A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC
Launched by ASTRAZENECA · Jan 26, 2022
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of two medications, durvalumab and domvanalimab, on adults with Stage III non-small cell lung cancer (NSCLC) that cannot be surgically removed. The trial aims to find out if this combination is more effective and safe compared to durvalumab alone after patients have undergone a specific type of treatment known as chemoradiation. To participate, individuals must be at least 18 years old, have a confirmed diagnosis of NSCLC, and have received treatment with chemoradiation without any signs of their cancer getting worse.
If you join this study, you'll be randomly assigned to receive either the combination treatment or just durvalumab with a placebo (a treatment that doesn't contain the active drug). Throughout the trial, participants will be monitored closely for any side effects and how well the treatment is working. It's important to note that there are specific criteria to be eligible, including having a certain type of tumor and not having progressed after previous treatments. This trial is currently recruiting participants, and it could help improve future treatment options for others with similar diagnoses.
Gender
ALL
Eligibility criteria
- INCLUSION CRITERIA:
- • 1. Participant must be ≥ 18 years at the time of screening.
- • 2. Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
- • 3. Provision of a tumour tissue sample obtained prior to CRT
- • 4. Documented tumour PD-L1 status ≥ 1% by central lab
- • 5. Documented EGFR and ALK wild-type status (local or central).
- • 6. Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy
- • 7. Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy
- • 8. Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique.
- • 9. WHO performance status of 0 or 1 at randomization
- • 10. Adequate organ and marrow function
- EXCLUSION CRITERIA:
- 1. History of another primary malignancy, except for:
- • Malignancies treated with curative intent and adequate follow-up with no known active disease and have not required active treatment within the past 3 years before the first dose of study intervention and of low potential risk of recurrence.
- • Adequately resected non melanoma skin cancer or lentigo maligna without evidence of disease .
- • Adequately treated carcinoma in situ, including Ta tumors without evidence of disease.
- • 2. Mixed small cell and non-small cell lung cancer histology.
- • 3. Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
- • 4. Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
- • 5. Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy (excluding alopecia).
- • 6. Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy.
- • 7. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis
- • 8. Active or prior documented autoimmune or inflammatory disorders (with exceptions)
- • 9. Active EBV infection, or known or suspected chronic active EBV infection at screening
- • 10. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Maywood, Illinois, United States
Rochester, Minnesota, United States
Nashville, Tennessee, United States
Fountain Valley, California, United States
Detroit, Michigan, United States
Edegem, , Belgium
Barretos, , Brazil
Székesfehérvár, , Hungary
Marg Jaipur, , India
Białystok, , Poland
Minneapolis, Minnesota, United States
Tainan, , Taiwan
Orlando, Florida, United States
Louisville, Kentucky, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Leuven, , Belgium
Calgary, Alberta, Canada
Lille, , France
Roma, , Italy
Liege, , Belgium
Izmir, , Turkey
Erlangen, , Germany
Basel, , Switzerland
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Mesa, Arizona, United States
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Johnson City, New York, United States
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Udine, , Italy
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Aguascalientes, , Mexico
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München, , Germany
Athens, , Greece
Brighton, , United Kingdom
Cambridge, , United Kingdom
Wroclaw, , Poland
Nottingham, , United Kingdom
Baltimore, Maryland, United States
Columbus, Ohio, United States
Chandler, Arizona, United States
Quezon City, , Philippines
Giessen, , Germany
Montreal, Quebec, Canada
Deszk, , Hungary
Taichung, , Taiwan
Löwenstein, , Germany
Budapest, , Hungary
Törökbálint, , Hungary
Essen, , Germany
Barnaul, , Russian Federation
Jacksonville, Florida, United States
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Regensburg, , Germany
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Santa Rosa, California, United States
Oklahoma City, Oklahoma, United States
Beijing, , China
Chongqing, , China
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Craiova, , Romania
Taichung, , Taiwan
Rozzano, , Italy
Chihuahua, , Mexico
Perm, , Russian Federation
Laval, Quebec, Canada
Kazan, , Russian Federation
Birmingham, , United Kingdom
Nizhny Novgorod, , Russian Federation
Cardiff, , United Kingdom
Elmhurst, Illinois, United States
Nagoya Shi, , Japan
Sapporo Shi, , Japan
Iloilo City, , Philippines
Taipei, , Taiwan
Kelowna, British Columbia, Canada
Truro, , United Kingdom
Lausanne, , Switzerland
Matsuyama Shi, , Japan
Floresti, , Romania
Reno, Nevada, United States
Guangzhou, , China
Hangzhou, , China
Yinchuan, , China
Kuala Lumpur, , Malaysia
Kuching, , Malaysia
Parktown, , South Africa
Koto Ku, , Japan
Spokane Valley, Washington, United States
Tokyo, , Japan
Berlin, , Germany
Sunto Gun, , Japan
Fort Sam Houston, Texas, United States
Tübingen, , Germany
Shandong, , China
El Palmar, , Spain
Aix En Provence, , France
Kingwood, Texas, United States
Macon, Georgia, United States
Chengdu, , China
Shanghai, , China
Taiyuan, , China
Xi'an, , China
Hamburg, , Germany
Washington, District Of Columbia, United States
Kumamoto Shi, , Japan
Tomsk, , Russian Federation
Cape Town, , South Africa
Chiba Shi, , Japan
Monterrey, , Mexico
Thessaloniki, , Greece
Oslo, , Norway
Thessaloniki, , Greece
Phoenix, Arizona, United States
Villeurbanne, , France
Bergamo, , Italy
Clermont Ferrand, , France
Seoul, , Korea, Republic Of
Veracruz, , Mexico
Bacolod, , Philippines
Pasig City, , Philippines
Antalya, , Turkey
Hanoi, , Vietnam
Ho Chi Minh City, , Vietnam
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Ho Chi Minh, , Vietnam
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Konya, , Turkey
Iasi, , Romania
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Daegu, , Korea, Republic Of
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Bern, , Switzerland
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Chemnitz, , Germany
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Goyang Si, , Korea, Republic Of
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Istanbul, , Turkey
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Pretoria, , South Africa
Pau Cedex, , France
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Suwon, , Korea, Republic Of
Amanzimtoti, , South Africa
Changsha, , China
Incheon, , Korea, Republic Of
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Bangkok, , Thailand
Thessaloniki, , Greece
Bilbao (Vizcaya), , Spain
Suzhou, , China
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Osakasayama Shi, , Japan
Hefei, , China
Köln, , Germany
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Rio De Janeiro, , Brazil
Santo Andre, , Brazil
Florham Park, New Jersey, United States
Fort Belvoir, Virginia, United States
Hong Kong, , Hong Kong
Xiamen, , China
Holargos, Athens, , Greece
Hirosaki Shi, , Japan
Guadalajara, , Mexico
Cordoba, , Spain
Santiago, , Chile
Gurgaon, , India
Ningbo, , China
Bangalore, , India
Haine Saint Paul, , Belgium
Paris Cedex 14, , France
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Kashihara Shi, , Japan
Foshan, , China
Hangzhou, , China
Saint Quentin Cedex, , France
Johor Bahru, , Malaysia
Itabashi Ku, , Japan
New Delhi, , India
Zielona Góra, , Poland
Gyeongsangnam Do, , Korea, Republic Of
Kolkata, , India
Selangor, , Malaysia
Moscow, , Russian Federation
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Dongguan, , China
Hyderabad, , India
Jaipur, , India
Tianjin, , China
Krefeld, , Germany
Qingdao, , China
Temuco, , Chile
Londrina, , Brazil
Dalian, , China
Bangalore, , India
Vantoux, , France
Georgsmarienhuette, , Germany
Namakkal, , India
Muntinlupa City, , Philippines
Baoding, , China
Jinan, , China
Johannesburg, , South Africa
Delhi, , India
Castello De La Plana, , Spain
Las Condes, , Chile
Rohini, , India
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Gliwice, , Poland
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Trondheim, , Norway
Saint Petersburg, , Russian Federation
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High Heaton/Newcastle Upon Tyn, , United Kingdom
Braunschweig, , Germany
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Taubaté, , Brazil
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Ahmedabad, , India
Gjøvik, , Norway
Varanasi, , India
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Appleton, Wisconsin, United States
Craiova, , Romania
Quimper, , France
San Pedro Garza Garcia, , Mexico
Oslo, , Norway
Chihuahua, , Mexico
Patients applied
Trial Officials
Hidehito Horinouchi, MD, PhD
Principal Investigator
National Cancer Center Hospital
Alexander Spira, MD, PhD
Principal Investigator
Virginia Cancer Specialists Research Institute
Jinming Yu, MD, PhD
Principal Investigator
Shandong Cancer Hospital and Institute
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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