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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002242-77 | EudraCT Number |
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This is an open-label, multicenter, phase I study to evaluate the safety and tolerability of durvalumab ± tremelimumab in combination with chemoradiation in patients with advanced solid tumors
This study will initially treat up to approximately 300 patients with advanced solid tumors at approximately 30 sites, worldwide. The study will be composed of a dose-limiting toxicity (DLT) assessment phase (Part A) and an expansion phase (Part B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HNSCC Arm 1 | Experimental | Durvalumab + cisplatin with radiation in patients with locally advanced squamous cell carcinoma of the head and neck (HNSCC) |
|
| NSCLC Arm 1 | Experimental | Durvalumab + cisplatin and etoposide with radiation in patients with locally advanced, unresectable (Stage III) non-small-cell lung cancer (NSCLC) |
|
| NSCLC Arm 2 | Experimental | Durvalumab + carboplatin and paclitaxel with radiation in patients with locally advanced, unresectable (Stage III) non-small-cell lung cancer (NSCLC) |
|
| NSCLC Arm 3 | Experimental | Investigator's choice of carboplatin and pemetrexed OR cisplatin and pemetrexed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab | Drug | IV (intravenous) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Dose Limiting Toxicities (DLTs) | From first dose of durvalumab until 28 days after completion of radiation therapy | |
| Number of subjects with Adverse Events (AEs) | From first dose of durvalumab up to 90 days after the last dose of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | From first dose until the date of objective disease progression or death, in the absence of progression at 12, 18 and 24 months, up to 4 years. | |
| Overall Survival (OS) | From first dose until death due to any cause through study completion, up to 4 years |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tucson | Arizona | 85719 | United States | ||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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| SCLC Arm 1 |
| Experimental |
Patients should start with cisplatin, but if cisplatin is not tolerated, they have the option to switch to carboplatin |
|
| SCLC Arm 2 | Experimental | 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 |
|
| SCLC Arm 3 | Experimental | 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. |
|
| SCLC Arm 4 | Experimental | 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. |
|
|
| Tremelimumab | Drug | IV |
|
| Cisplatin (dose level 4) | Drug | IV |
|
| Cisplatin (dose level 3) | Drug | IV |
|
| Carboplatin (dose level 1) | Drug | IV |
|
| Carboplatin (dose level 2) | Drug | IV |
|
| Etoposide (dose level 1) | Drug | IV |
|
| Etoposide (dose level 2) | Drug | IV |
|
| Paclitaxel | Drug | IV |
|
| Pemetrexed | Drug | IV |
|
| External beam radiation (dose level 1) | Radiation | radiation therapy |
|
| External beam radiation (dose level 2) | Radiation | radiation therapy |
|
| External beam radiation (hyperfractionated) | Radiation | radiation therapy |
|
| Cisplatin (dose level 1) | Drug | IV |
|
| Cisplatin (dose level 2) | Drug | IV |
|
| External beam radiation (standard) | Radiation | radiation therapy |
|
| Objective response rate (ORR) | Number (%) of patients with an overall response of complete response (CR) or partial response (PR). | From first dose until disease progression, or the last evaluable assessment in the absence of progression, assessed up to 4 years. |
| Best objective response (BoR) | The best response based on the overall visit responses from each RECIST 1.1 assessment or the last evaluable assessment in the absence of RECIST 1.1 progression. | From first dose until disease progression, or the last evaluable assessment in the absence of progression, assessed up to 4 years. |
| Duration of response (DoR) | Time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. | From first dose until disease progression, or death, in the absence of progression, assessed up to 4 years. |
| Disease control rate (DCR) | From first dose until disease progression, at 18 weeks and 48 weeks. |
| Disease-free survival (DFS) | From first dose until disease progression or death, in the absence of progression at 12, 18 and 24 months, assessed up to 4 years. |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Research Site | Houston | Texas | 77090 | United States |
| Research Site | Kōtoku | 135-8550 | Japan |
| Research Site | Sunto-gun | 411-8777 | Japan |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Seoul | 06351 | South Korea |
| Research Site | Badalona | 08916 | Spain |
| Research Site | Madrid | 28007 | Spain |
| Research Site | Málaga | 29010 | Spain |
| Research Site | Taichung | 40705 | Taiwan |
| Research Site | Taipei | 10002 | Taiwan |
| Research Site | Taipei | 112 | Taiwan |
| Research Site | Taoyuan City | 333 | Taiwan |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000613593 | durvalumab |
| C520704 | tremelimumab |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| D017239 | Paclitaxel |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
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