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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06627647




Registration number
NCT06627647
Ethics application status
Date submitted
3/10/2024
Date registered
4/10/2024
Date last updated
7/05/2025

Titles & IDs
Public title
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC
Scientific title
A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)
Secondary ID [1] 0 0
2024-515008-38-00
Secondary ID [2] 0 0
D702FC00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-squamous Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rilvegostomig
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Pemetrexed

Experimental: Arm A - Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.

Active comparator: Arm B - Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.


Treatment: Drugs: Rilvegostomig
Administered as one intravenously (IV) on Day 1 of each 21-day cycle

Treatment: Drugs: Pembrolizumab
Administered as one intravenously (IV) on Day 1 of each 21-day cycle

Treatment: Drugs: Carboplatin
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

Treatment: Drugs: Cisplatin
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

Treatment: Drugs: Pemetrexed
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
Up to approximately 5 years
Primary outcome [2] 0 0
Progression-free survival (PFS)
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Landmark overall survival (OS) rates
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
Landmark progression-free survival (PFS) rates
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [3] 0 0
Time to second progression or death (PFS2)
Timepoint [3] 0 0
Up to approximately 5 years
Secondary outcome [4] 0 0
Overall response rate (ORR)
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
Duration of response (DoR)
Timepoint [5] 0 0
Up to approximately 5 years
Secondary outcome [6] 0 0
Pharmacokinetic (PK) of rilvegostomig
Timepoint [6] 0 0
Up to approximately 5 years
Secondary outcome [7] 0 0
Immunogenicity of rilvegostomig
Timepoint [7] 0 0
Up to approximately 5 years
Secondary outcome [8] 0 0
Patient-reported physical functioning
Timepoint [8] 0 0
Up to approximately 5 years
Secondary outcome [9] 0 0
Patient-reported global health status (GHS)/quality of life (QoL)
Timepoint [9] 0 0
Up to approximately 5 years
Secondary outcome [10] 0 0
Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)
Timepoint [10] 0 0
Up to approximately 5 years

Eligibility
Key inclusion criteria
* Histologically or cytologically documented non-squamous NSCLC.
* Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
* Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements.
* Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L therapies.
* Provision of acceptable tumor sample, to confirm tumor PD-L1 expression TC = 1%.
* At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as = 10 mm in the longest diameter (except lymph nodes, which must have short axis = 15 mm) with CT or MRI and is suitable for accurate repeated measurements.
* Adequate organ and bone marrow function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Presence of small cell and neuroendocrine histology components.
* Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization.
* Any prior systemic therapy received for advanced or mNSCLC. Prior systemic therapy in the neoadjuvant or adjuvant setting and/or definitive radio- or chemoradiotherapy for early-stage disease are allowed, provided that recurrence or progression has occurred > 12 months after the end of treatment.
* Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
* Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease = 2 years before the first dose of study intervention and of low potential risk for recurrence.
* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
* Active primary immunodeficiency/active infectious disease(s).
* Active tuberculosis infection.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/03/2030
Actual
Sample size
Target
878
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Darlinghurst
Recruitment hospital [2] 0 0
Research Site - Hyde Park
Recruitment hospital [3] 0 0
Research Site - Southport
Recruitment hospital [4] 0 0
Research Site - Wollongong
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4812 - Hyde Park
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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California
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Colorado
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Connecticut
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Delaware
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Florida
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Georgia
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Idaho
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Illinois
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Iowa
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Kentucky
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Louisiana
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Michigan
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Minnesota
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Missouri
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Nebraska
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New Jersey
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New York
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Ohio
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Oregon
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New Brunswick
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Nova Scotia
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Giessen
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Hemer
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München
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Würzburg
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Hungary
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Budapest
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Debrecen
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Gyöngyös
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Gyor
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Pécs
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Székesfehérvár
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Törökbálint
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India
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Calicut
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India
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Kolkata
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India
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Madurai
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India
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Mumbai
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India
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Nashik
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India
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New Delhi
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India
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Varanasi
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Italy
State/province [117] 0 0
Firenze
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Italy
State/province [118] 0 0
Monza
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Italy
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Peschiera Del Garda
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Italy
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Rome
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Japan
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Amagasaki-shi
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Japan
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Bunkyo-ku
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Japan
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Chuo-ku
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Japan
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Fukuoka-shi
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Japan
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Hiroshima-shi
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Japan
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Kawagoe-shi
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Japan
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Kitaadachi-gun
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Kobe-shi
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Koto-ku
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Kumamoto-shi
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Osaka-shi
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Ota-shi
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Saitama-shi
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Sendai-shi
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Shinjuku-ku
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Japan
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Sunto-gun
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Japan
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Yokohama-shi
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Korea, Republic of
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Songpa-gu
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuching
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Groningen
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Leidschendam
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Veldhoven
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Peru
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Lima
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Biala Podlaska
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Bialystok
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Bydgoszcz
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Bystra
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Warszawa
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Lódz
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Puerto Rico
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San Juan
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Barcelona
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Sevilla
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Kaohsiung
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New Taipei City
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Taiwan
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Taichung
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Tainan
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Taoyuan City
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Dusit
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Thailand
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Nakhon Ratchasima
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Thailand
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Songkla
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Turkey
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Ankara
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Antalya
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Edirne
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Turkey
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Izmir
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Turkey
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Seyhan
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United Kingdom
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Aberdeen
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United Kingdom
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Cambridge
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United Kingdom
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Edinburgh
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United Kingdom
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Exeter
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United Kingdom
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Greater London
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United Kingdom
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London
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United Kingdom
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Manchester
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Newcastle upon Tyne
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Torquay
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Can Tho
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Hanoi
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Vietnam
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Ho Chi Minh City
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Vietnam
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Ho Chi Minh
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Vietnam
State/province [193] 0 0
Vinh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06627647