Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors
NCT ID: NCT03509012
Last Updated: 2025-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
105 participants
INTERVENTIONAL
2018-05-02
2025-01-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HNSCC Arm 1
Durvalumab + cisplatin with radiation in patients with locally advanced squamous cell carcinoma of the head and neck (HNSCC)
Durvalumab
IV (intravenous)
Cisplatin (dose level 4)
IV
External beam radiation (dose level 1)
radiation therapy
NSCLC Arm 1
Durvalumab + cisplatin and etoposide with radiation in patients with locally advanced, unresectable (Stage III) non-small-cell lung cancer (NSCLC)
Durvalumab
IV (intravenous)
Etoposide (dose level 1)
IV
External beam radiation (dose level 2)
radiation therapy
Cisplatin (dose level 1)
IV
NSCLC Arm 2
Durvalumab + carboplatin and paclitaxel with radiation in patients with locally advanced, unresectable (Stage III) non-small-cell lung cancer (NSCLC)
Durvalumab
IV (intravenous)
Carboplatin (dose level 1)
IV
Paclitaxel
IV
External beam radiation (dose level 2)
radiation therapy
NSCLC Arm 3
Investigator's choice of carboplatin and pemetrexed OR cisplatin and pemetrexed
Durvalumab
IV (intravenous)
Carboplatin (dose level 2)
IV
Pemetrexed
IV
External beam radiation (dose level 2)
radiation therapy
Cisplatin (dose level 2)
IV
SCLC Arm 1
Patients should start with cisplatin, but if cisplatin is not tolerated, they have the option to switch to carboplatin
Durvalumab
IV (intravenous)
Cisplatin (dose level 3)
IV
Carboplatin (dose level 2)
IV
Etoposide (dose level 2)
IV
External beam radiation (standard)
radiation therapy
SCLC Arm 2
Patients with limited-stage small-cell lung cancer (SCLC) should start with cisplatin, but if cisplatin is not tolerated, they have the option to switch to carboplatin
Durvalumab
IV (intravenous)
Cisplatin (dose level 3)
IV
Carboplatin (dose level 2)
IV
Etoposide (dose level 2)
IV
External beam radiation (hyperfractionated)
radiation therapy
SCLC Arm 3
Patients should start with cisplatin, but if cisplatin is not tolerated, they have the option to switch to carboplatin. Note: Arm 3 will only be opened if the regimen in SCLC Arm 1 is safe and tolerable.
Durvalumab
IV (intravenous)
Tremelimumab
IV
Cisplatin (dose level 3)
IV
Carboplatin (dose level 2)
IV
Etoposide (dose level 2)
IV
External beam radiation (standard)
radiation therapy
SCLC Arm 4
Patients should start with cisplatin, but if cisplatin is not tolerated, they have the option to switch to carboplatin Note: Arm 4 will only be opened if the regimen in SCLC Arm 2 is safe and tolerable.
Durvalumab
IV (intravenous)
Tremelimumab
IV
Cisplatin (dose level 3)
IV
Carboplatin (dose level 2)
IV
Etoposide (dose level 2)
IV
External beam radiation (hyperfractionated)
radiation therapy
Interventions
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Durvalumab
IV (intravenous)
Tremelimumab
IV
Cisplatin (dose level 4)
IV
Cisplatin (dose level 3)
IV
Carboplatin (dose level 1)
IV
Carboplatin (dose level 2)
IV
Etoposide (dose level 1)
IV
Etoposide (dose level 2)
IV
Paclitaxel
IV
Pemetrexed
IV
External beam radiation (dose level 1)
radiation therapy
External beam radiation (dose level 2)
radiation therapy
External beam radiation (hyperfractionated)
radiation therapy
Cisplatin (dose level 1)
IV
Cisplatin (dose level 2)
IV
External beam radiation (standard)
radiation therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body weight \>30 kg at enrollment and treatment assignment
* At least 1 measurable lesion, not previously irradiated
* No prior exposure to immune-mediated therapy (including therapeutic anticancer vaccines)
* For patients with oropharyngeal HNSCC HPV status has to be known
Exclusion Criteria
* Active or prior documented autoimmune or inflammatory disorders
* Brain metastases or spinal cord compression
* Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV; positive HIV 1/2 antibodies)
* Has a paraneoplastic syndrome (PNS) of autoimmune nature
* HNSCC cohort: Head and neck cancer that does not include unresectable, locally advanced cancer of oral cavity, larynx, oropharynx or hypopharynx. HNSCC of unknown primary are also excluded
* NSCLC and SCLC cohort: Mixed SCLC and NSCLC histology
* SCLC cohort: Extensive-stage SCLC
18 Years
110 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Tucson, Arizona, United States
Research Site
Aurora, Colorado, United States
Research Site
Houston, Texas, United States
Research Site
Kōtoku, , Japan
Research Site
Sunto-gun, , Japan
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Badalona, , Spain
Research Site
Madrid, , Spain
Research Site
Málaga, , Spain
Research Site
Taichung, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan, , Taiwan
Countries
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Other Identifiers
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2017-002242-77
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D933BC00001
Identifier Type: -
Identifier Source: org_study_id
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