A Study to Evaluate Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients with Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung)

2023-504038-23-00 Protocol BO39610 Phase I and Phase II (Integrated) - Other Ended

Start 10 May 2018 · End 26 Nov 2025 · Status Ended · 2 EU/EEA countries · 13 sites · Protocol BO39610

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - Other
Status Ended
Participants planned 314
Countries 2
Sites 13

Metastatic non-small cell lung cancer (NSCLC)

Stage 1 To evaluate the efficacy of immunotherapy-based treatment combinations based on objective response (ORR)

Key facts

Sponsor
F. Hoffmann-La Roche AG
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
10 May 2018 → 26 Nov 2025
Decision date (initial)
2024-07-02
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
F. Hoffmann-La Roche AG

External identifiers

EU CT number
2023-504038-23-00
EudraCT number
2017-001267-21

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Stage 1 To evaluate the efficacy of immunotherapy-based treatment combinations based on objective response (ORR)

Secondary objectives 2

  1. Stage 1 To evaluate the efficacy of immunotherapy-based treatment combinations based on progression free survival (PFS), PFS at specific timepoints, overall survival (OS) after randomization and at specific time points, duration of response (DOR) and disease control (DCR)
  2. Stage 1 and 2 To evaluate the safety of immunotherapy-based treatment combinations

Conditions and MedDRA coding

Metastatic non-small cell lung cancer (NSCLC)

VersionLevelCodeTermSystem organ class
21.1 PT 10059515 Non-small cell lung cancer metastatic 100000004864

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 A PHASE Ib/II, STUDY OF MULTIPLE TREATMENT COMBINATIONS IN PATIENTS WITH METASTATIC LUNG CANCER
This is a Phase Ib/II, open-label, multicenter, randomized, umbrella study evaluating the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in patients with metastatic non-small cell lung cancer (NSCLC). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population (e.g., with regard to prior anti-cancer treatment or biomarker status).
 Randomised Controlled None Cohort 1 (Comparator Arm): Atezolizumab + Tiragolumab
Cohort 1 (Experimental Arm): Atezolizumab + Tiragolumab + XL092
Cohort 2 (Control Arm): Docetaxel
Cohort 2 (Experimental Arm): Atezolizumab + Evolocumab
Cohort 2 (Experimental Arm): Atezolizumab + Bevacizumab
Cohort 2 (Experimental Arm): Atezolizumab + Bevacizumab + Radiotherapy
Cohort 2 (Experimental Arm): Atezolizumab + Sacituzumab Govitecan
Cohort 2 (Experimental Arm): Atezolizumab + Camonsertib
Cohort 2 (Experimental Arm): Atezolizumab + Bevacizumab + Camonsertib
Cohort 2 (Experimental Arm): Atezolizumab + Bevacizumab + Tiragolumab

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  1. Histologically or cytologically confirmed metastatic, non-squamous or squamous NSCLC
  2. Availability of a representative tumor specimen that is suitable for determination of PD-L1 and/or additional biomarker status by means of central testing
  3. Stage 1 and 2 Measurable disease according to Response Evaluation Criteria in Solid Tumors, Version 1.1
  4. Stage 1 and 2 Negative HIV test at screening
  5. Stage 1 and 2 Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus DNA test at screening
  6. Stage 1 and 2 Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening

Exclusion criteria 6

  1. Activating mutation in the epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) gene rearrangement
  2. Prior allogeneic stem cell or solid organ transplantation
  3. Treatment with systemic immunostimulatory agents within 4 weeks (or 5 half-lives of the drug, whichever is longer) or systemic immunosuppressive medication within 2 weeks prior to study treatment start
  4. History of malignancy other than NSCLC within 2 years prior to screening with the exception of malignancies with a negligible risk of metastasis or death
  5. Active tuberculosis
  6. Severe infection within 4 weeks prior to initiation of study treatment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Stage 1 1. Objective response rate (ORR)

Secondary endpoints 8

  1. Stage 1 1. PFS
  2. Stage 1 2. PFS at specific time points
  3. Stage 1 3. OS
  4. Stage 1 4. OS at specific time points
  5. Stage 1 5. DOR
  6. Stage 1 6. DCR
  7. Stage 1 and 2 7. Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0
  8. Stage 1 and 2 8. Change from baseline in vital signs, electrocardiogram parameters and targeted clinical laboratory test results

Investigational products

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

Test 5

Camonsertib

PRD10948864 · Product

Active substance
Camonsertib
Substance synonyms
(1R,3r,5S)-3-(6-((R)-3-methylmorpholino)-1-(1H-pyrazol-3-yl)-1H-pyrazolo[3,,4-b]pyridin-4-yl)-8-oxabicyclo[3.2.1]octan-3-ol, RP-3500
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Authorisation status
Not Authorised
MA holder
F. HOFFMANN-LA ROCHE LTD
Paediatric formulation
No
Orphan designation
No

Trajenta 5 mg film-coated tablets

PRD291966 · Product

Active substance
Linagliptin
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Authorisation status
Authorised
ATC code
A10BH05 — -
Marketing authorisation
EU/1/11/707/003
MA holder
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Relabeled for use in clinical trial

Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion

PRD3445553 · Product

Active substance
Docetaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Authorisation status
Authorised
ATC code
L01CD02 — DOCETAXEL
Marketing authorisation
EU/1/12/769/002
MA holder
ACCORD HEALTHCARE S.L.U.
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Relabeled for use in clinical trial

Avastin 25 mg/ml concentrate for solution for infusion.

PRD2153902 · Product

Active substance
Bevacizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Authorisation status
Authorised
ATC code
L01FG01 — -
Marketing authorisation
EU/1/04/300/002
MA holder
ROCHE REGISTRATION GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Relabeled for clinical trials

Tecentriq

PRD5674603 · Product

Active substance
Atezolizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Authorisation status
Not Authorised
MA holder
ROCHE REGISTRATION LTD.
Paediatric formulation
No
Orphan designation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

213 Total trials 63 Recruiting 141 Ended
Commercial
Sponsor organisation
F. Hoffmann-La Roche AG
Address
Grenzacherstrasse 124
City
Basel
Postcode
4058
Country
Switzerland

Scientific contact point

Organisation
F. Hoffmann-La Roche AG
Contact name
Trial Information System - TISL

Public contact point

Organisation
F. Hoffmann-La Roche AG
Contact name
Trial Information System - TISL

Third parties 7

OrganisationCity, countryDuties
Precision For Medicine Inc.
ORG-100041895
 Frederick, United States Laboratory analysis
Almac Clinical Technologies LLC
ORG-100043036
 Souderton, United States Other
Foundation Medicine Inc.
ORG-100040457
 Cambridge, United States Laboratory analysis
CellCarta
ORG-100039881
 Antwerp, Belgium Laboratory analysis
Discovery Life Sciences Biomarker Services GmbH
ORG-100042520
 Kassel, Germany Laboratory analysis
Fortrea Inc.
ORG-100012602
 Princeton, United States Other
Labcorp Central Laboratory Services SARL
ORG-100011524
 Meyrin, Switzerland Laboratory analysis

Locations

2 EU/EEA countries · 13 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ended 86 6
Spain Ended 63 7
Rest of world
United States, Israel, Taiwan, Australia, United Kingdom, Korea, Republic of
 — 165 —

Investigational sites

France

6 sites · Ended
Institut De Cancerologie De L Ouest
Medical Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre Hospitalier Regional De Marseille
Multidisciplinary oncology and therapeutic innovations, 264 Rue Saint Pierre, 13005, Marseille
Institut Regional Du Cancer De Montpellier
Pulmonology and Thoracic oncology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Centre Hospitalier Universitaire De Bordeaux
Medical Oncology, 1 Rue Jean Burguet, 33000, Bordeaux
Institut Universitaire Du Cancer Toulouse-Oncopole
Pulmonology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centr Georges Francois Leclerc
Medical Oncology, 1 Rue Professeur Marion, 21000, Dijon

Spain

7 sites · Ended
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Clinica Universidad De Navarra
Oncology, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario La Paz
Oncology, Paseo De La Castellana 261, 28046, Madrid

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 2018-06-22 2025-11-25 2018-12-14 2024-10-31
Spain 2018-05-10 2025-04-02 2018-05-29 2024-10-31

Results and documents

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

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
BO39610_Summary of Results
SUM-125369
 2026-03-25T13:33:25 Submitted Summary of Results

Documents 7 files

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

TypeTitleVersion
Protocol (for publication) D1_Protocol 2023-504038-23-00 Redacted.pdf 21
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Docetaxel Accord 80 mg4 ml concentrate for solution for infusion.pdf NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Trajenta NA
Summary of results (for publication) BO39610 CTIS Results Summary 23 March 2026 NA
Synopsis of the protocol (for publication) D1_Protocol synopsis_ENG 2023-504038-23-00.pdf 1.0
Synopsis of the protocol (for publication) d1_protocol-synopsis_es-2023-504038-23-00 1.0
Synopsis of the protocol (for publication) d1_protocol-synopsis_fr-2023-504038-23-00 1.0

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-06-03 Spain Acceptable
2024-06-27
 2024-06-27
2 SUBSTANTIAL MODIFICATION SM-1 2024-11-11 Spain Acceptable
2025-01-21
 2025-01-21
3 NON SUBSTANTIAL MODIFICATION NSM-1 2025-02-14 Spain Acceptable
2025-01-21
 2025-02-14

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