A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC (MAGELLAN)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03819465 |
|
Recruitment Status :
Active, not recruiting
First Posted : January 28, 2019
Last Update Posted : February 28, 2024
|
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 Drug: AZD2936 | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 175 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. 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). |
| 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 |
| Actual Primary Completion Date : | May 23, 2023 |
| Estimated Study Completion Date : | March 26, 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
Drug Information
available for:
Durvalumab
| Arm | Intervention/treatment |
|---|---|
|
Experimental: A1
Durvalumab
|
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 Cycle 5 Day 1
Other Name: MEDI4736 |
|
Experimental: A2
Durvalumab + danvatirsen
|
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 Cycle 5 Day 1
Other Name: MEDI4736 Drug: Danvatirsen 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
Other Name: AZD9150 |
|
Experimental: A3
Durvalumab + oleclumab
|
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 Cycle 5 Day 1
Other Name: MEDI4736 Drug: Oleclumab 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
Other Name: MEDI9447 |
|
Experimental: A4
MEDI5752
|
Drug: MEDI5752
MEDI5752 IV Every 3 weeks (q3w) |
|
Experimental: B1
Durvalumab + Investigator's choice of chemotherapy
|
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 Cycle 5 Day 1
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 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 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 |
|
Experimental: B2
Durvalumab + Investigator's choice of chemotherapy + danvatirsen
|
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 Cycle 5 Day 1
Other Name: MEDI4736 Drug: Danvatirsen 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
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 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 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 |
|
Experimental: B3
Durvalumab + investigator's choice of chemotherapy + oleclumab
|
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 Cycle 5 Day 1
Other Name: MEDI4736 Drug: Oleclumab 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
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 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 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 |
|
Experimental: B4
MEDI5752
|
Drug: MEDI5752
MEDI5752 IV Every 3 weeks (q3w) |
|
Experimental: A5
AZD2936
|
Drug: AZD2936
AZD2936 IV |
|
Experimental: B5
AZD2936 + chemotherapy
|
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 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 Drug: Carboplatin Carboplatin IV Day 1 of each 21-day cycle Drug: Cisplatin Cisplatin IV Day 1 of each 21-day cycle Drug: AZD2936 AZD2936 IV |
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, or until the final data cut-off (DCO) date, whichever is earlier. ]Assessment of safety and tolerability of each treatment arm
Secondary Outcome Measures :
- Objective Response Rate (ORR) [ Time Frame: 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). ]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: 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). ]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 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 ]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: OS data will be collected until death, 6 months after last patient dosed, or the final DCO date, whichever is earlier. ]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 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. ]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 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. ]Investigation of the immunogenicity of durvalumab and each applicable novel oncology therapy in all applicable treatment arms
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
- Tumors that lack activating EGFR mutations and ALK fusions or documented local test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care
- 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
Locations
| United States, Iowa | |
| Research Site | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Pennsylvania | |
| Research Site | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| United States, Tennessee | |
| Research Site | |
| Nashville, Tennessee, United States, 37203 | |
| Austria | |
| Research Site | |
| Salzburg, Austria, 5020 | |
| Research Site | |
| Wien, Austria, 1140 | |
| Belgium | |
| Research Site | |
| Edegem, Belgium, 2650 | |
| Korea, Republic of | |
| Research Site | |
| Cheongju-si, Korea, Republic of, 28644 | |
| Research Site | |
| Seoul, Korea, Republic of, 03722 | |
| Research Site | |
| Seoul, Korea, Republic of, 05505 | |
| Research Site | |
| Seoul, Korea, Republic of, 06351 | |
| Research Site | |
| Seoul, Korea, Republic of, 110-744 | |
| Poland | |
| Research Site | |
| Bialystok, Poland, 15-027 | |
| Research Site | |
| Bydgoszcz, Poland, 85-796 | |
| Research Site | |
| Gdańsk, Poland, 80-214 | |
| Research Site | |
| Grudziądz, Poland, 86-300 | |
| Research Site | |
| Olsztyn, Poland, 10-357 | |
| Research Site | |
| Tomaszów Mazowiecki, Poland, 97-200 | |
| Research Site | |
| Warszawa, Poland, 02-781 | |
| Research Site | |
| Wroclaw, Poland, 53-413 | |
| Research Site | |
| Łódź, Poland, 90-302 | |
| Russian Federation | |
| Research Site | |
| Krasnoyarsk, Russian Federation, 660133 | |
| Research Site | |
| Moscow, Russian Federation, 115478 | |
| Research Site | |
| Saint Petersburg, Russian Federation, 197758 | |
| Research Site | |
| Sankt-Peterburg, Russian Federation, 197758 | |
| Research Site | |
| St.Petersburg, Russian Federation, 191014 | |
| Spain | |
| Research Site | |
| Barcelona, Spain, 08025 | |
| Research Site | |
| Barcelona, Spain, 8003 | |
| Research Site | |
| Madrid, Spain, 28034 | |
| Research Site | |
| Madrid, Spain, 28041 | |
| Research Site | |
| Sevilla, Spain, 41013 | |
| Taiwan | |
| Research Site | |
| Kaohsiung, Taiwan, 807 | |
| Research Site | |
| Taichung City, Taiwan, 402 | |
| Research Site | |
| Taichung, Taiwan, 40705 | |
| Research Site | |
| Tainan City, Taiwan, 70403 | |
| Research Site | |
| Taipei, Taiwan, 10002 | |
| Research Site | |
| Taipei, Taiwan, 112 | |
| Research Site | |
| Taipei, Taiwan, 235 | |
| Research Site | |
| Taoyuan, Taiwan, 333 | |
| Thailand | |
| Research Site | |
| Bangkok, Thailand, 10330 | |
| Research Site | |
| Bangkok, Thailand, 10700 | |
| Research Site | |
| Chiang Mai, Thailand, 50200 | |
| Research Site | |
| Hat Yai, Thailand, 90110 | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Sandip Patel, MD | UCSD Morres Cancer Center | |
| Principal Investigator: | Chih-Hsin Yang, MD | National Taiwan University Hospital |
| 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 28, 2024 |
| Last Verified: | February 2024 |
| 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 requests 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:
|
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:
|
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 Paclitaxel Carboplatin Gemcitabine Pemetrexed |
Durvalumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Antineoplastic Agents, Immunological |