess the PK of durvalumab

Trough Concentration (Ctrough) in randomised patients [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
To assess the PK of durvalumab

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: from randomisation until 3 months after treatment discontinuation. ]
All AE data will be listed and the treatment-emergence status will be flagged in the listing.

Detection of ADA neutralising antibodies titres for all randomised patients [ Time Frame: at scheduled visits from randomisation to 6months after treatment discontinuation. ]
To investigate the immunogenicity of durvalumab

IHC analysis of tumoural PD-L1 expression and spatial distribution within the tumour microenvironment relative to efficacy outcome OS [ Time Frame: from date of randomisation until the date of death from any cause, whichever came first, assessed up to 65months ]
To investigate the relationship between a patient's baseline tumour PD-L1 expression and OS with durvalumab compared with placebo

IHC analysis of tumoural PD-L1 expression and spatial distribution within the tumour microenvironment relative to efficacy outcome PFS [ Time Frame: from date of randomisation until disease progression, assessed up to 29months ]
To investigate the relationship between a patient's baseline tumour PD-L1 expression and PFS with durvalumab compared with placebo

IHC analysis of tumoural PD-L1 expression and spatial distribution within the tumour microenvironment relative to efficacy outcome ORR [ Time Frame: from date of randomisation until progression, or the last evaluable assessment in the absence of progression, assessed up to 29months ]
To investigate the relationship between a patient's baseline tumour PD-L1 expression and ORR with durvalumab compared with placebo

Number of participants with abnormal findings with physical examination [ Time Frame: At scheduled visits from screening to 30days after treatment discontinuation ]
To assess physical examination as variable of safety and tolerability of durvalumab in participants

vital sign (blood pressure [BP]) [ Time Frame: change from baseline up to follow up/early termination visits (30days after treatment discontinuation) ]
To assess blood pressure as variable of safety and tolerability of durvalumab in participants.

vital sign (pulse rate) [ Time Frame: change from baseline up to follow up/early termination visits (30days after treatment discontinuation) ]
To assess pulse rate as variable of safety and tolerability of durvalumab in participants.

vital sign (temperature) [ Time Frame: change from baseline up to follow up/early termination visits (30days after treatment discontinuation) ]
To assess temperature as variable of safety and tolerability of durvalumab in participants.

vital sign (respiration rate) [ Time Frame: change from baseline up to follow up/early termination visits (30days after treatment discontinuation) ]
To assess respiration rate as variable of safety and tolerability of durvalumab in participants.

vital sign (12-lead electrocardiogram) [ Time Frame: change from baseline up to follow up/early termination visits (30days after treatment discontinuation) ]
To assess 12-lead electrocardiogram as variable of safety and tolerability of durvalumab in participants.

Change in Albumin (g/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for Albumin recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in Alkaline phosphatase (U/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for Alkaline phosphatase recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in Alanine aminotransferase (U/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for Alanine aminotransferase recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in Aspartate aminotransferase (U/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for Aspartate aminotrasnferase recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in Amylase (U/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for Amylase recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in Bicarbonate (mmol/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for Bicarbonate recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in Calcium (mmol/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for Calcium recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in Chloride (mmol/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for Chloride recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in Creatinine (μmol/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for Creatinine recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in Gamma glutamyltransferase (U/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for Gamma glutamyltransferase recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in Glucose (mmol/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for Glucose recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in Lactate dehydrogenase (U/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for Lactate dehydrogenase recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in Lipase (U/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for Lipase recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in Magnesium (mmol/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for Magnesium recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in Potassium (mmol/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for Potassium recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in Sodium (mmol/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for Sodium recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in Total bilirubin (μmol/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for total bilirubin recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in total protein (g/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for protein recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in TSH (mIU/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for TSH recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in T3 free (reflex) (mIU/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for free T3 recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in T4 free (reflex) (mIU/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for free T4 recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in Urea or blood urea nitrogen, depending on the local practice (mmol/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for urea nitrogen recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in Uric acid (mmol/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for uric acid recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in absolute neutrophil count (/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for absolute neutrophil recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in absolute lymphocyte count (/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for absolute lymphocyte recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in haemoglobin (g/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for haemoglobin recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in platelet count (/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for platelet count recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in total white blood cell count (/L) [ Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation. ]
Data for WBC count recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in activated partial thromboplastin time [ Time Frame: at screening and as clinical needed before treatment disocontinuation, assessed up to 65months ]
Data for active partial thromboplastin recorded in the eCRF will be listed and summarized by treatment group and visit.

Change in international normalised ratio [ Time Frame: at screening and as clinical needed before treatment disocontinuation, assessed up to 65months ]
Data for international normalised ratio recorded in the eCRF will be listed and summarized by treatment group and visit.

Urinalysis: Change in bilirubin (μmol/L) [ Time Frame: at screening and as clinical needed before treatment disocontinuation, assessed up to 65months ]
Data for bilirubin recorded in the eCRF will be listed and summarized by treatment group and visit.

Urinalysis: Change in blood [ Time Frame: at screening and as clinical needed before treatment disocontinuation, assessed up to 65months ]
Data for blood testing recorded in the eCRF will be listed and summarized by treatment group and visit.

Urinalysis: Change in color and apprearance [ Time Frame: at screening and as clinical needed before treatment disocontinuation, assessed up to 65months ]
color and apprearance of urine recorded in the eCRF will be listed and summarized by treatment group and visit.

Urinalysis: Change in ketones (mmol/L) [ Time Frame: at screening and as clinical needed before treatment disocontinuation, assessed up to 65months ]
Data for ketones in urine recorded in the eCRF will be listed and summarized by treatment group and visit.

Urinalysis: Change in pH [ Time Frame: at screening and as clinical needed before treatment disocontinuation, assessed up to 65months ]
Data for urine pH recorded in the eCRF will be listed and summarized by treatment group and visit.

Urinalysis: Change in protein (g/L) [ Time Frame: at screening and as clinical needed before treatment disocontinuation, assessed up to 65months ]
Data for protein recorded in the eCRF will be listed and summarized by treatment group and visit.

Urinalysis: Change in specific gravity [ Time Frame: at screening and as clinical needed before treatment disocontinuation, assessed up to 65months ]
Data for gravity recorded in the eCRF will be listed and summarized by treatment group and visit.

Inclution Criteria

Inclusion criteria
Patients are eligible to be included in the study only if all of the following inclusion criteria and
none of the exclusion criteria apply:
Informed consent
1. Capability to give signed informed consent that includes compliance with the
requirements and restrictions listed in the informed consent form (ICF) and in this
protocol
2. Provision of signed and dated written ICF prior to any mandatory study-specific
procedures, sampling, and analyses
The ICF process is described in Appendix A 3.
Age
3. Age ≥18 years at the time of Screening
Type of patient and disease characteristics
4. Histologically or cytologically documented NSCLC and present with locally
advanced, unresectable (Stage III) disease (according to Version 8 of the (IASLC
Staging Manual in Thoracic Oncology]). Positron emission tomography/CT, MRI of
the brain, and endobronchial ultrasound with biopsy are highly encouraged at
diagnosis.
5. Receipt of concurrent or sequential chemoradiation therapy, which must be completed
within 1 to 28 days prior to first dose of IP in the study.
 For cCRT, patients must have received at least 2 cycles of platinum-based
chemotherapy concurrent with radiation therapy. The last dose of chemotherapy
must be prior to, or concurrent with, the final dose of radiation. Consolidation
chemotherapy after radiation is not permitted, but no more than 2 cycles of
induction chemotherapy prior to cCRT is acceptable.
 For sCRT, patients must have received at least 2 cycles of platinum-based
chemotherapy before radiation therapy. The interval between administration of
the last dose of chemotherapy regimen and start of RT must be no more than
6 weeks. Consolidation chemotherapy after radiation is not permitted.
(i) Note: If a patient receives only 1 cycle of platinum-based chemotherapy
concurrent with radiation treatment, this patient will be eligible for the
study to participate in the sCRT stratum.
 The platinum-based chemotherapy regimen must contain cisplatin or carboplatin
and 1 of the following agents: etoposide, vinblastine, vinorelbine, a taxane
(paclitaxel or docetaxel), or pemetrexed, according to the local SoC regimens.
(Gemcitabine is not included.)
 Patients must have received a total dose of radiation of 60 Gy ±10% (54 to 66 Gy)
to be randomised as part of the chemoradiation therapy. Study sites are
encouraged to adhere to the following mean organ radiation dosing:
(i) Mean lung dose must be <20 Gy, and/or V20 must be <35%
(ii) Mean oesophagus dose must be <34 Gy
(iii) Heart V45 must be <35%, or V30 must be <30%
 Study sites should be aware of the recent RTOG 0617 Trial data demonstrating
that doses higher than 60 Gy may be associated with greater toxicity and worse
efficacy.
6. No progression following definitive, platinum-based, concurrent or sequential
chemoradiation therapy
7. Tumor PD-L1 status, with the Ventana SP263 PD-L1 IHC assay determined by a
reference laboratory, must be known prior to randomization. Patient with unknown
PD-L1 status is not eligible for the study. “Unknown” refers to (1) insufficient sample
which is not able to be analyzed, or (2) sample could be analyzed but results not
interpretable.
8. Documented EGFR and ALK status (locally or centrally) at Screening. If the local
laboratory will perform the test, a well-validated, local regulatory-approved kit must
be used.
 EGFR and ALK status must be available prior to randomisation. After
approximately 15% EGFR or ALK mutant patients have been randomised, the
incoming patients with EGFR or ALK mutation will not be enrolled.
9. Tumour sample requirements are as follows: Provision of a tumour tissue sample
(newly acquired sample 3 months old is preferred, but an archived sample 6 months
old is acceptable) in a quantity sufficient to allow for analysis (refer to Section 8.8.1
and the Laboratory Manual for details). Study subject should not have received any
intervening systemic therapy other than chemoradiotherapy for Stage III disease as
described above.
10. World Health Organization (WHO) PS of 0 or 1 at enrolment
11. No prior exposure to any anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2
antibodies, excluding therapeutic anticancer vaccines
12. Adequate organ and marrow function as defined below. Absolute neutrophil count,
platelet count, and haemoglobin criteria cannot be met with transfusion or growth
factor support administered within 14 days before randomisation.
 Haemoglobin ≥9 g/L
 Absolute neutrophil count >1.5 × 109
/L (1500 per mm3
)
 Platelet count >100 × 109
/L (100000 per mm3
)
 Serum bilirubin ≤1.5× the upper limit of normal (ULN). This will not apply to
patients with confirmed Gilbert’s syndrome (persistent or recurrent
hyperbilirubinemia that is predominantly unconjugated in the absence of evidence
of haemolysis or hepatic pathology), who will be allowed in consultation with
their primary physician.
 Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×
ULN
 Serum creatinine clearance (CL) >40 mL/min by the Cockcroft-Gault formula
(Cockcroft and Gault 1976) or by 24-hour urine collection for determination of
creatinine CL
Males
Creatinine CL = Weight (kg) × (140 - Age)
(mL/min) 72 × serum creatinine (mg/dL)
Females:
Creatinine CL = Weight (kg) × (140 - Age) × 0.85
(mL/min) 72 × serum creatinine (mg/dL)
13. Life expectancy of at least 12 weeks at Day 1
14. WT >30 kg

Exclusion Criteria

Exclusion criteria
Patients should not enter the study if any of the following exclusion criteria are fulfilled:
Medical conditions
1. History of allogeneic organ transplantation
2. 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:
 Patients with vitiligo or alopecia
 Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on
hormone replacement
 Any chronic skin condition that does not require systemic therapy
 Patients without active disease in the last 5 years may be included but only after
consultation with the Study Physician
 Patients with celiac disease controlled by diet alone
3. Uncontrolled intercurrent illness, including but not limited to, ongoing or active
infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease,
serious chronic gastrointestinal 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
4. 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 investigation product (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
5. History of active primary immunodeficiency
6. Active infection including tuberculosis (clinical evaluation that includes clinical
history, physical examination and radiographic findings, and tuberculosis testing in
line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface
antigen [HBsAg] result), hepatitis C (HCV), or human immunodeficiency virus
(positive human immunodeficiency virus [HIV] 1/2 antibodies). Patients with a past
or resolved HBV infection (defined as the presence of hepatitis B core antibody and
absence of HBsAg) are eligible. Patients positive for HCV antibody are eligible only
if polymerase chain reaction is negative for HCV RNA.
7. Mixed small cell and NSCLC histology
8. Any unresolved toxicity National Cancer Institute (NCI) Common Terminology
Criteria for Adverse Events (CTCAE) Grade ≥2 from the prior chemoradiation
therapy. Patients with irreversible toxicity that is not reasonably expected to be
exacerbated by study treatment may be included (eg, hearing loss) after consultation
with the AstraZeneca Study Physician.
9. Patients with Grade ≥2 pneumonitis from prior chemoradiation therapy
10. Known allergy or hypersensitivity to any of the study drugs or any of the study drug
excipients
Prior/concomitant therapy
11. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for
cancer treatment other than those under investigation in this study
12. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up
to 30 days after the last dose of IP.
13. Major surgical procedure (as defined by the Investigator) within 28 days prior to the
first dose of IP. Note: Local surgery of isolated lesions for palliative intent and
placement of vascular access are acceptable.
14. Current or prior use of immunosuppressive medication within 14 days before the first
dose of durvalumab. The following are exceptions to this criterion:
 Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular
injection)
 Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of
prednisone or its equivalent
 Steroids as premedication for hypersensitivity reactions (eg, CT scan
premedication)
 Systemic steroid administration required as prophylaxis against or to manage
toxicities arising from chemotherapy and/or radiotherapy delivered as part of the
chemoradiation therapy for locally advanced NSCLC
Prior/concurrent clinical study experience
15. Participation in another clinical study with an IP administered in the last 4 weeks prior
to randomization.
16. Previous IP assignment in the present study
17. Concurrent enrolment in another clinical study, unless it is an observational
(non-interventional) clinical study or during the Follow-up Period of an interventional
study
18. Prior randomisation or treatment in a previous durvalumab ± tremelimumab clinical
study regardless of treatment arm assignment
Other exclusions
19. Female patients who are pregnant or breastfeeding or male or female patients of
reproductive potential who are not willing to employ effective birth control from
Screening to 90 days after the last dose of durvalumab monotherapy
20. Judgment by the Investigator that the patient should not participate in the study if the
patient is unlikely to comply with study procedures, restrictions, and requirements

The Estimated Number of Participants

  • Taiwan

    34 participants

  • Global

    360 participants

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