A study of RMC-6236 in combination with pembrolizumab in participants with nonsmall cell lung cancer with certain mutations -Subprotocol B

2023-509572-42-00 Protocol RMC-LUNG-101B Human pharmacology (Phase I) - Other Ongoing, recruiting

Start 17 Jul 2024 · Status Ongoing, recruiting · 5 EU/EEA countries · 41 sites · Protocol RMC-LUNG-101B

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ongoing, recruiting
Participants planned 356
Countries 5
Sites 41

Lung Cancer

To evaluate the safety and tolerability of RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with advanced RAS- mutated NSCLC

Key facts

Sponsor
Revolution Medicines Inc.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Respiratory Tract Diseases [C08]
Trial duration
17 Jul 2024 → ongoing
Decision date (initial)
2024-07-01
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Revolution Medicines Inc

External identifiers

EU CT number
2023-509572-42-00
ClinicalTrials.gov
NCT06162221

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Dose response

To evaluate the safety and tolerability of RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with advanced RAS- mutated NSCLC

Secondary objectives 2

  1. To characterize the blood PK profile of RMC-6236 in combination with pembrolizumab in patients with advanced RAS-mutated NSCLC
  2. To evaluate preliminary antitumor effects of RMC-6236 in combination with embrolizumab, with or without chemotherapy, in patients with advanced RAS-mutated NSCLC

Conditions and MedDRA coding

Lung Cancer

VersionLevelCodeTermSystem organ class
21.1 PT 10061873 Non-small cell lung cancer 100000004864

Study design 2 periods

#TitleAllocationBlindingRoles blindedArms
1 A Phase 1b/2 Open-Label, Multicenter Study of RMC-6236 in Combination with Pembrolizumab with or
Phase 1b/2
 2 None
2 without Chemotherapy, in Patients with RAS‑Mutated Non-Small Cell Lung Cancer (NSCLC)-Subprotocol B
Phase 1b/2
 2 None

Regulatory references

Plan to share IPD
No
EU CT numberTitleSponsor
2023-509571-16-00 A Phase 1b/2 Open-Label, Multicenter Study of RMC-6291 in Combination with Pembrolizumab with or without Chemotherapy, in Patients with KRASG12C-Mutated Solid Tumors – Subprotocol A Revolution Medicines Inc.
2023-508178-27-00 RMC-6291-101 Phase 1b, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRASG12C-Mutated Solid Tumors Revolution Medicines Inc.
2024-516063-89-00 RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of RMC-6236 versus Investigator’s Choice of Standard of Care Therapy in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Revolution Medicines Inc.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

  1. Patients that are at least 18 years old. Patients that have NSCLC with certain RAS mutations. Patients that have NSCLC that is unlikely to be cured and has spread to other body parts. Patients that have received prior cancer treatment. Patients that have at least one tumor lesion (an area of abnormal tissue) that can be measured. Patients that have adequate organ function (bone marrow, liver, kidney).

Exclusion criteria 1

  1. 1. Participants that have primary brain and spinal cord tumor spreading to other body parts. 2. Participants that have gastrointestinal problems that may affect absorption of RMC-6236. 3. Participants that had any major surgery in the last 4 weeks. 4. Participants that have have previously taken targeted therapy for RAS mutation. 5. Participants that have any other medical condition that may interfere with the study drugs.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. • Incidence of DLTs (Part 1 and Part 2 Cohort 2 safety lead-in only)
  2. •Incidence of TEAEs, TRAEs, SAEs, and clinically significant changes in laboratory test values, ECGs, and vital signs

Secondary endpoints 2

  1. • Concentrations of RMC-6236 in plasma over time and PK parameters as applicable.
  2. • ORR and DOR per RECIST v1.1

Investigational products

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

Test 26

Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

PRD669106 · Product

Active substance
Carboplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
35.71 mg milligram(s)
Max total dose
750 mg milligram(s)
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01XA02 — CARBOPLATIN
Marketing authorisation
84223.00.00
MA holder
FRESENIUS KABI DEUTSCHLAND GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Carboplatin-Ebewe, 10 Mg/Ml, Koncentrat Do Sporządzania Roztworu Do Infuzji

PRD766560 · Product

Active substance
Carboplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
35.71 mg milligram(s)
Max total dose
750 mg milligram(s)
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01XA02 — CARBOPLATIN
Marketing authorisation
4500
MA holder
EBEWE PHARMA
MA country
Poland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

CARBO-cell® 10 mg/ml Infusionslösung, Konzentrat zur Herstellung einer Infusionslösung

PRD1972920 · Product

Active substance
Carboplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
35.71 mg milligram(s)
Max total dose
750 mg milligram(s)
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01XA02 — CARBOPLATIN
Marketing authorisation
46298.00.00
MA holder
STADAPHARM GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatinum Accord, 1 mg/ml, koncentrat do sporządzania roztworu do infuzji.

PRD1951612 · Product

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
3.57 mg/m2 milligram(s)/sq. meter
Max total dose
75 mg/m2 milligram(s)/sq. meter
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01XA01 — CISPLATIN
Marketing authorisation
17743
MA holder
ACCORD HEALTHCARE POLSKA SP. Z O.O.
MA country
Poland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatinum Accord, 1 mg/ml, koncentrat do sporządzania roztworu do infuzji.

PRD1951611 · Product

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
3.57 mg/m2 milligram(s)/sq. meter
Max total dose
75 mg/m2 milligram(s)/sq. meter
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01XA01 — CISPLATIN
Marketing authorisation
17743
MA holder
ACCORD HEALTHCARE POLSKA SP. Z O.O.
MA country
Poland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatinum Accord, 1 mg/ml, koncentrat do sporządzania roztworu do infuzji.

PRD415232 · Product

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
3.57 mg/m2 milligram(s)/sq. meter
Max total dose
75 mg/m2 milligram(s)/sq. meter
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01XA01 — CISPLATIN
Marketing authorisation
17743
MA holder
ACCORD HEALTHCARE POLSKA SP. Z O.O.
MA country
Poland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatinum Accord, 1 mg/ml, koncentrat do sporządzania roztworu do infuzji.

PRD1951610 · Product

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
3.57 mg/m2 milligram(s)/sq. meter
Max total dose
75 mg/m2 milligram(s)/sq. meter
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01XA01 — CISPLATIN
Marketing authorisation
17743
MA holder
ACCORD HEALTHCARE POLSKA SP. Z O.O.
MA country
Poland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

KEYTRUDA 25 mg/mL concentrate for solution for infusion

PRD4323105 · Product

Active substance
Pembrolizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
9.52 mg milligram(s)
Max total dose
200 mg milligram(s)
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01FF02 — -
Marketing authorisation
EU/1/15/1024/002
MA holder
MERCK SHARP & DOHME B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

KEYTRUDA 25 mg/mL concentrate for solution for infusion

PRD4323786 · Product

Active substance
Pembrolizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
9.52 mg milligram(s)
Max total dose
200 mg milligram(s)
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01FF02 — -
Marketing authorisation
EU/1/15/1024/002
MA holder
MERCK SHARP & DOHME B.V.
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

KEYTRUDA 25 mg/mL concentrate for solution for infusion

PRD4323784 · Product

Active substance
Pembrolizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
9.52 mg milligram(s)
Max total dose
200 mg milligram(s)
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01FF02 — -
Marketing authorisation
EU/1/15/1024/002
MA holder
MERCK SHARP & DOHME B.V.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

KEYTRUDA 25 mg/mL concentrate for solution for infusion

PRD4323785 · Product

Active substance
Pembrolizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
9.52 mg milligram(s)
Max total dose
200 mg milligram(s)
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01FF02 — -
Marketing authorisation
EU/1/15/1024/002
MA holder
MERCK SHARP & DOHME B.V.
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung

PRD9682731 · Product

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
3.57 mg/m2 milligram(s)/sq. meter
Max total dose
75 mg/m2 milligram(s)/sq. meter
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01XA01 — CISPLATIN
Marketing authorisation
2205259.00.00
MA holder
HIKMA FARMACÊUTICA (PORTUGAL), S.A.
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatin-Ebewe, 1 Mg/Ml, Koncentrat Do Sporządzania Roztworu Do Infuzji

PRD771236 · Product

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
3.57 mg/m2 milligram(s)/sq. meter
Max total dose
75 mg/m2 milligram(s)/sq. meter
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01XA01 — CISPLATIN
Marketing authorisation
19903
MA holder
EBEWE PHARMA
MA country
Poland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung

PRD9682730 · Product

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
3.75 mg/m2 milligram(s)/sq. meter
Max total dose
75 mg/m2 milligram(s)/sq. meter
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01XA01 — CISPLATIN
Marketing authorisation
2205259.00.00
MA holder
HIKMA FARMACÊUTICA (PORTUGAL), S.A.
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Daraxonrasib (RMC-6236)

PRD10818588 · Product

Active substance
(12M-1S2S-N-63S4SZ-11-ETHYL-12-2-S-1-METHOXYETHYL-5-4-METHYLPIPERAZIN-1-YLPYRIDIN-3-YL-1010-DIMETHYL-57-DIOXO-616263646566-HEXAHYDRO-11H-8-OXA-242-THIAZOLA-153-INDOLA-613-PYRIDAZINACYCLOUNDECAPHANE-4-YL-2-METHYLCYCLOPROPANE-1-CARBOXAMIDE
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
400 mg milligram(s)
Max total dose
400 mg milligram(s)
Max treatment duration
9 Month(s)
Authorisation status
Not Authorised
MA holder
REVOLUTION MEDICINES INC.
Paediatric formulation
No
Orphan designation
No

Daraxonrasib (RMC-6236)

PRD10818590 · Product

Active substance
(12M-1S2S-N-63S4SZ-11-ETHYL-12-2-S-1-METHOXYETHYL-5-4-METHYLPIPERAZIN-1-YLPYRIDIN-3-YL-1010-DIMETHYL-57-DIOXO-616263646566-HEXAHYDRO-11H-8-OXA-242-THIAZOLA-153-INDOLA-613-PYRIDAZINACYCLOUNDECAPHANE-4-YL-2-METHYLCYCLOPROPANE-1-CARBOXAMIDE
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
400 mg milligram(s)
Max total dose
400 mg milligram(s)
Max treatment duration
9 Month(s)
Authorisation status
Not Authorised
MA holder
REVOLUTION MEDICINES INC.
Paediatric formulation
No
Orphan designation
No

Daraxonrasib (RMC-6236)

PRD10818589 · Product

Active substance
(12M-1S2S-N-63S4SZ-11-ETHYL-12-2-S-1-METHOXYETHYL-5-4-METHYLPIPERAZIN-1-YLPYRIDIN-3-YL-1010-DIMETHYL-57-DIOXO-616263646566-HEXAHYDRO-11H-8-OXA-242-THIAZOLA-153-INDOLA-613-PYRIDAZINACYCLOUNDECAPHANE-4-YL-2-METHYLCYCLOPROPANE-1-CARBOXAMIDE
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
400 mg milligram(s)
Max total dose
400 mg milligram(s)
Max treatment duration
9 Month(s)
Authorisation status
Not Authorised
MA holder
REVOLUTION MEDICINES INC.
Paediatric formulation
No
Orphan designation
No

Pemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion

PRD8139709 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
23.8 mg/m2 milligram(s)/sq. meter
Max total dose
500 mg/m2 milligram(s)/sq. meter
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
EU/1/16/1115/001
MA holder
FRESENIUS KABI DEUTSCHLAND GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed Synthon 25 mg/ml, concentraat voor oplossing voor infusie

PRD5986697 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
23.8 mg/m2 milligram(s)/sq. meter
Max total dose
500 mg/m2 milligram(s)/sq. meter
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
RVG 120309
MA holder
SYNTHON BV
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion

PRD4287595 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
23.8 mg/m2 milligram(s)/sq. meter
Max total dose
500 mg/m2 milligram(s)/sq. meter
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
EU/1/16/1115/001
MA holder
FRESENIUS KABI DEUTSCHLAND GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion

PRD8139711 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
23.8 mg/m2 milligram(s)/sq. meter
Max total dose
500 mg/m2 milligram(s)/sq. meter
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
EU/1/16/1115/001
MA holder
FRESENIUS KABI DEUTSCHLAND GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion

PRD8139710 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
23.8 mg/m2 milligram(s)/sq. meter
Max total dose
500 mg/m2 milligram(s)/sq. meter
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
EU/1/16/1115/001
MA holder
FRESENIUS KABI DEUTSCHLAND GMBH
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion

PRD4287910 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
23.8 mg/m2 milligram(s)/sq. meter
Max total dose
500 mg/m2 milligram(s)/sq. meter
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
EU/1/16/1115/001
MA holder
FRESENIUS KABI ONCOLOGY PLC.
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion

PRD4287914 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
23.8 mg/m2 milligram(s)/sq. meter
Max total dose
500 mg/m2 milligram(s)/sq. meter
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
EU/1/16/1115/001
MA holder
FRESENIUS KABI ONCOLOGY PLC.
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed STADA 25 mg/ml Konzentrat zur Herstellung einer Infusionslösung

PRD7905952 · Product

Active substance
Pemetrexed
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
23.8 mg/m2 milligram(s)/sq. meter
Max total dose
500 mg/m2 milligram(s)/sq. meter
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
99025.00.00
MA holder
STADAPHARM GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion

PRD4287912 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
23.8 mg/m2 milligram(s)/sq. meter
Max total dose
500 mg/m2 milligram(s)/sq. meter
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
EU/1/16/1115/001
MA holder
FRESENIUS KABI ONCOLOGY PLC.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Revolution Medicines Inc.

9 Total trials 5 Recruiting 3 Ended
Commercial
Sponsor organisation
Revolution Medicines Inc.
Address
700 Saginaw Drive
City
Redwood City
Postcode
94063-4752
Country
United States

Scientific contact point

Organisation
Revolution Medicines Inc.
Contact name
Melanie Caruno

Public contact point

Organisation
Revolution Medicines Inc.
Contact name
Melanie Caruno

Third parties 17

OrganisationCity, countryDuties
Discovery Life Sciences LLC
ORG-100046461
 Huntsville, United States Laboratory analysis
Propharma Group LLC
ORG-100048652
 Raleigh, United States Code 9
Myonex LLC
ORG-100047430
 Horsham, United States Other
Sherpa Clinical Packaging LLC
ORG-100042876
 San Diego, United States Other
Aperio Clinical Outcomes LLC
ORG-100046387
 Durham, United States Data management
Perceptive Informatics Inc.
ORG-100013171
 Billerica, United States Other
Primevigilance Limited
ORG-100027742
 Guildford, United Kingdom Code 8
Biotel Research LLC
ORG-100039864
 Rochester, United States Other
Atreo Inc.
ORG-100045217
 San Francisco, United States Interactive response technologies (IRT)
Scout Clinical
ORG-100042228
 Dallas, United States Other
Edetek Inc.
ORG-100045957
 Princeton, United States Other
Alturas Analytics Inc.
ORG-100045347
 Moscow, United States Laboratory analysis
Adaptive Biotechnologies Corp.
ORG-100044428
 Seattle, United States Laboratory analysis
Tempus Labs Inc.
ORG-100044006
 Chicago, United States Laboratory analysis
PPD Development LP
ORG-100011560
 Wilmington, United States Other
Medidata Solutions Inc.
ORG-100016256
 New York, United States Other
Guardant Health Inc.
ORG-100042461
 Redwood City, United States Other

Locations

5 EU/EEA countries · 41 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ongoing, recruiting 36 10
Germany Ongoing, recruiting 36 7
Italy Ongoing, recruiting 36 7
Netherlands Ongoing, recruiting 36 4
Spain Ongoing, recruiting 36 13
Rest of world
United States
 — 176 —

Investigational sites

France

10 sites · Ongoing, recruiting
Oncopole Claudius Regaud
Medical Oncology Department, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Curie
N/A, 26 Rue D Ulm, 75005, Paris
Institut Gustave Roussy
DITEP (Medical Oncology in Early Drug Development Department), 114 Rue Edouard Vaillant, 94800, Villejuif
Centr Georges Francois Leclerc
N/A, 1 Rue Professeur Marion, 21000, Dijon
Institut Bergonie
N/A, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Hospitalier Universitaire De Lille
N/A, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Hospital Foch
N/A, 40 Rue Worth, 92150, Suresnes
Centre Hospitalier Universitaire De Nantes
N/A, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Hospices Civils De Lyon
N/A, 28 Avenue Du Doyen Jean Lepine, 69500, Bron
Centre Francois Baclesse
N/A, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5

Germany

7 sites · Ongoing, recruiting
Lungenfachklinik Immenhausen
N/A, Robert-Koch-Straße 3, 34376, Immenhausen
University Hospital Cologne AöR
Klinik I für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne
Technische Universitaet Dresden
Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Thoraxklinik Heidelberg gGmbH
Universitätsklinikum Heidelberg, Roentgenstrasse 1, Rohrbach, Heidelberg
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Onkologie, Hämatologie und Tumorimmunologie, Hindenburgdamm 30, Lichterfelde, Berlin
Stiftung Krankenhaus Bethanien Fuer Die Grafschaft Moers
Klinik für Lungen- & Bronchialheilkunde, Bethanienstrasse 21, Innenstadt, Moers
Goethe University Frankfurt
Medizinische Klinik II, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main

Italy

7 sites · Ongoing, recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Unità Operativa Complessa Fase 1, Largo Agostino Gemelli 8, 00168, Rome
I.F.O. Istituti Fisioterapici Ospitalieri
UOSD Clinical Trial Unit Phase 1and Precision Medicine, Via Elio Chianesi N 53, 00144, Rome
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department: SSD Oncologia polmonare-A.O.U. San Luigi Gonzaga - Orbassano, Regione Gonzole 10, 10043, Orbassano
Azienda Unita Sanitaria Locale Della Romagna
Unità Clinica Fase 1 – UO Oncologia di Ravenna, Viale Vincenzo Randi 5, 48121, Ravenna
Fondazione IRCCS Istituto Nazionale Dei Tumori
Medical Oncology and Hematology, Via Giacomo Venezian 1, 20133, Milan
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
ASST Grande Ospedale Metropolitano Niguarda
Department: SC Oncologia Falck, Piazza Dell'ospedale Maggiore 3, 20162, Milan

Netherlands

4 sites · Ongoing, recruiting
Leids Universitair Medisch Centrum (LUMC)
Department of Pulmonary Diseases, Albinusdreef 2, 2333 ZA, Leiden
Universitair Medisch Centrum Groningen
Dept. of pulmonology and tuberculosis, Hanzeplein 1, 9713 GZ, Groningen
Universitair Medisch Centrum Utrecht
Medical Oncology, Heidelberglaan 100, 3584 CX, Utrecht
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Clinical Research Unit, Plesmanlaan 121, 1066 CX, Amsterdam

Spain

13 sites · Ongoing, recruiting
Hospital Clinico San Carlos
Oncologia, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Universitario Y Politecnico La Fe
Oncologia, Avenida De Fernando Abril Martorell 106, 46026, Valencia
University Hospital Virgen Del Rocio S.L.
Oncologia, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Fundacion Jimenez Diaz
Oncologia, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario 12 De Octubre
Oncologia, Bloque D, Avenida De Cordoba Sn, Madrid
Fundacion Instituto Valenciano De Oncologia
Oncologia, Calle Professor Beltran Baguena 8, 46009, Valencia
Clinica Universidad De Navarra
Oncologia, Avenue Pio XII 36, 31008, Pamplona
Clinica Universidad De Navarra
Oncologia, Calle Marquesado De Santa Marta 1, 28027, Madrid
Institut Catala D'oncologia
Oncologia, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario Regional De Malaga
Oncologia Medica, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Universitari Vall D Hebron
Oncologia, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Ramon Y Cajal
Oncologia, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Complexo Hospitalario Universitario A Coruna
Oncologia Medica, Lugar Jubias De Arriba 84, 15006, A Coruna

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2024-07-17 2024-07-26
Germany 2024-09-04 2024-11-29
Italy 2024-08-07 2024-10-23
Netherlands 2024-08-16 2024-11-21
Spain 2024-07-24 2024-08-13

Results and documents

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

Documents 60 files

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

TypeTitleVersion
Protocol (for publication) D1_RevMed_RMC-LUNG-101_Core Protocol_2023-509572-42_Public 5.1
Protocol (for publication) D1_RevMed_RMC-LUNG-101B_SubProtocol_2023-509572-42_Public 6.1
Protocol (for publication) D4_RevMed_RMC-LUNG-101B_ Patient Diary_DEU_Public 3.0
Protocol (for publication) D4_RevMed_RMC-LUNG-101B_ Patient Diary_ENG_Public 3.0
Protocol (for publication) D4_RevMed_RMC-LUNG-101B_ Patient Diary_ESP_Public 3.0
Protocol (for publication) D4_RevMed_RMC-LUNG-101B_ Patient Diary_FRA_Public 3.0
Protocol (for publication) D4_RevMed_RMC-LUNG-101B_ Patient Diary_ITA_Public 3.0
Protocol (for publication) D4_RevMed_RMC-LUNG-101B_ Patient Diary_NLD_Public 3.0
Protocol (for publication) RevMed_RMC-LUNG-101_Attachment-I protocol_Dose Escalation OC simulation report_Public n/a
Protocol (for publication) RevMed_RMC-LUNG-101_Core Protocol_Signature Page_Public 5.0
Protocol (for publication) RevMed_RMC-LUNG-101_Subprotocol B_Signature Page_ Public 6.1
Recruitment arrangements (for publication) K1_RMC-LUNG-101B_Recruitment_arrangements_NL_English_Public n/a
Recruitment arrangements (for publication) K1_RMC-LUNG-101B_Recruitment-and-Informed-Consent-Procedure_DE_Public 1.0
Recruitment arrangements (for publication) K1_RMC-LUNG-101B_Recruitment-and-Informed-Consent-Procedure_ES_Public 1.0
Recruitment arrangements (for publication) K1_RMC-LUNG-101B_Recruitment-Arrangements_FR_French_Public 1.0
Recruitment arrangements (for publication) K1_RMC-LUNG-101B_Recruitment-Arrangements_IT_Public 1.0
Recruitment arrangements (for publication) K2_RMC-LUNG-101B_GP_letter_IT_Italian_Public 1.0
Subject information and informed consent form (for publication) L1_RMC_LUNG_101B_Main_ICF_Fra_Khmer_Public 7.0
Subject information and informed consent form (for publication) L1_RMC_LUNG_101B_Pregnant_Partner_ICF_Fra_Khmer_Public 5.0
Subject information and informed consent form (for publication) L1_RMC-LUNG-101_Pregnancy ICF_DE_German_Public 5.0
Subject information and informed consent form (for publication) L1_RMC-LUNG-101_Scout ICF_ES_Spanish_Public 0.2
Subject information and informed consent form (for publication) L1_RMC-LUNG-101B_Future Research ICF_DE_German_Public 1.0
Subject information and informed consent form (for publication) L1_RMC-LUNG-101B_Main ICF_DE_German_Public 7.0
Subject information and informed consent form (for publication) L1_RMC-LUNG-101B_Main_ICF_IT_ITA_Public 7.0
Subject information and informed consent form (for publication) L1_RMC-LUNG-101B_Main-ICF_ES_Spanish_Public 7.0
Subject information and informed consent form (for publication) L1_RMC-LUNG-101B_Main-ICF_FR_French_Public 7.0
Subject information and informed consent form (for publication) L1_RMC-LUNG-101B_PP-ICF_ES_Spanish_Public 5.0
Subject information and informed consent form (for publication) L1_RMC-LUNG-101B_Pregnancy-ICF_FR_French_Public 5.0
Subject information and informed consent form (for publication) L1_RMC-LUNG-101B_Pregnant-Partner_ICF_IT_Italian_Public 5.0
Subject information and informed consent form (for publication) L1_RMC-LUNG-101B_Privacy-Addendum_ICF_IT_Italian_Public 1.0
Subject information and informed consent form (for publication) L1_RMC-LUNG-101B_Scout ICF_DE_German_Public 1.0
Subject information and informed consent form (for publication) L1_RMC-LUNG-101B_Scout_ICF_Public 1.0
Subject information and informed consent form (for publication) L1_RMC-LUNG-101B_SIS-and-ICF-adults_NL_Dutch_Public 7.0
Subject information and informed consent form (for publication) L1_RMC-LUNG-101B_SIS-and-ICF-pregnant-partner_NL_Dutch_Public 5.0
Summary of Product Characteristics (SmPC) (for publication) E2_RevMed_RMC-LUNG-101B_SmPCs_CARBO-cell_ENG_Public n/a
Summary of Product Characteristics (SmPC) (for publication) E2_RevMed_RMC-LUNG-101B_SmPCs_Carboplatin Fresenius Kabi_EN_Public n/a
Summary of Product Characteristics (SmPC) (for publication) E2_RevMed_RMC-LUNG-101B_SmPCs_Carboplatin-Ebewe_EN_Public n/a
Summary of Product Characteristics (SmPC) (for publication) E2_RevMed_RMC-LUNG-101B_SmPCs_Cisplatin Hikma_ENG_Public n/a
Summary of Product Characteristics (SmPC) (for publication) E2_RevMed_RMC-LUNG-101B_SmPCs_Cisplatin-Ebewe_ENG_Public n/a
Summary of Product Characteristics (SmPC) (for publication) E2_RevMed_RMC-LUNG-101B_SmPCs_Cisplatino Hikma_ENG_Public n/a
Summary of Product Characteristics (SmPC) (for publication) E2_RevMed_RMC-LUNG-101B_SmPCs_Cisplatinum Accord_ENG_Public n/a
Summary of Product Characteristics (SmPC) (for publication) E2_RevMed_RMC-LUNG-101B_SmPCs_Pembrolizumab_ENG_Public n/a
Summary of Product Characteristics (SmPC) (for publication) E2_RevMed_RMC-LUNG-101B_SmPCs_Pemetrexed Fresenius Kabi_ENG_Public n/a
Summary of Product Characteristics (SmPC) (for publication) E2_RevMed_RMC-LUNG-101B_SmPCs_Pemetrexed STADA _ENG_Public n/a
Summary of Product Characteristics (SmPC) (for publication) E2_RevMed_RMC-LUNG-101B_SmPCs_Pemetrexed Synthon_ENG_Public n/a
Synopsis of the protocol (for publication) D1_RevMed_RMC-LUNG-101_Core Protocol Synopsis_2023-509572-42_FRA_Public 5.1
Synopsis of the protocol (for publication) D1_RevMed_RMC-LUNG-101_Core Protocol Synopsis_2023-509572-42_ITA_Public 5.1
Synopsis of the protocol (for publication) D1_RevMed_RMC-LUNG-101_Core Protocol Synopsis_2023-509572-42_Public 5.1
Synopsis of the protocol (for publication) D1_RevMed_RMC-LUNG-101_Core_Protocol_Synopsis_2023-509572-42_NLD_Public 5.1
Synopsis of the protocol (for publication) D1_RevMed_RMC-LUNG-101_Core-protocol_synopsis_2023-509572-42_ESP_Public 5.1
Synopsis of the protocol (for publication) D1_RevMed_RMC-LUNG-101B_Subprotocol Lay Synopsis_2023-509572-42 _ITA_Public N/A
Synopsis of the protocol (for publication) D1_RevMed_RMC-LUNG-101B_SubProtocol Lay synopsis_2023-509572-42_ESP_Public n/a
Synopsis of the protocol (for publication) D1_RevMed_RMC-LUNG-101B_SubProtocol Lay Synopsis_2023-509572-42_FRA_Public n/a
Synopsis of the protocol (for publication) D1_RevMed_RMC-LUNG-101B_SubProtocol Lay Synopsis_Public 2.0
Synopsis of the protocol (for publication) D1_RevMed_RMC-LUNG-101B_SubProtocol Synopsis_2023-509572-42_FRA_Public 6.1
Synopsis of the protocol (for publication) D1_RevMed_RMC-LUNG-101B_SubProtocol synopsis_2023-509572-42_ITA_Public 6.1
Synopsis of the protocol (for publication) D1_RevMed_RMC-LUNG-101B_SubProtocol Synopsis_2023-509572-42_Public 6.1
Synopsis of the protocol (for publication) D1_RevMed_RMC-LUNG-101B_SubProtocol_Lay Synopsis_2023-509572-42_NLD_Public n/a
Synopsis of the protocol (for publication) D1_RevMed_RMC-LUNG-101B_SubProtocol_synopsis_2023-509572-42_ESP_Public 6.1
Synopsis of the protocol (for publication) D1_RevMed_RMC-LUNG-101B_SubProtocol_Synopsis_2023-509572-42_NLD_Public 6.1

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-03-11 Spain Acceptable
2024-06-24
 2024-06-25
2 SUBSTANTIAL MODIFICATION SM-1 2024-07-09 Acceptable 2024-08-29
3 SUBSTANTIAL MODIFICATION SM-2 2024-07-09 Acceptable 2024-08-06
4 SUBSTANTIAL MODIFICATION SM-3 2024-07-09 Acceptable 2024-08-21
5 SUBSTANTIAL MODIFICATION SM-4 2024-07-09 Spain Acceptable 2024-08-08
6 SUBSTANTIAL MODIFICATION SM-5 2024-07-09 Acceptable 2024-08-14
7 SUBSTANTIAL MODIFICATION SM-6 2024-09-02 Spain Acceptable 2024-09-17
8 SUBSTANTIAL MODIFICATION SM-7 2024-11-07 Spain Acceptable
2025-02-18
 2025-02-18
9 SUBSTANTIAL MODIFICATION SM-12 2025-04-11 Acceptable 2025-05-23
10 SUBSTANTIAL MODIFICATION SM-10 2025-04-14 Spain Acceptable 2025-05-13
11 SUBSTANTIAL MODIFICATION SM-8 2025-04-15 Acceptable 2025-06-17
12 SUBSTANTIAL MODIFICATION SM-11 2025-04-15 Acceptable 2025-05-02
13 SUBSTANTIAL MODIFICATION SM-9 2025-04-23 Acceptable 2025-05-23
14 SUBSTANTIAL MODIFICATION SM-13 2025-09-30 Spain Acceptable
2025-12-22
 2025-12-22
15 NON SUBSTANTIAL MODIFICATION NSM-1 2026-01-12 Acceptable
2025-12-22
 2026-01-12
16 NON SUBSTANTIAL MODIFICATION NSM-2 2026-01-13 Acceptable
2025-12-22
 2026-01-13

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