Kliinilise uuringu otsus nr RKU-4/70

Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477

16.09.2024 nr RKU-4/70

OTSUS

Ravimi kliinilise uuringu loa andmiseks Euroopa Parlamendi ja nõukogu määruse (EL) nr

536/2014 (määrus (EL) 536/2014) alusel

Uuringu sponsor ETOP IBCSG Partners Foundation esitas 21.05.2024 Ravimiametile taotluse

ravimi kliinilise uuringu teostamiseks määruse (EL) 536/2014 artikli 5 (1) ja ravimiseaduse

(RavS) § 991 lõikes 1 sätestatud tingimustel.

Tuginedes määruse (EL) 536/2014 artiklile 8, hindamisaruande I ja II osaga hõlmatud aspekte

hinnates, otsustab Ravimiamet ravimiseaduse § 996 lg 1 punkti 2 ja lõike 3 alusel

anda uuringu sponsorile ETOP IBCSG Partners Foundation loa ravimi kliinilise uuringu

läbiviimiseks vastavalt esitatud uuringuplaanile nr ETOP25-23 ADOPT-lung järgmistel

tingimustel:

uuringuplaani number: ETOP25-23 ADOPT-lung (versioon 1.1 kuupäevaga 15. august

2024)

uuringu referentsnumber: 24-013

uuringu nimetus: „ETOP 25-23 ADOPT-lung: An international, multicentre, open-label

randomised phase III trial to evaluate the benefit of adding adjuvant durvalumab after

neoadjuvant chemotherapy plus durvalumab in patients with stage IIB-IIIB (N2) resectable

NSCLC“

uuringu sponsor: ETOP IBCSG Partners Foundation

uuritavate arv Eestis: 30

uuringu algus: oktoober 2024

vastutavad uurijad ja uuringukeskused:

- Dr Kersti Oselin, sihtasutus Põhja-Eesti Regionaalhaigla, J. Sütiste tee 19, 13419

Tallinn, Eesti

Barbara Ruepp

ETOP IBCSG Partners Foundation

Effingerstrasse 33

3008 Bern

ŠVEITS

2 (2)

Vaide käesolevale otsusele saab esitada Ravimiametile 30 päeva jooksul arvates otsuse

teatavaks tegemisest vastavalt haldusmenetluse seaduse § 71 lõikele 1. Kui otsuse saaja soovib

otsust vaidlustada halduskohtus, võib ta vastavalt halduskohtumenetluse seadustiku § 7 lõikele

1 ja § 46 lõikele 1 esitada kaebuse otsuse peale Tartu Halduskohtule 30 päeva jooksul otsuse

teatavaks tegemisest arvates.

Lugupidamisega

(allkirjastatud digitaalselt)

Katrin Kiisk

Peadirektor

Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477

16.09.2024 nr RKU-4/70

DECISION

to grant authorisation for clinical trial on the basis of Regulation (EU) No 536/2014 of the

European Parliament and of the council

State Agency of Medicines has received the application from sponsor ETOP IBCSG Partners

Foundation on 21.05.2024 to conduct a clinical trial under the conditions stipulated in

Regulation (EU) No 536/2014 art 5 (1) and § 991 (1) of Estonian Medicinal Products Act

(MPA).

Based on art 8 of Regulation (EU) No 536/2014, considering the aspects covered by Part I and

Part II of the assessment report, on the basis of § 996 section 1 p 2 and (3) of Medicinal Product

Act

State Agency of Medicines has decided to give the approval to conduct the clinical study

protocol no ETOP25-23 ADOPT-lung under the following conditions:

protocol no: ETOP25-23 ADOPT-lung (Version 1.1, dated August 15, 2024)

full title of the trial: ETOP 25-23 ADOPT-lung: An international, multicentre, open-label

randomised phase III trial to evaluate the benefit of adding adjuvant durvalumab after

neoadjuvant chemotherapy plus durvalumab in patients with stage IIB-IIIB (N2) resectable

NSCLC

sponsor of the trial: ETOP IBCSG Partners Foundation

number of subjects in Estonia: 30

starting date: October 2024

principal investigators and study locations:

- Dr Kersti Oselin, North Estonia Medical Centre Foundation, J. Sütiste tee 19, 13419

Tallinn, Estonia

The addressee may file a challenge with State Agency of Medicines within 30 days as of the

day when the addressee became or should have become aware of the decision as prescribed in

Code of Administrative Procedure § 71(1). If the addressee wishes to have the decision to

Barbara Ruepp

ETOP IBCSG Partners Foundation

Effingerstrasse 33

3008 Bern

SWITZERLAND

2 (2)

annulled by the administrative court, he or she may submit a complaint to the Tartu

Administrative Court as prescribed in § 7(1) and § 46(1) of the Code of Administrative Court

Procedure within 30 days after the date on which the decision was notified to the applicant.

(digitally signed)

Katrin Kiisk

Director General