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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001748-74 | EudraCT Number |
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This study is designed to determine the efficacy and safety of durvalumab and/or novel oncology therapies, with or without chemotherapy, for first-line Stage IV Non-Small Cell Lung Cancer (NSCLC)
This is a Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of Durvalumab and/or Novel Oncology Therapies, With or Without Chemotherapy, for First-Line Stage IV Non-Small Cell Lung Cancer (NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental | Durvalumab |
|
| A2 | Experimental | Durvalumab + danvatirsen |
|
| A3 | Experimental | Durvalumab + oleclumab |
|
| A4 | Experimental | MEDI5752 |
|
| B1 | Experimental | Durvalumab + Investigator's choice of chemotherapy |
|
| B2 | Experimental | Durvalumab + Investigator's choice of chemotherapy + danvatirsen |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab | Drug | Durvalumab IV Cohort A: Every 4 weeks (q4w) Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of AEs by CTCAE v5.0 | Assessment of safety and tolerability of each treatment arm | From informed consent until the safety follow-up visit 3 months after the last dose of study drug, or until the final data cut-off (DCO) date, whichever is earlier. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Assessment of the efficacy of each treatment arm according to RECIST 1.1. ORR: The percentage of evaluable patients with a confirmed Investigator-assessed visit response of CR or PR | Tumor assessments every 6-9 weeks until week 48-54, then every 12 or 18 weeks, depending on treatment arm until the earliest of radiological progression, death, withdrawal of consent, or final DCO (approximately 4 months after last patient randomized). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandip Patel, MD | UCSD Morres Cancer Center | Principal Investigator |
| Chih-Hsin Yang, MD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Iowa City | Iowa | 52242 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41380462 | Derived | Cho BC, Charoentum C, Kim DW, Yang CT, Dziadziuszko R, Geater SL, Mann H, Afshar-Imani B, Lyfar P, Yang JC, Patel SP. MAGELLAN arms B1 and B3: Durvalumab plus chemotherapy with and without oleclumab in treatment-naive metastatic non-small-cell lung cancer. Lung Cancer. 2026 Jan;211:108834. doi: 10.1016/j.lungcan.2025.108834. Epub 2025 Nov 7. |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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.
Treatment arms for MEDI5752 (Arms A4 and B4) will enroll 42 and 60 patients, respectively. Arm B5 (AZD2936+chemotherapy) will enroll 60 patients.
For all other treatment arms, 30 patients will be enrolled into each arm; additional patients may be enrolled in order to have 30 evaluable patients per arm (ie, dosed).
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| B3 | Experimental | Durvalumab + investigator's choice of chemotherapy + oleclumab |
|
| B4 | Experimental | MEDI5752 |
|
| A5 | Experimental | AZD2936 |
|
| B5 | Experimental | AZD2936 + chemotherapy |
|
|
| Danvatirsen | Drug | Danvatirsen IV Loading dose Cycle 1 Day 1, Cycle 1 Day 3, and Cycle 1 Day 5 then once a week (q1w) starting at Cycle 1 Day 8 |
|
|
| Oleclumab | Drug | Oleclumab IV Cohort A: Every 2 weeks (q2w) for first 2 cycles, then every 4 weeks (q4w) starting at Cycle 3 Day 1 Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1 |
|
|
| MEDI5752 | Drug | MEDI5752 IV Every 3 weeks (q3w) |
|
| Pemetrexed | Drug | Pemetrexed IV Day 1 of each 21-day cycle Arm B1: Day 1 of each 21-day cycle for the first 4 cycles then either every 3 weeks (q3w) or every 4 weeks (q4w) (per investigator discretion) thereafter Arm B2 and B3: Day 1 of each 21-day cycle for the first 4 cycles then Day 1 of each 28-day cycle (q4w) thereafter Arm B5: Day 1 of each 21-day cycle throughout the study |
|
| Carboplatin | Drug | Carboplatin IV Day 1 of each 21-day cycle |
|
| Gemcitabine | Drug | Gemcitabine IV Days 1 and 8 of each 21-day cycle |
|
| Cisplatin | Drug | Cisplatin IV Day 1 of each 21-day cycle |
|
| Nab-paclitaxel | Drug | Nab-paclitaxel IV Days 1, 8, and 15 of each 21-day cycle |
|
| AZD2936 | Drug | AZD2936 IV |
|
| Duration of Response (DoR) | Assessment of the efficacy of each treatment arm according to RECIST 1.1. DoR: Time from date of first detection of objective response until the date of objective radiological disease progression | Tumor assessments every 6-9 weeks until week 48-54, then every 12 or 18 weeks, depending on treatment arm until the earliest of radiological progression, death, withdrawal of consent, or final DCO (approximately 4 months after last patient randomized). |
| Progression Free Survival (PFS) | Assessment of the efficacy of each treatment arm according to RECIST 1.1. PFS: Time from date of treatment assignment until the date of objective radiological disease progression using RECIST 1.1 or death (by any cause in the absence of progression) | Tumor assessments every 6-9 weeks until week 48-54, then every 12/18 weeks based on arm until progression, death, withdrawal or final DCO. Further PFS data will be collected until 6 months after last patient dosed or final DCO |
| Overall Survival (OS) | OS: Time from date of treatment assignment until the date of death by any cause | OS data will be collected until death, 6 months after last patient dosed, or the final DCO date, whichever is earlier. |
| Blood concentration of durvalumab and novel oncology therapies | Drug concentration of durvalumab and novel oncology therapies | From Cycle 1 Day 1 until Cycle 6/7 Day 1 (21-28-day cycles) depending on arm, then every 3 cycles (except for Arms A5 & B5), at end of treatment (Arms A4 & B4, A5 & B5 only), and until 3 months following treatment discontinuation, or the final DCO date. |
| Frequency of anti-drug antibodies (ADAs) for durvalumab and applicable novel oncology therapies | Investigation of the immunogenicity of durvalumab and each applicable novel oncology therapy in all applicable treatment arms | From Cycle 1 Day 1 until Cycle 6/7 Day 1 (21-28-day cycles) depending on arm, then every 3 or 6 cycles (except for arms A5&B5), at end of treatment (arms A4&B4, A5&B5 only), until 3/6 months after treatment discontinuation, or the final DCO date. |
| Pittsburgh |
| Pennsylvania |
| 15212 |
| United States |
| Research Site | Nashville | Tennessee | 37203 | United States |
| Research Site | Salzburg | 5020 | Austria |
| Research Site | Vienna | 1140 | Austria |
| Research Site | Edegem | 2650 | Belgium |
| Research Site | Bialystok | 15-027 | Poland |
| Research Site | Bydgoszcz | 85-796 | Poland |
| Research Site | Gdansk | 80-214 | Poland |
| Research Site | Grudziądz | 86-300 | Poland |
| Research Site | Lodz | 90-302 | Poland |
| Research Site | Olsztyn | 10-357 | Poland |
| Research Site | Tomaszów Mazowiecki | 97-200 | Poland |
| Research Site | Warsaw | 02-781 | Poland |
| Research Site | Wroclaw | 53-413 | Poland |
| Research Site | Krasnoyarsk | 660133 | Russia |
| Research Site | Moscow | 115478 | Russia |
| Research Site | Saint Petersburg | 191014 | Russia |
| Research Site | Saint Petersburg | 197758 | Russia |
| Research Site | Cheongju-si | 28644 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Seoul | 06351 | South Korea |
| Research Site | Seoul | 110-744 | South Korea |
| Research Site | Barcelona | 08025 | Spain |
| Research Site | Barcelona | 8003 | Spain |
| Research Site | Madrid | 28034 | Spain |
| Research Site | Madrid | 28041 | Spain |
| Research Site | Seville | 41013 | Spain |
| Research Site | Kaohsiung City | 807 | Taiwan |
| Research Site | Taichung | 402 | Taiwan |
| Research Site | Taichung | 40705 | Taiwan |
| Research Site | Tainan | 70403 | Taiwan |
| Research Site | Taipei | 10002 | Taiwan |
| Research Site | Taipei | 112 | Taiwan |
| Research Site | Taipei | 235 | Taiwan |
| Research Site | Taoyuan | 333 | Taiwan |
| Research Site | Bangkok | 10330 | Thailand |
| Research Site | Bangkok | 10700 | Thailand |
| Research Site | Chiang Mai | 50200 | Thailand |
| Research Site | Hat Yai | 90110 | Thailand |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000613593 | durvalumab |
| C000610954 | danvatirsen |
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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