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A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC (MAGELLAN)

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ClinicalTrials.gov Identifier: NCT03819465
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Detailed Description:
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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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

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 C5D1
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 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

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 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

Experimental: A4
MEDI5752
Drug: MEDI5752
MEDI5752 IV Cohort A: Every 3 weeks (q3w) Cohort B: 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 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

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 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

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 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

Experimental: B4
MEDI5752
Drug: MEDI5752
MEDI5752 IV Cohort A: Every 3 weeks (q3w) Cohort B: Every 3 weeks (q3w)




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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)

  4. 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

  5. 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

  6. 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



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.


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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
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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
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Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Sandip Patel, MD UCSD Morres Cancer Center
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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

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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:
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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