A study of MK7684A in Combination with radiation and chemotherapy versus radiation and chemotherapy followed by Durvalumab for patients with Stage III lung cancer that cannot be surgically treated

Start 29 Apr 2022 · End 6 May 2026 · Status Ended · 11 EU/EEA countries · 38 sites · Protocol MK-7684A-006

Overview

Sponsor-declared trial summary

Phase Phase III and Phase IV (Integrated)

Status Ended

Participants planned 209

Countries 11

Sites 38

Non-small cell lung cancer

Per protocol amendment 4, there are no primary or secondary objectives

Key facts

Sponsor: Merck Sharp & Dohme LLC
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 29 Apr 2022 → 6 May 2026
Decision date (initial): 2024-10-07
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: Merck Sharp & Dohme LLC

External identifiers

EU CT number: 2022-502752-31-00
EudraCT number: 2021-005135-23
WHO UTN: U1111-1285-3656

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Pharmacodynamic, Pharmacogenetic, Efficacy, Therapy

Per protocol amendment 4, there are no primary or secondary objectives

Conditions and MedDRA coding

Non-small cell lung cancer

Version	Level	Code	Term	System organ class
21.1	LLT	10029514	Non-small cell lung cancer NOS	10029104

Regulatory references

Scientific advice from competent authorities: European Medicines Agency
Plan to share IPD: Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

Has pathologically (histologically or cytologically) confirmed diagnosis of NSCLC.
Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8
Is determined to have unresectable, Stage III NSCLC as documented by a multidisciplinary tumor board or by the treating physician in consultation with a thoracic surgeon
Has no evidence of metastatic disease, indicating Stage IV NSCLC, in whole-body fluorodeoxyglucose (FDG)-positron emission tomography (PET) or FDG-PET/ computed tomography (CT) and CT or magnetic resonance imaging (MRI) scans of diagnostic quality of chest, abdomen, pelvis and brain
Has measurable disease as defined by RECIST 1.1, with at least 1 lesion being appropriate for selection as a target lesion, as determined by local site investigator/radiology review
Has not received prior treatment (chemotherapy, targeted therapy, or radiotherapy) for their Stage III NSCLC
Has provided tumor tissue sample (tissue biopsy [core, incisional, or excisional])
Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 assessed within 7 days prior to the first administration of study intervention
Has a life expectancy of at least 6 months

Exclusion criteria 17

Has small cell lung cancer (SCLC) or tumors with the presence of small cell elements. Mixed squamous/nonsquamous tumors are eligible
Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer
Has received major surgery (with the exception of replacement of vascular access) within 4 weeks before randomization. If the participant had a major operation, the participant must have recovered adequately from the procedure and/or any complications from the operation before starting study intervention
Is expected to require any other form of antineoplastic therapy, while on study
Has received colony-stimulating factors (e.g., Granulocyte Colony-Stimulating Factor [G-CSF], Granulocyte Macrophage Colony-Stimulating Factor [GM-CSF], or recombinant erythropoietin) within 28 days prior to the first dose of study intervention
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
Has a known additional malignancy that is progressing or has required active treatment within the past 5 year
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV ribonucleic acid [RNA] qualitative is detected) infection
Has had an allogenic tissue/solid organ transplant
Pemetrexed-specific Criteria: Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed
Pemetrexed-specific Criteria: Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Per protocol amendment 4, there are no primary or secondary endpoints

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

MK-7684A

PRD9386962 · Product

Active substance: Pembrolizumab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS INFUSION
Max daily dose: 400 mg milligram(s)
Max total dose: 8000 mg milligram(s)
Max treatment duration: 60 Week(s)
Authorisation status: Not Authorised
MA holder: MERCK & CO. INC.
Paediatric formulation: No
Orphan designation: No

Comparator 2

IMFINZI 50 mg/mL concentrate for solution for infusion.

PRD6651398 · Product

Active substance: Durvalumab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS ADMINISTRATION
Max daily dose: 10 mg/kg milligram(s)/kilogram
Max total dose: 260 mg/kg milligram(s)/kilogram
Max treatment duration: 52 Week(s)
Authorisation status: Authorised
ATC code: L01XC28 — -
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

Durvalumab

SCP31706250 · ATC

Active substance: Durvalumab
Substance synonyms: MEDI4736
Route of administration: INTRAVENOUS INFUSION
Max daily dose: 10 mg/kg milligram(s)/kilogram
Max total dose: 260 mg/kg milligram(s)/kilogram
Max treatment duration: 52 Week(s)
Authorisation status: Authorised
ATC code: L01XC28 — DURVALUMAB
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Auxiliary 7

Carboplatin

SCP28192792 · ATC

Active substance: Carboplatin
Route of administration: INTRAVENOUS INFUSION
Max daily dose: 6 Other
Max total dose: 18 Other
Max treatment duration: 9 Week(s)
Authorisation status: Authorised
ATC code: L01XA02 — CARBOPLATIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

ALIMTA 500 mg powder for concentrate for solution for infusion

PRD2433114 · Product

Active substance: Pemetrexed
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 500 mg/m2 milligram(s)/sq. meter
Max total dose: 1500 mg/m2 milligram(s)/sq. meter
Max treatment duration: 9 Week(s)
Authorisation status: Authorised
ATC code: L01BA04 — -
Marketing authorisation: EU/1/04/290/001
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pemetrexed

SCP60141047 · ATC

Active substance: Pemetrexed
Route of administration: INTRAVENIOUS INFUSION
Max daily dose: 500 mg/m2 milligram(s)/sq. meter
Max total dose: 1500 mg/m2 milligram(s)/sq. meter
Max treatment duration: 9 Week(s)
Authorisation status: Authorised
ATC code: L01BA04 — PEMETREXED
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Paclitaxel

SCP247399 · ATC

Active substance: Paclitaxel
Substance synonyms: ONCOGEL, ABI-007, MBT 0206
Route of administration: INTRAVENOUS USE
Max daily dose: 200 mg/m2 milligram(s)/sq. meter
Max total dose: 470 mg/m2 milligram(s)/square meter
Max treatment duration: 9 Week(s)
Authorisation status: Authorised
ATC code: L01CD01 — PACLITAXEL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Eto-GRY® 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung

PRD3108091 · Product

Active substance: Etoposide
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENIOUS INFUSION
Max daily dose: 50 mg/m2 milligram(s)/sq. meter
Max total dose: 750 mg/m2 milligram(s)/square meter
Max treatment duration: 9 Week(s)
Authorisation status: Authorised
ATC code: L01CB01 — ETOPOSIDE
Marketing authorisation: 45891.00.00
MA holder: TEVA GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Etoposide

SCP6155697 · ATC

Active substance: Etoposide
Route of administration: INTRAVENOUS USE
Max daily dose: 50 mg/m2 milligram(s)/square meter
Max total dose: 750 mg/m2 milligram(s)/sq. meter
Max treatment duration: 9 Week(s)
Authorisation status: Authorised
ATC code: L01CB01 — ETOPOSIDE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cisplatin

SCP26873719 · ATC

Active substance: Cisplatin
Substance synonyms: Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
Route of administration: INTRAVENOUS USE
Max daily dose: 75 mg/m2 milligram(s)/sq. meter
Max total dose: 225 mg/m2 milligram(s)/sq. meter
Max treatment duration: 9 Week(s)
Authorisation status: Authorised
ATC code: L01XA01 — CISPLATIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation: Merck Sharp & Dohme LLC
Address: 126 East Lincoln Avenue
City: Rahway
Postcode: 07065-4607
Country: United States

Scientific contact point

Organisation: Merck Sharp & Dohme LLC
Contact name: Andrew Song

Public contact point

Organisation: Merck Sharp & Dohme LLC
Contact name: Andrew Song

Third parties 9

Organisation	City, country	Duties
Hematogenix Laboratory Services LLC ORG-100040020	Tinley Park, United States	Other
American College Of Radiology Inc. ORG-100047100	Philadelphia, United States	Other
Endpoint And Outcomes Research LLC ORG-100044473	Boston, United States	Interactive response technologies (IRT)
Parexel International Corp. ORG-100007310	Auburndale, United States	Other
PPD Global Central Labs ORG-100046496	Zaventem, Belgium	Other
ICON Medical Imaging ORL-000001154	Blue Bell, United States	Other
Reify Health ORL-000000515	Boston, United States	Other
Clario ORL-000001148	Philadelphia, United States	E-data capture
Greenphire LLC ORG-100041621	King Of Prussia, United States	Other

Locations

11 EU/EEA countries · 38 investigational sites

By country

Country	MS status	Planned subjects	Sites
Austria	Ended	5	1
Croatia	Ended	4	1
Czechia	Ended	8	2
France	Ended	9	3
Germany	Ended	4	4
Greece	Ended	7	7
Italy	Ended	7	7
Poland	Ended	10	1
Portugal	Ended	4	3
Romania	Ended	6	5
Spain	Ended	4	4
Rest of world Turkey, China, Brazil, Ukraine, United States, Australia, Guatemala, Mexico, South Africa, Malaysia, Russian Federation, Philippines, Chile, Israel, Costa Rica, Japan, Dominican Republic, Korea, Republic of	—	141	—

Investigational sites

Austria

1 site · Ended

Stadt Wien Wiener Gesundheitsverbund

Klinik Penzing Abteilung für Atemwegs- und Lungenkrankheiten, Baumgartner Hoehe 1, Penzing, Vienna

Croatia

1 site · Ended

Klinicki bolnicki centar Sestre milosrdnice

Oncology, Vinogradska Cesta 29, Zagreb, Grad Zagreb

Czechia

2 sites · Ended

Masarykuv Onkologicky Ustav

Oncology department, Zluty Kopec 543/7, Stare Brno, Brno-Stred

Fakultni Nemocnice Ostrava

Oncology department, 17. Listopadu 1790/5, Poruba, Ostrava

France

3 sites · Ended

Assistance Publique Hopitaux De Paris

Thoracic Oncology, 27 Rue Du Faubourg Saint Jacques, 75014, Paris

HIA Sainte Anne

Respiratory Department, 2 Boulevard Sainte Anne, Bp 600, Toulon Cedex 9

Clinique Ambroise Pare

Oncology - Radiotherapy, Rue Delbecque, 62660, Beuvry

Germany

4 sites · Ended

Universitaetsklinikum Schleswig-Holstein

Klinik für Innere Medizin II im Karl-Lennert-Krebszentrum, Hämatologie und Onkologie, Arnold-Heller-Strasse 3, Brunswik, Kiel

Klinikum Chemnitz gGmbH

Zentrum für klinische Studien, Flemmingstrasse 2, Altendorf, Chemnitz

LungenClinic Grosshansdorf GmbH

Onkologischer Schwerpunkt, Woehrendamm 80, 22927, Grosshansdorf

Charite Universitaetsmedizin Berlin KöR

Medizinische Klinik mit Schwerpunkt Infektiologie und Pneumologie, Augustenburger Platz 1, Wedding, Berlin

Greece

7 sites · Ended

Metropolitan Hospital

4th Oncology Department, Ethnarchi Makariou 11, 185 47, Pireas

University General Hospital Of Heraklion

Internal Medicine-Oncology Department, Stavrakia And Voutes, 715 00, Heraklion

Henry Dunant Hospital Center

D Oncology Department, 107 Mesogeion Avenue, 115 26, Athens

Alexandra Hospital

Therapeutic Clinic, Oncology-Hematology Unit, Plasma Cell Dysplacia Unit, Vassilissas Sofias Avenue 80, 115 28, Athens

General Oncological Hospital Of Kifissia Agioi Anargyroi

Department of Medical Oncology, Timio Stavrou And 14 Noufaron, 145 64, Kifissia

Thoracic General Hospital Of Athens I Sotiria

3rd Internal Medicine Department-Oncology Unit, Messogion Avenue 152, 115 27, Athens

Athens Medical Center S.A.

Oncology Department, Pylea, Asklipiou 10, Thessaloniki

Italy

7 sites · Ended

Fondazione IRCCS Istituto Nazionale Dei Tumori

SC Oncologia Medica, Via Giacomo Venezian 1, 20133, Milan

IRCCS Istituto Nazionale Tumori Fondazione Pascale

S.C. Oncologia Clinica Sperimentale Toraco-Polmonare, Via Mariano Semmola 52, 80131, Naples

Fondazione IRCCS Policlinico San Matteo

U.O.C. Radioterapia Oncologica, Viale Camillo Golgi 19, 27100, Pavia

Fondazione Policlinico Universitario Campus Bio-Medico

UOC Radioterapia Oncologica, Via Alvaro Del Portillo N 200, 00128, Rome

Ospedale San Raffaele S.r.l.

Dipartimento Oncologia Medica, Via Olgettina 60, 20132, Milan

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

U.O.C Radioterapia, Piazzale Spedali Civili 1, 25123, Brescia

Fondazione IRCCS San Gerardo Dei Tintori

U.O.C.Centro di ricerca di Fase I, Via Giovanni Battista Pergolesi 33, 20900, Monza

Poland

1 site · Ended

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Klinika Nowotworów Płuca i Klatki Piersiowej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw

Portugal

3 sites · Ended

Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.

Serviço de Oncologia Médica, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto

Unidade Local De Saude De Santo Antonio E.P.E.

Serviço de Oncologia, Largo Professor Abel Salazar, 4050-011, Porto

Hospital Cuf Descobertas S.A.

Serviço de Oncologia, Rua Mario Botas 1, 1998-018, Lisbon

Romania

5 sites · Ended

Oncomed S.R.L.

Oncologie Medicala, Strada Porumbescu Ciprian Nr 59, 300239, Timisoara

Centrul De Oncologie SF Nectarie S.R.L.

Oncologie, Strada Caracal Nr 109, 200542, Craiova

Medicover S.R.L.

Oncologie, Strada Grigore Alexandrescu 16-20 District 1, 010626, Bucharest

Radiotherapy Center Cluj S.R.L.

Oncologie, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti

Mnt Healthcare Europe S.R.L.

Oncologie Medicala, Bulevardul Ficusului 40, 013975, Bucharest

Spain

4 sites · Ended

Hospital Universitario Quironsalud Madrid

Oncologia, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon

Complexo Hospitalario Universitario De Santiago

Oncologia, Calle Choupana Da S/n, 15706, Santiago De Compostela

Hospital Clinic De Barcelona

Oncologia, Calle Villarroel 170, 08036, Barcelona

Hospital Universitari Vall D Hebron

Oncologia, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end
Czechia	2024-10-16	2025-06-04	2024-10-24	2024-12-16
Germany	2022-09-08	2026-02-26	2023-01-18	2024-12-16
Greece	2022-11-24	2026-05-06	2022-12-20	2024-12-16
Italy	2022-09-19	2026-03-09	2022-11-18	2024-12-16
Portugal	2023-02-07	2026-03-10	2023-02-16	2024-12-16
Romania	2023-04-21	2026-04-21	2023-09-29	2024-12-16
Spain	2022-04-29	2025-12-18	2022-05-04	2024-12-16

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 113 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol_2022-502752-31_SM06_for pub	04R
Protocol (for publication)	D1_Protocol_2022-502752-31-00_GRC_EL_SM06_for pub	4R
Protocol (for publication)	D4_Copyright statement_SM06_for pub	04DEC2024
Protocol (for publication)	D4_Subject questionnaire_eCOA screen report_FRA_FR_for pub	1.00R
Protocol (for publication)	D4_Subject questionnaire_eCOA_AUT_DE_for pub	2.00R
Recruitment arrangements (for publication)	CTIS Placeholder document_Version 2_for pub	2
Recruitment arrangements (for publication)	K1_Recruitment Arrangements and IC Procedure_AUT_EN_for pub	1.0
Recruitment arrangements (for publication)	K1_Recruitment Arrangements and IC Procedure_CZE_CS_for pub	20May2024
Recruitment arrangements (for publication)	K1_Recruitment Arrangements and IC Procedure_DEU_EN_for pub	1.0R
Recruitment arrangements (for publication)	K1_Recruitment Arrangements and IC Procedure_FRA_FR_for pub	19Sep2024
Recruitment arrangements (for publication)	K1_Recruitment Arrangements and IC Procedure_HRV_EN_for pub	01JUL2024
Recruitment arrangements (for publication)	K1_Recruitment Arrangements and IC Procedure_ITA_EN_for pub	1.0
Recruitment arrangements (for publication)	K1_Recruitment Arrangements and IC Procedure_POL_PL__for pub	1.0
Recruitment arrangements (for publication)	K1_Recruitment Arrangements and IC Procedure_ROU_RO_for pub	04MAR2024
Recruitment arrangements (for publication)	K1_Recruitment Arrangements_ESP_ES_for pub	28DEC2021R
Recruitment arrangements (for publication)	K1_Recruitment Arrangements_PRT_PT_for pub	04MAR2022
Recruitment arrangements (for publication)	K2_Recruitment Doc Master Tissue Brochure_ROU_EN_for pub	03NOV2021
Recruitment arrangements (for publication)	K2_Recruitment Doc Master Tissue Brochure_ROU_RO_for pub	03NOV2021
Recruitment arrangements (for publication)	K2_Recruitment Doc Patient Brochure_DEU_DE_for pub	03NOV2021
Recruitment arrangements (for publication)	K2_Recruitment Doc Patient Brochure_ROU_EN_for pub	03NOV2021
Recruitment arrangements (for publication)	K2_Recruitment Doc Patient Brochure_ROU_RO_for pub	03NOV2021
Recruitment arrangements (for publication)	K2_Recruitment Doc Patient Visit Guide_Arm A_ROU_EN_for pub	03NOV2021
Recruitment arrangements (for publication)	K2_Recruitment Doc Patient Visit Guide_Arm A_ROU_RO_for pub	03NOV2021
Recruitment arrangements (for publication)	K2_Recruitment Doc Patient Visit Guide_Arm B_ROU_EN_for pub	03NOV2021
Recruitment arrangements (for publication)	K2_Recruitment Doc Patient Visit Guide_Arm B_ROU_RO_for pub	03NOV2021
Recruitment arrangements (for publication)	K2_Recruitment Doc Poster_ROU_EN_for pub	03NOV2021
Recruitment arrangements (for publication)	K2_Recruitment Doc Poster_ROU_RO_for pub	03NOV2021
Subject information and informed consent form (for publication)	L1_ICF_FBR adult consent_DEU_DE_for pub	01
Subject information and informed consent form (for publication)	L1_ICF_FBR consent_AUT_DE_for pub	0.01R
Subject information and informed consent form (for publication)	L1_ICF_FBR consent_CZE_CS_for pub	1.0
Subject information and informed consent form (for publication)	L1_ICF_FBR Consent_ESP_ES_for pub	v01
Subject information and informed consent form (for publication)	L1_ICF_FBR consent_FRA_FR_for pub	00R
Subject information and informed consent form (for publication)	L1_ICF_FBR consent_GRC_EL_for pub	01
Subject information and informed consent form (for publication)	L1_ICF_FBR consent_ITA_IT_for pub	01
Subject information and informed consent form (for publication)	L1_ICF_FBR consent_POL_PL_for pub	01
Subject information and informed consent form (for publication)	L1_ICF_FBR consent_PRT_PT_for pub	AM01.1.00
Subject information and informed consent form (for publication)	L1_ICF_FBR consent_ROU_EN_for pub	v01
Subject information and informed consent form (for publication)	L1_ICF_FBR consent_ROU_RO_for pub	v01
Subject information and informed consent form (for publication)	L1_ICF_FBR data privacy_ITA_IT_for pub	18SEP2023
Subject information and informed consent form (for publication)	L1_ICF_FBR_HRV_HR_for pub	00
Subject information and informed consent form (for publication)	L1_ICF_Genetic consent_PRT_PT_for pub	AM01.1.00
Subject information and informed consent form (for publication)	L1_ICF_Main addendum changes to trial_PRT_PT_SM06_for pub	00
Subject information and informed consent form (for publication)	L1_ICF_Main addendum disease progression_AUT_DE_for pub	1.00
Subject information and informed consent form (for publication)	L1_ICF_Main addendum disease progression_CZE_CS_for pub	1.0
Subject information and informed consent form (for publication)	L1_ICF_Main addendum disease progression_DEU_DE_for pub	1.00
Subject information and informed consent form (for publication)	L1_ICF_Main addendum disease progression_FRA_FR_for pub	00
Subject information and informed consent form (for publication)	L1_ICF_Main addendum disease progression_HRV_HR_for pub	00
Subject information and informed consent form (for publication)	L1_ICF_Main addendum disease progression_POL_PL_for pub	AM01v1.00
Subject information and informed consent form (for publication)	L1_ICF_Main addendum disease progression_PRT_PT_for pub	AM01.1.00
Subject information and informed consent form (for publication)	L1_ICF_Main addendum disease progression_ROU_EN_for pub	AM01v1.00
Subject information and informed consent form (for publication)	L1_ICF_Main addendum disease progression_ROU_RO_for pub	AM01v1.00
Subject information and informed consent form (for publication)	L1_ICF_Main addendum study changes_DEU_DE_SM06_for pub	00
Subject information and informed consent form (for publication)	L1_ICF_Main addendum study changes_ITA_IT_SM06_for pub	00
Subject information and informed consent form (for publication)	L1_ICF_Main addendum study changes_ROU_EN_SM06_for pub	00
Subject information and informed consent form (for publication)	L1_ICF_Main addendum study changes_ROU_RO_SM06_for pub	00
Subject information and informed consent form (for publication)	L1_ICF_Main addendum_CZE_CS_SM06_for pub	1
Subject information and informed consent form (for publication)	L1_ICF_Main addendum_ESP_ES_SM06_for pub	0.00
Subject information and informed consent form (for publication)	L1_ICF_Main addendum_GRC_EL_for pub	1.0
Subject information and informed consent form (for publication)	L1_ICF_Main addendum_GRC_EL_SM06_for pub	00
Subject information and informed consent form (for publication)	L1_ICF_Main consent_AUT_DE_for pub	1.02R
Subject information and informed consent form (for publication)	L1_ICF_Main consent_CZE_CS_for pub	2.0R
Subject information and informed consent form (for publication)	L1_ICF_Main consent_DEU_DE_for pub	1.02R
Subject information and informed consent form (for publication)	L1_ICF_Main Consent_ESP_ES_for pub	AM01v1.02R
Subject information and informed consent form (for publication)	L1_ICF_Main consent_FRA_FR_for pub	19Sep2024
Subject information and informed consent form (for publication)	L1_ICF_Main consent_GRC_EL_SM06_for pub	AM01v1.03
Subject information and informed consent form (for publication)	L1_ICF_Main consent_HRV_HR_for pub	00R
Subject information and informed consent form (for publication)	L1_ICF_Main consent_ITA_IT_for pub	AM01v1.02
Subject information and informed consent form (for publication)	L1_ICF_Main consent_POL_PL_for pub	AM01v1.02R
Subject information and informed consent form (for publication)	L1_ICF_Main consent_PRT_PT_SM06_for pub	AM01v1.03
Subject information and informed consent form (for publication)	L1_ICF_Main consent_ROU_EN_SM06_for pub	AM01v1.03
Subject information and informed consent form (for publication)	L1_ICF_Main consent_ROU_RO_SM06_for pub	AM01v1.03
Subject information and informed consent form (for publication)	L1_ICF_Main data privacy_ITA_IT_for pub	18SEP2023
Subject information and informed consent form (for publication)	L1_ICF_Main GDPR_CZE_CS_for pub	3.0
Subject information and informed consent form (for publication)	L1_ICF_Optional_add crossborder_DEU_DE_for pub	00R
Subject information and informed consent form (for publication)	L1_ICF_Optional_addendum_progression consent_ESP_ES_for pub	AM01v1.00
Subject information and informed consent form (for publication)	L1_ICF_Optional_addendum_progression consent_ITA_IT_for pub	1.00
Subject information and informed consent form (for publication)	L1_ICF_Optional_ClinCard_PRT_PT_SM06_for pub	AM01v1.00
Subject information and informed consent form (for publication)	L1_ICF_Optional_ClinCard_ROU_EN_SM06_for pub	AM01v1.01
Subject information and informed consent form (for publication)	L1_ICF_Optional_ClinCard_ROU_RO_SM06_for pub	AM01v1.01
Subject information and informed consent form (for publication)	L1_ICF_Optional_DILI sample_ITA_IT_for pub	18SEP2023
Subject information and informed consent form (for publication)	L1_ICF_Optional_Greenphire adults_GRC_EL_SM06_for pub	1.00
Subject information and informed consent form (for publication)	L1_ICF_Optional_pregnancy follow-up_PRT_PT_for pub	0.00
Subject information and informed consent form (for publication)	L1_ICF_Optional_pregnant participant_HRV_HR_for pub	00
Subject information and informed consent form (for publication)	L1_ICF_Optional_pregnant partner assent_HRV_HR_for pub	00
Subject information and informed consent form (for publication)	L1_ICF_Optional_pregnant partner data privacy_ITA_IT_for pub	28FEB2024
Subject information and informed consent form (for publication)	L1_ICF_Optional_pregnant partner parent-caregiver_HRV_HR_for pub	00
Subject information and informed consent form (for publication)	L1_ICF_Optional_pregnant partner_ESP_ES_SM06_for pub	0.00R
Subject information and informed consent form (for publication)	L1_ICF_Optional_pregnant partner_HRV_HR_for pub	00
Subject information and informed consent form (for publication)	L1_ICF_Optional_pregnant partner_ITA_IT_for pub	18SEP2023
Subject information and informed consent form (for publication)	L1_ICF_Optional_withdrawal_ESP_ES_for pub	v00
Subject information and informed consent form (for publication)	L1_ICF_Optional_withdrawal_PRT_PT_for pub	0.00
Subject information and informed consent form (for publication)	L1_Patient Advocacy_AUT_DE_for pub	1.0
Subject information and informed consent form (for publication)	L1_Patient contacts per site_3101_AUT_DE_for pub	08APR2024R
Subject information and informed consent form (for publication)	L1_Patient ID Card_CZE_CS_for pub	1.0 00 1.2
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC RSI_Durvalumab_SM09_for pub	22Aug2025
Synopsis of the protocol (for publication)	D1_PPLS_2022-502752-31_ESP_ES_SM06_for pub	2.0
Synopsis of the protocol (for publication)	D1_PPLS_2022-502752-31_FRA_FR_for pub	1.0
Synopsis of the protocol (for publication)	D1_PPLS_2022-502752-31_GRC_EL_SM06_for pub	2.0
Synopsis of the protocol (for publication)	D1_PPLS_2022-502752-31_ITA_IT_SM06_for pub	2.0
Synopsis of the protocol (for publication)	D1_PPLS_2022-502752-31_POL_PL__for pub	1.0
Synopsis of the protocol (for publication)	D1_PPLS_2022-502752-31_PRT_PT_SM06_for pub	2.0
Synopsis of the protocol (for publication)	D1_PPLS_2022-502752-31_ROU_RO_SM06_for pub	2.0
Synopsis of the protocol (for publication)	D1_PPLS_2022-502752-31_SM06_for pub	2.0
Synopsis of the protocol (for publication)	D1_PPLS_2022-502752-31-00_CZE_CS_SM06_for pub	2
Synopsis of the protocol (for publication)	D1_PPLS_DEU_DE_2022-502752-31_for pub	1.0
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis_2021-005135-23-00_CZE_CS_SM06_for pub	2
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis_2022-502752-31_AUT_DE_for pub	02R
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis_2022-502752-31_ROU_RO_SM06_for pub	04
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis_DEU_DE_2022-502752-31-00_for pub	15SEP2022R
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis_ESP_ES_for pub	v01R
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis_GRC_EL_2022-502752-31_for pub	1-0
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis_ITA_IT_for pub	v2.0R
Synopsis of the protocol (for publication)	D1_Protocol Scientific Synopsis_PRT_PT_2022-502752-31-00_for pub	04R

Application history

12 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-07-31	Spain	Acceptable 2023-09-11	2023-09-11
2	SUBSTANTIAL MODIFICATION	SM-1	2023-10-19	Spain	Acceptable 2023-12-29	2023-12-29
3	SUBSTANTIAL MODIFICATION	SM-2	2024-03-21	Spain	Acceptable 2024-06-26	2024-06-26
4	SUBSEQUENT ADDITION OF MSC	APP-4	2024-07-09		Acceptable 2024-06-26	2024-10-03
5	SUBSEQUENT ADDITION OF MSC	APP-5	2024-07-09		Acceptable 2024-06-26	2024-10-07
6	SUBSEQUENT ADDITION OF MSC	APP-6	2024-07-10		Acceptable 2024-06-26	2024-10-07
7	SUBSEQUENT ADDITION OF MSC	APP-7	2024-07-10			2024-10-02
8	SUBSEQUENT ADDITION OF MSC	APP-8	2024-07-11		Acceptable 2024-06-26	2024-09-30
9	SUBSTANTIAL MODIFICATION	SM-6	2025-03-20	Spain	Acceptable 2025-05-26	2025-05-26
10	SUBSTANTIAL MODIFICATION	SM-7	2025-07-25		Acceptable	2025-09-04
11	NON SUBSTANTIAL MODIFICATION	NSM-4	2025-12-11		Acceptable	2025-12-11
12	SUBSTANTIAL MODIFICATION	SM-8	2025-12-19	Spain	Acceptable 2026-03-09	2026-03-10

A study of MK7684A in Combination with radiation and chemotherapy versus radiation and chemotherapy followed by Durvalumab for patients with Stage III lung cancer that cannot be surgically treated

Overview

Key facts

External identifiers

Trial design

Main objective

Conditions and MedDRA coding

Regulatory references

Eligibility criteria

Inclusion criteria 9

Exclusion criteria 17

Endpoints

Primary endpoints 1

Investigational products

Test 1

Comparator 2

Auxiliary 7

Sponsors and contacts

Merck Sharp & Dohme LLC

Scientific contact point

Public contact point

Third parties 9

Locations

By country

Investigational sites

Country notifications

Results and documents

Documents 113 files

Application history

Related clinical trials