NCT03819465

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

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)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Metastatic Non-Small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
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
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
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
DRUG	MEDI5752	MEDI5752 IV Every 3 weeks (q3w)
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
DRUG	AZD2936	AZD2936 IV

Timeline

• Start date: 2018-12-27
• Primary completion: 2023-05-23
• Completion: 2026-03-26
• First posted: 2019-01-28
• Last updated: 2026-02-11

Locations

41 sites across 9 countries: United States, Austria, Belgium, Poland, Russia, South Korea, Spain, Taiwan, Thailand

Regulatory

• FDA-regulated drug study