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Active, Not Recruiting

NCT Number: NCT03819465

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

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Metastatic Non-Small Cell Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Salzburg, Austria

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: MEDI4736

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

Other names: AZD9150

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

Other names: MEDI9447

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

Primary outcomes

  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, or until the final data cut-off (DCO) date, whichever is earlier.

    Assessment of safety and tolerability of each treatment arm

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Acronym: MAGELLAN

Important dates

Study start
2018
Primary completion
2023
Study completion
2026
First posted
Jan 28, 2019
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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