A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC (MAGELLAN)
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| ClinicalTrials.gov Identifier: NCT03819465 |
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Recruitment Status :
Recruiting
First Posted : January 28, 2019
Last Update Posted : February 26, 2021
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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Brief Summary:
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)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic Non-Small Cell Lung Cancer (NSCLC) | Drug: Durvalumab Drug: Danvatirsen Drug: Oleclumab Drug: MEDI5752 Drug: Pemetrexed Drug: Carboplatin Drug: Gemcitabine Drug: Cisplatin Drug: Nab-paclitaxel | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 212 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Treatment arms for MEDI5752 (Arms A4 and B4) will enroll 42 and 60 patients, respectively. Thirty patients will be enrolled into each remaining arm; additional patients may be enrolled in order to have 30 evaluable patients per arm (ie, dosed). |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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) (MAGELLAN) |
| Actual Study Start Date : | December 27, 2018 |
| Estimated Primary Completion Date : | October 25, 2023 |
| Estimated Study Completion Date : | October 25, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
Drug Information available for:
Durvalumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: A1
Durvalumab
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Drug: Durvalumab
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 C5D1
Other Name: MEDI4736 |
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Experimental: A2
Durvalumab + danvatirsen
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Drug: Durvalumab
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 C5D1
Other Name: MEDI4736 Drug: Danvatirsen Danvatirsen IV Loading dose C1D1, C1D3, and C1D5 then once a week (q1w) starting at C1D8
Other Name: AZD9150 |
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Experimental: A3
Durvalumab + oleclumab
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Drug: Durvalumab
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 C5D1
Other Name: MEDI4736 Drug: Oleclumab Oleclumab IV Cohort A: Every 2 weeks (q2w) for first 2 cycles, then every 4 weeks (q4w) starting at C3D1 Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at C5D1
Other Name: MEDI9447 |
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Experimental: A4
MEDI5752
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Drug: MEDI5752
MEDI5752 IV Cohort A: Every 3 weeks (q3w) Cohort B: Every 3 weeks (q3w) |
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Experimental: B1
Durvalumab + Investigator's choice of chemotherapy
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Drug: Durvalumab
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 C5D1
Other Name: MEDI4736 Drug: Pemetrexed 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 q3w or 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 Drug: Carboplatin Carboplatin IV Day 1 of each 21-day cycle Drug: Gemcitabine Gemcitabine IV Days 1 and 8 of each 21-day cycle Drug: Cisplatin Cisplatin IV Day 1 of each 21-day cycle Drug: Nab-paclitaxel Nab-paclitaxel IV Days 1, 8, and 15 of each 21-day cycle |
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Experimental: B2
Durvalumab + Investigator's choice of chemotherapy + danvatirsen
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Drug: Durvalumab
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 C5D1
Other Name: MEDI4736 Drug: Danvatirsen Danvatirsen IV Loading dose C1D1, C1D3, and C1D5 then once a week (q1w) starting at C1D8
Other Name: AZD9150 Drug: Pemetrexed 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 q3w or 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 Drug: Carboplatin Carboplatin IV Day 1 of each 21-day cycle Drug: Gemcitabine Gemcitabine IV Days 1 and 8 of each 21-day cycle Drug: Cisplatin Cisplatin IV Day 1 of each 21-day cycle Drug: Nab-paclitaxel Nab-paclitaxel IV Days 1, 8, and 15 of each 21-day cycle |
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Experimental: B3
Durvalumab + investigator's choice of chemotherapy + oleclumab
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Drug: Durvalumab
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 C5D1
Other Name: MEDI4736 Drug: Oleclumab Oleclumab IV Cohort A: Every 2 weeks (q2w) for first 2 cycles, then every 4 weeks (q4w) starting at C3D1 Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at C5D1
Other Name: MEDI9447 Drug: Pemetrexed 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 q3w or 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 Drug: Carboplatin Carboplatin IV Day 1 of each 21-day cycle Drug: Gemcitabine Gemcitabine IV Days 1 and 8 of each 21-day cycle Drug: Cisplatin Cisplatin IV Day 1 of each 21-day cycle Drug: Nab-paclitaxel Nab-paclitaxel IV Days 1, 8, and 15 of each 21-day cycle |
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Experimental: B4
MEDI5752
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Drug: MEDI5752
MEDI5752 IV Cohort A: Every 3 weeks (q3w) Cohort B: Every 3 weeks (q3w) |
Primary Outcome Measures :
- Assessment of AEs by CTCAE v5.0 [ Time Frame: From informed consent until the safety follow-up visit 3 months after the last dose of study drug ]Assessment of safety and tolerability of each treatment arm
Secondary Outcome Measures :
- Objective Response Rate (ORR) [ Time Frame: Approximately 24 months ]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
- Duration of Response (DoR) [ Time Frame: On-study tumor assessments occur every 6-8 weeks until week 48-52, depending on treatment arm and then every 12 weeks thereafter until confirmed radiological progression, death, withdrawal of consent or study completion, up to approximately 24 months ]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
- Progression Free Survival (PFS) [ Time Frame: Tumor assessments occur every 6-8 weeks until week 48-52 based on treatment arm & then every 12 weeks until progression, death, withdrawal or study completion up to 24 months. Further PFS data will be collected until 6 months post-last patient dosed ]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)
- Overall Survival (OS) [ Time Frame: Approximately 42 months. Additional OS data will be collected until approximately 6 months post-last patient dosed ]OS: Time from date of treatment assignment until the date of death by any cause
- Blood concentration of durvalumab and novel oncology therapies [ Time Frame: From Cycle 1 Day 1 until Cycle 7 Day 1 (each cycle is 28 days) and every 12 weeks thereafter until 3 months following treatment discontinuation ]Drug concentration of durvalumab and novel oncology therapies
- Frequency of anti-drug antibodies (ADAs) for durvalumab and applicable novel oncology therapies [ Time Frame: From Cycle 1 Day 1 until Cycle 7 Day 1 (each cycle is 28 days) and every 12 weeks thereafter until 6 months following treatment discontinuation ]Investigation of the immunogenicity of durvalumab and each applicable novel oncology therapy in all applicable treatment arms
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| Ages Eligible for Study: | 18 Years to 130 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation
- No prior chemotherapy or any other systemic therapy for metastatic NSCLC
- Prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for advanced disease are eligible, if progression has occurred >12 months from end of last therapy
- Known tumor PD-L1 status
- WHO/ECOG status at 0 or 1 at enrollment
- Life expectancy of at least 12 weeks
- Troponin I or T ≤ ULN (per institutional guidelines)
Exclusion Criteria:
- Active or prior documented autoimmune or inflammatory disorders
- History of active primary immunodeficiency
- Any prior chemotherapy or any other systemic therapy for metastatic NSCLC
- Untreated CNS metastases
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819465
Contacts
| Contact: AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com | |
| Contact: AstraZeneca Cancer Study Locator Service | 1-877-400-4656 | AstraZeneca@emergingmed.com |
Locations
Show 50 study locations
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Sandip Patel, MD | UCSD Morres Cancer Center |
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT03819465 |
| Other Study ID Numbers: |
D933IC00001 2018-001748-74 ( EudraCT Number ) |
| First Posted: | January 28, 2019 Key Record Dates |
| Last Update Posted: | February 26, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | 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. |
| Access Criteria: | 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. |
| URL: | https://astrazenecagroup-dt.pharmacm.com/DT/Home |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by AstraZeneca:
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First-Line Stage IV Metastatic Non-Small Cell Lung Cancer Stage IV Metastatic Non-Small Cell Lung Cancer Metastatic Non-Small Cell Lung Cancer Non-Small Cell Lung Cancer |
Non-Small Cell Lung Non-Small Cell NSCLC Non-Small Cell Lung Carcinoma |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Gemcitabine Paclitaxel Cisplatin Carboplatin Pemetrexed |
Durvalumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |