search
Back to results

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

Primary Purpose

Metastatic Non-Small Cell Lung Cancer (NSCLC)

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Durvalumab
Danvatirsen
Oleclumab
MEDI5752
Pemetrexed
Carboplatin
Gemcitabine
Cisplatin
Nab-paclitaxel
AZD2936
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Non-Small Cell Lung Cancer (NSCLC) focused on measuring 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

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

A1

A2

A3

A4

B1

B2

B3

B4

A5

B5

Arm Description

Durvalumab

Durvalumab + danvatirsen

Durvalumab + oleclumab

MEDI5752

Durvalumab + Investigator's choice of chemotherapy

Durvalumab + Investigator's choice of chemotherapy + danvatirsen

Durvalumab + investigator's choice of chemotherapy + oleclumab

MEDI5752

AZD2936

AZD2936 + chemotherapy

Outcomes

Primary Outcome Measures

Assessment of AEs by CTCAE v5.0
Assessment of safety and tolerability of each treatment arm

Secondary Outcome Measures

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
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
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)
Overall Survival (OS)
OS: Time from date of treatment assignment until the date of death by any cause
Blood concentration of durvalumab and novel oncology therapies
Drug concentration of durvalumab and novel oncology therapies
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

Full Information

First Posted
December 13, 2018
Last Updated
May 29, 2023
Sponsor
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT03819465
Brief Title
A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC
Acronym
MAGELLAN
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 27, 2018 (Actual)
Primary Completion Date
May 23, 2023 (Anticipated)
Study Completion Date
May 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Non-Small Cell Lung Cancer (NSCLC)
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Experimental
Arm Description
Durvalumab
Arm Title
A2
Arm Type
Experimental
Arm Description
Durvalumab + danvatirsen
Arm Title
A3
Arm Type
Experimental
Arm Description
Durvalumab + oleclumab
Arm Title
A4
Arm Type
Experimental
Arm Description
MEDI5752
Arm Title
B1
Arm Type
Experimental
Arm Description
Durvalumab + Investigator's choice of chemotherapy
Arm Title
B2
Arm Type
Experimental
Arm Description
Durvalumab + Investigator's choice of chemotherapy + danvatirsen
Arm Title
B3
Arm Type
Experimental
Arm Description
Durvalumab + investigator's choice of chemotherapy + oleclumab
Arm Title
B4
Arm Type
Experimental
Arm Description
MEDI5752
Arm Title
A5
Arm Type
Experimental
Arm Description
AZD2936
Arm Title
B5
Arm Type
Experimental
Arm Description
AZD2936 + chemotherapy
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
MEDI4736
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Danvatirsen
Other Intervention Name(s)
AZD9150
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Oleclumab
Other Intervention Name(s)
MEDI9447
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
MEDI5752
Intervention Description
MEDI5752 IV Every 3 weeks (q3w)
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin IV Day 1 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine IV Days 1 and 8 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin IV Day 1 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Intervention Description
Nab-paclitaxel IV Days 1, 8, and 15 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
AZD2936
Intervention Description
AZD2936 IV
Primary Outcome Measure Information:
Title
Assessment of AEs by CTCAE v5.0
Description
Assessment of safety and tolerability of each treatment arm
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.
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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
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).
Title
Duration of Response (DoR)
Description
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
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).
Title
Progression Free Survival (PFS)
Description
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)
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
Title
Overall Survival (OS)
Description
OS: Time from date of treatment assignment until the date of death by any cause
Time Frame
OS data will be collected until death, 6 months after last patient dosed, or the final DCO date, whichever is earlier.
Title
Blood concentration of durvalumab and novel oncology therapies
Description
Drug 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.
Title
Frequency of anti-drug antibodies (ADAs) for durvalumab and applicable novel oncology therapies
Description
Investigation of the immunogenicity of durvalumab and each applicable novel oncology therapy in all applicable treatment arms
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandip Patel, MD
Organizational Affiliation
UCSD Morres Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chih-Hsin Yang, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Research Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Research Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Research Site
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Research Site
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Research Site
City
Grudziądz
ZIP/Postal Code
86-300
Country
Poland
Facility Name
Research Site
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Research Site
City
Tomaszów Mazowiecki
ZIP/Postal Code
97-200
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
53-413
Country
Poland
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Research Site
City
Krasnoyarsk
ZIP/Postal Code
660133
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Research Site
City
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Research Site
City
St.Petersburg
ZIP/Postal Code
191014
Country
Russian Federation
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Research Site
City
Taichung City
ZIP/Postal Code
402
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Research Site
City
Tainan City
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
235
Country
Taiwan
Facility Name
Research Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Research Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Research Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home

Learn more about this trial

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

We'll reach out to this number within 24 hrs