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Anti-Cancer Agents for Non-Small Cell Lung Cancer (MAGELLAN Trial)
Phase 1
Waitlist Available
Led By Sandip Patel, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No prior chemotherapy or any other systemic therapy for metastatic NSCLC
Known tumor PD-L1 status
Must not have
Active or prior documented autoimmune or inflammatory disorders
Untreated CNS metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
No Placebo-Only Group
Summary
This trial will study if durvalumab, with or without other cancer treatments, can help treat patients with first-line stage IV NSCLC.
Who is the study for?
This trial is for adults with Stage IV Non-Small Cell Lung Cancer (NSCLC) who haven't had systemic therapy for metastatic NSCLC. They should not have certain gene mutations treatable by approved drugs, must be in good physical condition (WHO/ECOG 0 or 1), and expected to live at least 12 weeks. People with autoimmune diseases, immunodeficiency, or untreated brain metastases can't join.
What is being tested?
The study tests the effectiveness and safety of durvalumab alone or combined with other new cancer treatments and chemotherapy options like Gemcitabine, Carboplatin, Nab-paclitaxel, Pemetrexed, Cisplatin for first-line treatment of advanced lung cancer.
What are the potential side effects?
Possible side effects include immune-related reactions affecting different organs, infusion-related symptoms such as fever or chills, fatigue from treatment burden on the body's energy resources; digestive issues like nausea; blood disorders that affect cell counts; increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had chemotherapy or any treatment for my advanced lung cancer.
Select...
I know my tumor's PD-L1 status.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My tumor does not have EGFR mutations or ALK fusions.
Select...
My lung cancer is at stage IV and cannot be cured with surgery or radiation.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have or had an autoimmune or inflammatory disorder.
Select...
I have brain metastases that have not been treated.
Select...
I have not had chemotherapy or systemic therapy for advanced lung cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assessment of AEs by CTCAE v5.0
Secondary study objectives
Blood concentration of durvalumab and novel oncology therapies
Duration of Response (DoR)
Frequency of anti-drug antibodies (ADAs) for durvalumab and applicable novel oncology therapies
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
10Treatment groups
Experimental Treatment
Group I: B5Experimental Treatment4 Interventions
AZD2936 + chemotherapy
Group II: B4Experimental Treatment1 Intervention
MEDI5752
Group III: B3Experimental Treatment7 Interventions
Durvalumab + investigator's choice of chemotherapy + oleclumab
Group IV: B2Experimental Treatment7 Interventions
Durvalumab + Investigator's choice of chemotherapy + danvatirsen
Group V: B1Experimental Treatment6 Interventions
Durvalumab + Investigator's choice of chemotherapy
Group VI: A5Experimental Treatment1 Intervention
AZD2936
Group VII: A4Experimental Treatment1 Intervention
MEDI5752
Group VIII: A3Experimental Treatment2 Interventions
Durvalumab + oleclumab
Group IX: A2Experimental Treatment2 Interventions
Durvalumab + danvatirsen
Group X: A1Experimental Treatment1 Intervention
Durvalumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 4
~3880
Oleclumab
2015
Completed Phase 2
~880
Gemcitabine
2017
Completed Phase 3
~1920
Carboplatin
2014
Completed Phase 3
~6120
Nab-paclitaxel
2014
Completed Phase 3
~1950
Pemetrexed
2014
Completed Phase 3
~5550
Cisplatin
2013
Completed Phase 3
~3120
Danvatirsen
2019
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,277 Total Patients Enrolled
Sandip Patel, MDPrincipal InvestigatorUCSD Morres Cancer Center
Chih-Hsin Yang, MDPrincipal InvestigatorNational Taiwan University Hospital