Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
320
Countries
2
Sites
4
Patients with Locally Advanced, Unresectable Non-small Cell Lung Cancer (Stage III)
To assess the efficacy of durvalumab + standard of care (SoC) chemoradiation therapy (CRT) compared with placebo + SoC CRT in terms of Progression Free Survival (PFS).
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 Jun 2018 → 9 Mar 2026
- Decision date (initial)
- 2024-11-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AstraZeneca AB
External identifiers
- EU CT number
- 2024-515321-29-00
- EudraCT number
- 2017-004397-34
- ClinicalTrials.gov
- NCT03519971
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Efficacy
To assess the efficacy of durvalumab + standard of care (SoC) chemoradiation therapy (CRT) compared with placebo + SoC CRT in terms of Progression Free Survival (PFS).
Secondary objectives 1
- Assess the efficacy of durvalumab+SoC CRT compared with placebo+SoC CRT in terms of : -Objective response rate (ORR) -Overall Survival (OS) -Overall Survival at 24months (OS24) -Rate of Complete Response (CR) -Duration of Response (DoR) -Disease Control Rate (DCR) -Time from randomization to second progression (PFS2) -Time to death or distant metastasis (TTDM) -Pharmacokinetics (PK) of Durvalumab when in combination with CRT. -Immunogenicity of Durvalumab +/- in combination with CRT -Effect of Durvalumab+ SoC CRT compared with placebo on subjects -Disease-related symptoms and Health related quality of life (HRQoL) -Safety Objective using EORTC QLQ-C30 v3 and QLQ-LC
Conditions and MedDRA coding
Patients with Locally Advanced, Unresectable Non-small Cell Lung Cancer (Stage III)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment period Drug dosing period
|
Randomised Controlled | Double | [{"id":149506,"code":4,"name":"Analyst"},{"id":149504,"code":2,"name":"Investigator"},{"id":149503,"code":3,"name":"Monitor"},{"id":149507,"code":1,"name":"Subject"},{"id":149505,"code":5,"name":"Carer"}] | Arm 1: Durvalumab+SoC CRT Arm 2: Placebo+SoC CRT |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- '- Subjects with histologically- or cytologically-documented NSCLC - Locally advanced or unresectable (Stage III) NSCLC - World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrollment and randomization. - At least one measurable lesion, not previously irradiated - Must have a life expectancy of at least 12 weeks at randomization
Exclusion criteria 1
- '- Receipt of prior or current cancer treatment, including but not limited to, radiation therapy, investigational agents, chemotherapy, Durvalumab and mAbs. - 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. - History of allogeneic organ transplantation - Active or prior documented autoimmune or inflammatory disorders - Uncontrolled intercurrent illness - History of another primary malignancy / leptomeningeal carcinomatosis / active primary immunodeficiency - Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus - Mixed small cell and NSCLC histology. - Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the local labelling - Known allergy or hypersensitivity to any of the IPs or any of the IP excipients. - Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving ≥20 Gy in total (V20) of more than 35% of lung volume. - Patients who have disease considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumors. Patients with T4 lesions that invade major vascular structures such as pulmonary artery or cardiac tissues are also not eligible.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFS using BICR assessments according to RECIST 1.1
Secondary endpoints 2
- OS and OS24 ORR, Rate of CR, DoR, DCR, and TTDM using BICR assessments according to RECIST 1.1 PFS2 as defined by local standard clinical practice Concentration of durvalumab in blood (such as peak and trough concentration, as data allow; sparse sampling) ADA (confirmatory results: positive or negative; titers [ADA neutralizing antibodies will also be assessed])
- Presence of ADA for durvalumab (confirmatory results: positive or negative; titers); EORTC QLQ-C30 and QLQ-LC13: Change in symptoms, functioning, and global health status/QoL Safety objective: to assess the safety and tolerability profile of durvalumab + SoC CRT compared with placebo + SoC CRT
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
SCP134220 · ATC
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg/m2 milligram(s)/square meter
- Max total dose
- 00 mg/m2 milligram(s)/square meter
- Max treatment duration
- 54 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP129816 · ATC
- Active substance
- Paclitaxel
- Substance synonyms
- ONCOGEL, ABI-007, MBT 0206
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg/m2 milligram(s)/sq. meter
- Max total dose
- 00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 54 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP100376572 · ATC
- Active substance
- Etoposide
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg/m2 milligram(s)/sq. meter
- Max total dose
- 00 mg/m2 milligram(s)/square meter
- Max treatment duration
- 54 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01CB01 — ETOPOSIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP10337134 · ATC
- Active substance
- Carboplatin
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 54 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP111841108 · ATC
- Active substance
- Pemetrexed Disodium
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg/m2 milligram(s)/square meter
- Max total dose
- 00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 54 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — PEMETREXED
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IMFINZI 50 mg/mL concentrate for solution for infusion.
PRD6651398 · Product
- Active substance
- Durvalumab
- Substance synonyms
- MEDI4736
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 1500 mg milligram(s)
- Max treatment duration
- 54 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF03 — -
- Marketing authorisation
- EU/1/18/1322/001
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB20722 · Substance
- Active substance
- Saline
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 54 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
SCP139856 · ATC
- Active substance
- Mycophenolate Mofetil
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 54 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA06 — MYCOPHENOLIC ACID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP106366361 · ATC
- Active substance
- Infliximab
- Substance synonyms
- ABP 710, CT-P13, NI-071, PF-06438179, R-TPR-015
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 54 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — INFLIXIMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Sponsor responsibilities
- Article 77 compliance
- AstraZeneca AB
- Contact point sponsor
- AstraZeneca AB
- Article 77 implementation
- AstraZeneca AB
Locations
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ended | 32 | 1 |
| Poland | Ended | 27 | 3 |
| Rest of world
Turkey, Philippines, Brazil, Japan, Thailand, Korea, Republic of, Mexico, Vietnam, Peru, Russian Federation, India
|
— | 261 | — |
Investigational sites
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Pulmonológiai Osztály, Vasvari Pal Utca 2-4, 9024, Gyor
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Oddział Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Nu Med Grupa S.A.
Oddzial Onkologiczny, Ul. Krolewiecka 146, 82-300, Elblag
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Płuc i Klatki Piersiowej, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Hungary | 2018-06-26 | 2024-08-27 | 2018-06-26 | 2019-06-24 | |
| Poland | 2018-07-19 | 2026-02-17 | 2018-07-26 | 2019-06-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 14 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-515321-29-00_redacted | 4 |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | NA |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | NA |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adult PL_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adult Withdrawal Addendum PL | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF pregnant partners PL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF genetic research addendum_HU_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_HU_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partner_HU | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cisplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Etoposide | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Paclitaxel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Pemetrexed | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-27 | Poland | Acceptable 2024-11-18
|
2024-11-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-23 | Poland | Acceptable 2025-11-15
|
2025-11-17 |