Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer
Start Date
4/14/2022
Completion Date
5/28/2030
Summary
The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab, or AZD0171 and platinum doublet chemotherapy (CTX); or Volrustomig or Rilvegostomig in combination with CTX; or Datopotamab deruxtecan (Dato-DXd) in combination with Durvalumab or Rilvegostomig and single agent platinum chemotherapy in participants with resectable, early-stage non-small cell lung cancer.
Detailed Description
This is an open-label, multi-arms, multicentre, randomised study, eligible participants will be enrolled and randomised to one of the following treatment regimens. Arm 1: Participants will receive Oleclumab + durvalumab + CTX as neoadjuvant treatment and Oleclumab + durvalumab as adjuvant treatment. Arm 2: Participants will receive Monalizumab + durvalumab + CTX as neoadjuvant treatment and Monalizumab + durvalumab as adjuvant treatment. Arm 3: Participants will receive Volrustomig (Dose Exploration) + CTX as neoadjuvant treatment and Volrustomig as adjuvant treatment. Arm 4: Participants will receive Dato-DXd + durvalumab + single agent platinum chemotherapy as neoadjuvant treatment and durvalumab as adjuvant treatment. Arm 5: Participants will receive AZD0171 + durvalumab + CTX as neoadjuvant treatment and AZD0171 + durvalumab as adjuvant treatment. Arm 6: Participants will receive Rilvegostomig + CTX as neoadjuvant treatment and Rilvegostomig as adjuvant treatment. Arm 7: Participants will receive Dato-DXd + Rilvegostomig + single agent platinum chemotherapy as neoadjuvant treatment and Rilvegostomig as adjuvant treatment.
Eligibility Criteria
Age Range: 18 years to 95 years
Interventions
Durvalumab
Oleclumab
Monalizumab
Dato-DXd
AZD0171
Carboplatin
Cisplatin
Pemetrexed/Cisplatin
Pemetrexed/Carboplatin
Carboplatin/Paclitaxel
Volrustomig
Rilvegostomig
Conditions
Locations
Research Site
Little Rock, Arkansas 72205
United States
Research Site
Los Angeles, California 90095
United States
Research Site
Oakland, California 94611
United States
Research Site
New Haven, Connecticut 06510
United States
Research Site
Stuart, Florida 34994
United States
Research Site
Gainesville, Georgia 30501
United States
Research Site
Chicago, Illinois 60637
United States
Research Site
Baltimore, Maryland 21201
United States
Research Site
Baltimore, Maryland 21231
United States
Research Site
Boston, Massachusetts 02215
United States
Research Site
Saint Louis Park, Minnesota 55426
United States
Research Site
Omaha, Nebraska 68124
United States
Research Site
Buffalo, New York 14263
United States
Research Site
Cleveland, Ohio 44195
United States
Research Site
Pittsburgh, Pennsylvania 15212
United States
Research Site
Chattanooga, Tennessee 37404
United States
Research Site
Memphis, Tennessee 38120
United States
Research Site
Nashville, Tennessee 37203
United States
Research Site
Nashville, Tennessee 37203
United States
Research Site
Nashville, Tennessee 37232
United States
Research Site
Houston, Texas 77030
United States
Research Site
Houston, Texas 77090
United States
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Fairfax, Virginia 22031
United States
Research Site
Edmonds, Washington 98026
United States
Research Site
Seattle, Washington 98104
United States
Research Site
Ghent, 9000
Belgium
Research Site
Ghent, 9000
Belgium
Research Site
Roeselare, 8800
Belgium
Research Site
Edmonton, Alberta T6G 1Z2
Canada
Research Site
Winnipeg, Manitoba R3E 0V9
Canada
Research Site
Montreal, Quebec H2W 1S6
Canada
Research Site
Montreal, Quebec H2X 3E4
Canada
Research Site
Avignon, 84902
France
Research Site
Bobigny, 93009
France
Research Site
Bordeaux, 33076
France
Research Site
Limoges, 83000
France
Research Site
Rennes, 35000
France
Research Site
Rouen, 76031
France
Research Site
Suresnes, 92150
France
Research Site
Toulon, 83000
France
Research Site
Kecskemét, 6000
Hungary
Research Site
Székesfehérvár, 8000
Hungary
Research Site
Tatabánya, 2800
Hungary
Research Site
Törökbálint, 2045
Hungary
Research Site
Dublin, D07 R2WY
Ireland
Research Site
Dublin, D08 NHY1
Ireland
Research Site
Dublin, D09 V2N0
Ireland
Research Site
Galway, H91 YR71
Ireland
Research Site
Aviano, 33081
Italy
Research Site
Brescia, 25123
Italy
Research Site
Catanzaro, 88100
Italy
Research Site
Florence, 50134
Italy
Research Site
Genova, 16100
Italy
Research Site
Meldola, 47014
Italy
Research Site
Milan, 20162
Italy
Research Site
Monza, 20900
Italy
Research Site
Padova, 35128
Italy
Research Site
Perugia, 06156
Italy
Research Site
Pisa, 56124
Italy
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Roma, 00144
Italy
Research Site
Rozzano, 20089
Italy
Research Site
Lisbon, 1099-023
Portugal
Research Site
Lisbon, 1169-050
Portugal
Research Site
Lisbon, 1400-038
Portugal
Research Site
Lisbon, 1500-650
Portugal
Research Site
Porto, 4099-001
Portugal
Research Site
Porto, 4100-180
Portugal
Research Site
Porto, 4200-072
Portugal
Research Site
Busan, 48108
South Korea
Research Site
Chungcheongbuk-do, 28644
South Korea
Research Site
Seongnam-si, 13496
South Korea
Research Site
Seoul, 03080
South Korea
Research Site
Seoul, 05505
South Korea
Research Site
Suwon, 16247
South Korea
Research Site
Suwon, 440-746
South Korea
Research Site
A Coruña, 15006
Spain
Research Site
Alicante, 03010
Spain
Research Site
Barcelona, 08036
Spain
Research Site
Barcelona, 8035
Spain
Research Site
Córdoba, 14004
Spain
Research Site
Madrid, 28040
Spain
Research Site
Majadahonda, 28250
Spain
Research Site
Málaga, 29010
Spain
Research Site
Reus, 43204
Spain
Research Site
Seville, 41009
Spain
Research Site
Terrassa, 08221
Spain
Research Site
Valencia, 46010
Spain
Research Site
Liuying, 736
Taiwan
Research Site
New Taipei City, 235
Taiwan
Research Site
Tainan, 70403
Taiwan
Research Site
Taipei, 10002
Taiwan
Research Site
Taipei, 11217
Taiwan
Research Site
Ankara, 06010
Turkey (Türkiye)
Research Site
Ankara, 06500
Turkey (Türkiye)
Research Site
Ankara, 06800
Turkey (Türkiye)
Research Site
Istanbul, 34722
Turkey (Türkiye)
Research Site
Izmir, 35575
Turkey (Türkiye)