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Clinical Trials List

Protocol NumberD9078C00001
NCT Number(ClinicalTrials.gov Identfier)NCT05221840
Active

2022-01-01 - 2031-02-27

Phase III

Recruiting8

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy

  • Trial Applicant

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 彭忠衎 Division of Thoracic Medicine
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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 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

0 Recruiting

Principal Investigator 柯政昌 Division of Thoracic Medicine
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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 Gee-chen Chang Division of Thoracic Medicine
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Ta Yang Division of Thoracic Medicine
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-Small Cell Lung Cancer

Objectives

assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.

Test Drug

Durvalumab
Oleclumab
Monalizumab

Active Ingredient

MEDI4736
MEDI9447
IPH2201

Dosage Form

Injection
Injection
Injection

Dosage

50 mg/ml
100 mg/ml
50 mg/ml

Endpoints

PFS is defined as time from randomization until
progression per RECIST 1.1 as assessed by BICR,
or death due to any cause.
 PFS measured by HR.
 The comparison will include all randomised
participants, as randomised, regardless of
whether the participant withdraws from
randomised therapy, receives another
anticancer therapy or clinically progresses
prior to RECIST 1.1 progression. However, if
the participant progresses or dies immediately
after two or more consecutive missed visits,
the participant will be censored at the time of
the latest evaluable assessment prior to the
two missed visits.

Inclution Criteria

Part I Screening:
In order to expedite tissue analysis, part I screening procedures may begin before cCRT has
been completed.
Participants are eligible to be included in the study only if all of the following criteria apply:
Age
1. Participant must be ≥ 18 years at the time of screening. For patients aged 18-19 years and
enrolled in Japan, a written informed consent should be obtained from the participant and
his or her legally acceptable representative (until the Civil Code is amended for Japan for
the legal age of adulthood to be ≥ 18 years on April 1st, 2022).
Type of Participant and Disease Characteristics
2. Participants must have histologically- or cytologically-documented NSCLC and have
been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
(according to Version 8 of the International Association for the Study of Lung Cancer
Staging Manual in Thoracic Oncology [IASLC Staging Manual in Thoracic Oncology]).
Initial staging procedures performed prior to initiation of any component of definitive
treatment should include:
- Positron Emission Tomography – Computed Tomography (PET-CT) scan. Full-body
scan is preferred, but a scan from at least the base of skull to mid-thigh is permissible.
The scan must have been performed up to 42 days prior to the first dose of concurrent
chemoradiotherapy (CRT) or induction chemotherapy cycles, if utilized.
- Brain imaging with MRI (preferred) or high quality CT with IV contrast is strongly
encouraged during initial staging.
- Except for overt cT4 disease, biopsy strongly preferred to prove nodal status N2 or N3
via endobronchial ultrasound, mediastinoscopy, or thoracoscopy.
3. Tumour sample requirements as follows: Provision of a tumour tissue sample (obtained ≤
3 months prior to Screening is preferred; ≤ 6 months prior to Screening is acceptable).
The tumour sample must be obtained prior to CRT; irradiated samples are not acceptable
(refer to Section 8.6.1 and the Laboratory Manual for details). An FFPE block sufficient
for sectioning 20 slides (5 micron thickness) is preferred. If FFPE blocks cannot be
submitted, then a set of newly-cut, unstained slides that enables necessary testing may be
provided.
4. Documented tumour PD-L1 status as determined by a central laboratory testing using the
Ventana SP263 PD-L1 IHC assay prior to randomization. Patients with unknown PD-L1
status are not eligible for study.
5. Documented EGFR and ALK wild-type status. If a local laboratory performs the test, a
well-validated, locally-approved test must be used. If local EGFR and ALK results are not available at time of screening, the assays will be performed in the central laboratory.
Participants with sensitizing EGFR mutations (e.g., exon 19 deletion or exon 21 L858R,
exon 21 L861Q, exon 18 G719X, or exon 20 insertion or S768I mutation) or ALK
rearrangements are excluded from the study.
6. Tumours harbouring mutations in any of the following genes, if known, as determined by
existing local test results: ROS1, RET, MET, BRAF, NTRK1, NTRK2 and ERBB2 are
excluded.
Informed Consent
7. Capable of giving signed informed consent for tumour sample collection that includes
compliance with the requirements and restrictions listed in the pre-screening informed
consent form (part I screening ICF) as described in Appendix A, which includes
compliance with the requirements and restrictions listed in the ICF and this protocol.
8. Provision of signed and dated written part I screening ICF prior to any mandatory studyspecific procedures and analyses.
Part II Screening
Participants may enter part II screening even if the results of the Part I screening procedures
are still pending.
Participants are eligible to be randomised to the study only if all of the following Part II
inclusion criteria and none of the exclusion criteria apply:
Type of Participant and Disease Characteristics
1 Patients must not have progressed following definitive, platinum-based, cCRT as
demonstrated by the following imaging studies performed after completion of CRT:
(a) Screening baseline RECIST 1.1 imaging of chest and abdomen by CT (preferred) or
MRI (see schedule of assessments Table 1)
(b) Brain MRI (preferred) or high-quality CT with IV contrast (See schedule of
assessments Table 1).
2 Participants must have received at least 2 cycles of platinum-based chemotherapy
concurrent with radiation therapy, which must be completed within 1 to 28 days prior to
first dose of investigational product in the study (one chemotherapy cycle is defined as 21
or as 28 days). Sites are strongly encouraged to complete screening within the first 14
days of the 28-day screening period.
3 The platinum-based chemotherapy regimen must be cisplatin or carboplatin-based and
contain one of the following agents: etoposide, vinblastine, vinorelbine, a taxane
(paclitaxel or docetaxel), or pemetrexed, according to the local standard of care regimens.
Gemcitabine is not permitted.
4 The last dose of chemotherapy must be administered prior to, or concurrently with, the
final dose of radiation. Consolidation chemotherapy after radiation is not permitted. Up to
2 cycles of induction chemotherapy prior to cCRT is permitted.
5 Where possible, chemotherapy regimens should be given according to National
Comprehensive Cancer Network (NCCN) Guidelines or European Society for Medical
Oncology (ESMO) Guidelines.
6 Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy)
as part of the chemoradiation therapy, to be randomised. Radiation therapy should be
administered by intensity modulated RT (preferred) or 3D-conforming technique. Sites
are encouraged to adhere to the following organ dosimetric specifications:
- Mean lung dose must be <20 Gy and/or V20 must be <35%
- Mean eosophagus dose must be <34 Gy
- Heart V45 <35% or V30 <50%.
7 Minimum life expectancy of 12 weeks at randomization
8 WHO performance status of 0 or 1 at randomization
9 Adequate organ and marrow function as defined below:
- Absolute neutrophil count > 1.5 x 109
/L (1500 per mm3
)
- Platelets > 75 x 109
/L (75000 per mm3
)
- Haemoglobin ≥ 9.0 g/dL (5.59 mmol/L)
- Serum creatinine CL >40 mL/min by the Cockcroft-Gault formula
or by 24-hour urine collection for determination of creatinine clearance:
Males:
Creatinine CL
(mL/min)
= Weight (kg) x (140 – Age)
72 x serum creatinine (mg/dL)
Females:
Creatinine CL
(mL/min)
= Weight (kg) x (140 – Age) x 0.85
72 x serum creatinine (mg/dL)
- Serum bilirubin ≤1.5 x upper limit of normal (ULN) or < 3 x ULN in the presence of
documented Gilbert’s syndrome (unconjugated hyperbilirubinemia).
- AST and ALT ≤2.5 x ULN.
Weight
10 Minimum body weight ≥ 40kg at enrolment and randomization.
Reproduction
11 Contraceptive use by men or women should be consistent with local regulations regarding
the methods of contraception for those participating in clinical studies.
12 Negative pregnancy test (serum) for women of childbearing potential.
13 Female participants must be 1 year post-menopausal, surgically sterile, or using one
highly effective form of birth control (a highly effective method of contraception is
defined as one that can achieve a failure rate of less than 1% per year when used
consistently and correctly.) Women of childbearing potential must agree to use one highly
effective method of birth control. They should have been stable on their chosen method of
birth control for a minimum of 3 months before entering the study to 150 days after the
last dose (see Appendix G for complete list of highly effective birth control methods).
Non-sterilised male partners of a woman of childbearing potential must use a male
condom plus spermicide (condom alone in countries where spermicides are not approved)
throughout this period.
14 Male participants who intend to be sexually active with a female partner of childbearing
potential must be surgically sterile or using an acceptable method of contraception (see
Appendix G) from the time of screening throughout the total duration of the study and the
drug washout period (150 days after the last dose of study intervention) to prevent
pregnancy in a partner. Male participants must not donate or bank sperm during this same
time period.
Informed Consent
15 Capable of giving signed informed consent as described in Appendix A, which includes
compliance with the requirements and restrictions listed in the IFC and this protocol.
16 For optional genomic initiative participation only: Provision of signed and dated written
Optional Genetic Research Information informed consent prior to collection of sample for
optional genetic research that supports Genomic Initiative. If a patient declines to
participate in the genetics research, there will be no penalty or loss of benefit to the
patient. A patient who declines genetics research participation will not be excluded from
any other aspect of the main study.

Exclusion Criteria

Medical Conditions
1 As judged by the investigator, any evidence of diseases (such as severe or uncontrolled
systemic diseases, including uncontrolled hypertension, active bleeding diseases, active
infection, active interstitial lung disease/pneumonitis, serious chronic gastrointestinal
conditions associated with diarrhoea, psychiatric illness/social situations) which, in the
investigator’s opinion, makes it undesirable for the participant to participate in the study
or that would jeopardise compliance with the protocol
2 History of another primary malignancy except for malignancy treated with curative intent
with no known active disease > 5 years before the first dose of study intervention and of
low potential risk for recurrence, basal cell carcinoma of the skin, squamous cell carcinoma of the skin or lentigo maligna that has undergone potentially curative therapy,
adequately treated carcinoma in situ or Ta tumours treated with curative intent and
without evidence of disease.
3 Mixed small cell and non-small cell lung cancer histology.
4 Participants who have had disease considered for surgical treatment as part of their care
plan, such as Pancoast or superior sulcus tumours
5 Participants with T4 lesions that invade major vascular structures such as pulmonary
artery or cardiac tissues are not eligible.
6 Participants who receive sequential (not inclusive of induction) chemoradiation therapy
for locally advanced (Stage III) unresectable NSCLC.
7 Participants with locally advanced (Stage III) unresectable NSCLC who have progressed
during platinum-based cCRT.
8 Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy
(excluding alopecia). Participants with irreversible toxicity that is not reasonably expected
to be exacerbated by study intervention may be included (eg, hearing loss) after
consultation with the AstraZeneca study clinical lead.
9 Participants with ≥grade 2 pneumonitis from prior chemoradiation therapy.
10 Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous
immunotherapy agent, or any unresolved irAE >Grade 1.
11 History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, ILD, pleural
effusion, or pulmonary fibrosis diagnosed in the past 6 months prior to randomization.
12 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, granulomatosis
with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis,
autoimmune pneumonitis and autoimmune myocarditis, etc). The following are
exceptions to this criterion:
 Participants with vitiligo or alopecia.
 Participants with hypothyroidism (eg, following Hashimoto syndrome) stable on
hormone replacement.
 Any chronic skin condition that does not require systemic therapy.
 Participants without active disease in the last 5 years may be included but only after
consultation with the study clinical lead.
 Participants with coeliac disease controlled by diet alone.
13 Active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus
(HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening.
Participants with a past or resolved HBV infection (defined as the presence of antiHBc
and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible
only if polymerase chain reaction is negative for HCV RNA
14 Tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies)
or known to have active tuberculosis infection (clinical evaluation that may include
clinical history, physical examination and radiographic findings, or tuberculosis testing in
line with local practice).
15 Investigator judgment of 1 or more of the following:
 Mean resting corrected QT interval > 470 ms, obtained from triplicate ECGs performed
at screening.
 History of QT prolongation associated with other medications that required
discontinuation of that medication, or any current concomitant medication known to
prolong the QT interval and cause Torsades de Pointes (TdP).
 Congenital long QT syndrome, family history of long QT syndrome, or unexplained
sudden cardiac death under 40 years of age in first-degree relatives.
16 History of symptomatic congestive heart failure, unstable angina pectoris, uncontrolled
cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy,
ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3),
symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic
sustained ventricular tachycardia. Participants with atrial fibrillation controlled by
medication or arrhythmias controlled by pacemakers may be permitted upon discussion
with the study clinical lead.
17 Subjects with a history of myocardial infarction, transient ischemic attack, stroke, or
pulmonary embolism diagnosed in the past 6 months or venous thrombosis diagnosed in
the past 3 months prior to the scheduled first dose of study treatment
18 History of primary immunodeficiency
19 Prior allogeneic bone marrow transplant or stem cell/solid organ transplant
20 History of leptomeningeal carcinomatosis
21 Severe infection within 4 weeks prior to initiation of study treatment
Prior / Concomitant Therapy
22 Participants who are expected to require any other form of antineoplastic therapy while
participating in the trial are excluded.
23 Receipt of prior or current cancer treatment for NSCLC, including but not limited to,
radiation therapy, investigational agents, chemotherapy, and mAbs. Prior surgical
resection of metachronous NSCLC (ie, Stage I or II) is permitted.
24 Prior exposure to immune-mediated therapy including, but not limited to, other anti
CTLA-4, anti-PD-1, anti-PD-L1, antiPD-L2 antibodies, anti-CD73 antibodies, and anti
NKG2A antibodies, excluding therapeutic anticancer vaccines.
25 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 or as an anti-emetic (eg, CT
scan premedication).
26 Receipt of live attenuated vaccination within 30 days prior the first dose of study
intervention (see Appendix I 2)
27 Any concurrent anticancer treatment. Concurrent use of hormonal therapy for non-cancerrelated conditions (eg, hormone replacement therapy) is allowed
28 Major surgical procedure or significant traumatic injury within 4 weeks of the first dose
of study intervention or an anticipated need for major surgery during the study.
Prior/Concurrent Clinical Study Experience
29 Previous randomization in the present study or a previous durvalumab, monalizumab, or
oleclumab clinical study regardless of treatment arm assignment.
30 Concurrent participation in another clinical study, unless it is an observational
(non-interventional) clinical study, or the follow-up period of an interventional study
31 Participation in another clinical study with a study intervention during the last 3 months
prior to randomization or concurrent enrolment in another clinical study, unless it is and
observational, non-interventional clinical study during the follow-up period of an
interventional study
32 Receipt of any immunotherapy, or investigational drug within 4 weeks prior to the first
dose of study intervention; and in the case of monoclonal antibodies 6 weeks prior to the
first dose of study intervention.
33 Participants with a known allergy or hypersensitivity to durvalumab, oleclumab or
monalizumab, or any excipients of the products
Other Exclusions
34 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
staff and/or staff at the study site).
35 Judgment by the investigator that the participant should not participate in the study if the
participant is unlikely to comply with study procedures, restrictions, and requirements.
36 Female participants who are pregnant or breastfeeding or male or female participants of
reproductive potential who are not willing to employ effective birth control from
screening to 150 days after the last dose of study intervention.

The Estimated Number of Participants

  • Taiwan

    21 participants

  • Global

    999 participants

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