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

Metastatic Non-Small Cell Lung Cancer (NSCLC) Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03819465
• Other study ID #: D933IC00001
• Secondary ID: 2018-001748-74
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 27, 2018
• Est. completion date: March 26, 2026

Study information

• Verified date: February 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 175
• Est. completion date: March 26, 2026
• Est. primary completion date: May 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Non-Small Cell Lung Cancer (NSCLC)

Intervention

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
• 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
• 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
• MEDI5752
MEDI5752 IV Every 3 weeks (q3w)
• 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
• Carboplatin
Carboplatin IV Day 1 of each 21-day cycle
• Gemcitabine
Gemcitabine IV Days 1 and 8 of each 21-day cycle
• Cisplatin
Cisplatin IV Day 1 of each 21-day cycle
• Nab-paclitaxel
Nab-paclitaxel IV Days 1, 8, and 15 of each 21-day cycle
• AZD2936
AZD2936 IV

Locations

Country	Name	City	State
Austria	Research Site	Salzburg
Austria	Research Site	Wien
Belgium	Research Site	Edegem
Korea, Republic of	Research Site	Cheongju-si
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Gdansk
Poland	Research Site	Grudziadz
Poland	Research Site	Lódz
Poland	Research Site	Olsztyn
Poland	Research Site	Tomaszów Mazowiecki
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Russian Federation	Research Site	Krasnoyarsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Sankt-Peterburg
Russian Federation	Research Site	St.Petersburg
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Sevilla
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taichung City
Taiwan	Research Site	Tainan City
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taoyuan
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Chiang Mai
Thailand	Research Site	Hat Yai
United States	Research Site	Iowa City	Iowa
United States	Research Site	Nashville	Tennessee
United States	Research Site	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Korea, Republic of,  Poland,  Russian Federation,  Spain,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of AEs by CTCAE v5.0	Assessment of safety and tolerability of each treatment arm	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	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	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).
Secondary	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	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).
Secondary	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)	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
Secondary	Overall Survival (OS)	OS: Time from date of treatment assignment until the date of death by any cause	OS data will be collected until death, 6 months after last patient dosed, or the final DCO date, whichever is earlier.
Secondary	Blood concentration of durvalumab and novel oncology therapies	Drug concentration of durvalumab and novel oncology therapies	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.
Secondary	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	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.