Trial Title:
Volrustomig Priming Regimens Exploratory Phase II Platform Study
NCT ID:
NCT06448754
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pemetrexed
Conditions: Keywords:
Solid Tumor
Programmed cell death-ligand-1
Tumor proportion score
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Volrustomig
Description:
Participants will receive volrustomig via intravenous (IV) infusion.
Arm group label:
Arm 1 B Volrustomig dose regimen 2 + Carboplatin and Pemetrexed
Arm group label:
Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed
Other name:
MEDI5752
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Participants will receive carboplatin via IV infusion.
Arm group label:
Arm 1 B Volrustomig dose regimen 2 + Carboplatin and Pemetrexed
Arm group label:
Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Participants will receive pemetrexed via IV infusion.
Arm group label:
Arm 1 B Volrustomig dose regimen 2 + Carboplatin and Pemetrexed
Arm group label:
Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed
Summary:
Purpose of this study is to assess the safety, tolerability, pharmacokinetics,
immunogenicity, and antitumor activity of volrustomig in combination with other
anticancer drugs in participants with specified solid tumors.
Detailed description:
This is a platform, randomized, open-label, multicenter, global study.
Enrolled participants with Stage IV non-squamous non-small cell lung cancer (NSQ NSCLC)
who are treatment-naïve and have not received previous treatment for advanced or
metastatic disease.
These participants will be randomized in a 1:1 ratio to one of the two treatment arms:
Arm 1A and Arm 1B.
Both arms will test a volrustomig dosing in combination with chemotherapy.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no
deterioration.
- Life expectancy greater than or equal to (>=) 12 weeks.
- Adequate organ and bone marrow function.
- Body weight greater than (>) 35 kilograms (kg) at screening and at randomization.
- Histologically or cytologically documented NSQ NSCLC.
- Absence of sensitizing epidermal growth factor receptor (EGFR) mutations.
- Absence of documented tumor genomic alteration 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.
- At least one measurable lesion not previously irradiated that can be accurately
measured at baseline as >= 10 millimeter (mm) in the longest diameter.
Key Exclusion Criteria:
- Spinal cord compression.
- History of primary active immunodeficiency.
- Active or prior documented autoimmune or inflammatory disorders.
- Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant.
- Brain metastases unless asymptomatic, stable, and not requiring steroids for at
least 14 days prior to start of study intervention. A minimum of 2 weeks must have
elapsed between the end of radiation therapy and study enrollment.
- Prior chemotherapy or any other systemic therapy for Stage IV NSCLC. Participants
who have received prior platinum-containing adjuvant, neoadjuvant, or definitive
chemoradiation for advanced disease are eligible, provided that progression has
occurred greater (>) 12 months from end of last therapy.
Gender:
All
Minimum age:
18 Years
Maximum age:
130 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Los Angeles
Zip:
90067
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Grand Junction
Zip:
81501
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Wheat Ridge
Zip:
80033
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Baltimore
Zip:
21231
Country:
United States
Status:
Suspended
Facility:
Name:
Research Site
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Suspended
Facility:
Name:
Research Site
Address:
City:
Chapel Hill
Zip:
27514
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Tacoma
Zip:
98405
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Montreal
Zip:
H4A 3J1
Country:
Canada
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hangzhou
Zip:
310014
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Jinan
Zip:
250013
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Yantai
Zip:
264000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Zhengzhou City
Zip:
450000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Bois Guillaume
Zip:
76031
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Caen Cedex
Zip:
14076
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Créteil
Zip:
94000
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Dijon
Zip:
21079
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Montpellier
Zip:
34070
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Batumi
Zip:
6010
Country:
Georgia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tbilisi
Zip:
'0159
Country:
Georgia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tbilisi
Zip:
0112
Country:
Georgia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tbilisi
Zip:
0114
Country:
Georgia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tbilisi
Zip:
0144
Country:
Georgia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Genoa
Zip:
16132
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Orbassano
Zip:
10043
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Perugia
Zip:
06132
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Udine
Zip:
33100
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Verona
Zip:
37134
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seongnam
Zip:
13620
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Suwon
Zip:
16247
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kuala Lumpur
Zip:
59100
Country:
Malaysia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kuching
Zip:
93586
Country:
Malaysia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Lisboa
Zip:
1169-050
Country:
Portugal
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Lisboa
Zip:
1649-035
Country:
Portugal
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Porto
Zip:
4099-001
Country:
Portugal
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Porto
Zip:
4100-180
Country:
Portugal
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kragujevac
Zip:
34000
Country:
Serbia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Alcorcón
Zip:
28922
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
08041
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
La Coruna
Zip:
15006
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Málaga
Zip:
29004
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Santiago de Compostela
Zip:
15706
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Valencia
Zip:
46015
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Genève 14
Zip:
1205
Country:
Switzerland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Lausanne
Zip:
1011
Country:
Switzerland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Winterthur
Zip:
8401
Country:
Switzerland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Zürich
Zip:
8091
Country:
Switzerland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Changhua City
Zip:
50006
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
New Taipei
Zip:
23561
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei City
Zip:
110
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
106
Country:
Taiwan
Status:
Not yet recruiting
Start date:
August 27, 2024
Completion date:
December 8, 2026
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06448754
