Metastatic Non-Small Cell Lung Cancer (NSCLC)Phase 1MAGELLANNCT03819465
A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC
A Phase 1 study testing Durvalumab, Danvatirsen and Oleclumab in people with Metastatic Non-Small Cell Lung Cancer (NSCLC), run by AstraZeneca at 41 sites in 9 countries.
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) Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Metastatic Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- Durvalumab, Danvatirsen and Oleclumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 41 sitesin 9 countries
- Study dates
- 27 Dec 2018to 1 Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
41 sites in 9 countries.
41 sites in 9 countries
Poland9 sites
Research Site
Bialystok, 15-027
Research Site
Bydgoszcz, 85-796
Research Site
Gdansk, 80-214
Research Site
Grudziądz, 86-300
Research Site
Lodz, 90-302
Research Site
Olsztyn, 10-357
Research Site
Tomaszów Mazowiecki, 97-200
Research Site
Warsaw, 02-781
Research Site
Wroclaw, 53-413
Taiwan8 sites
Research Site
Kaohsiung City, 807
Research Site
Taichung, 402
Research Site
Taichung, 40705
Research Site
Tainan, 70403
Research Site
Taipei, 10002
Research Site
Taipei, 112
Research Site
Taipei, 235
Research Site
Taoyuan, 333
South Korea5 sites
Research Site
Cheongju-si, 28644
Research Site
Seoul, 03722
Research Site
Seoul, 05505
Research Site
Seoul, 06351
Research Site
Seoul, 110-744
Spain5 sites
Research Site
Barcelona, 08025
Research Site
Barcelona, 8003
Research Site
Madrid, 28034
Research Site
Madrid, 28041
Research Site
Seville, 41013
Russia4 sites
Research Site
Krasnoyarsk, 660133
Research Site
Moscow, 115478
Research Site
Saint Petersburg, 191014
Research Site
Saint Petersburg, 197758
Thailand4 sites
Research Site
Bangkok, 10330
Research Site
Bangkok, 10700
Research Site
Chiang Mai, 50200
Research Site
Hat Yai, 90110
United States3 sites
Research Site
Iowa City, Iowa, 52242
Research Site
Nashville, Tennessee, 37203
Research Site
Pittsburgh, Pennsylvania, 15212
About this study
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)
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)
Read the 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).
- Being tested
- Durvalumab, Danvatirsen, Oleclumab, MEDI5752, Pemetrexed
- 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
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called MEDI4736
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
DanvatirsenDrug
Also called AZD9150
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
OleclumabDrug
Also called MEDI9447
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
MEDI5752Drug
MEDI5752 IV Every 3 weeks (q3w)
PemetrexedDrug
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
CarboplatinDrug
Carboplatin IV Day 1 of each 21-day cycle
GemcitabineDrug
Gemcitabine IV Days 1 and 8 of each 21-day cycle
CisplatinDrug
Cisplatin IV Day 1 of each 21-day cycle
Nab-paclitaxelDrug
Nab-paclitaxel IV Days 1, 8, and 15 of each 21-day cycle
AZD2936Drug
AZD2936 IV
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Durvalumab Receives: Drug: Durvalumab |
| A2 | Experimental | Durvalumab + danvatirsen Receives: Drug: Durvalumab; Drug: Danvatirsen |
| A3 | Experimental | Durvalumab + oleclumab Receives: Drug: Durvalumab; Drug: Oleclumab |
| A4 | Experimental | MEDI5752 Receives: Drug: MEDI5752 |
| B1 | Experimental | Durvalumab + Investigator's choice of chemotherapy Receives: Drug: Durvalumab; Drug: Pemetrexed; Drug: Carboplatin; Drug: Gemcitabine; Drug: Cisplatin; Drug: Nab-paclitaxel |
| B2 | Experimental | Durvalumab + Investigator's choice of chemotherapy + danvatirsen Receives: Drug: Durvalumab; Drug: Danvatirsen; Drug: Pemetrexed; Drug: Carboplatin; Drug: Gemcitabine; Drug: Cisplatin; Drug: Nab-paclitaxel |
| B3 | Experimental | Durvalumab + investigator's choice of chemotherapy + oleclumab Receives: Drug: Durvalumab; Drug: Oleclumab; Drug: Pemetrexed; Drug: Carboplatin; Drug: Gemcitabine; Drug: Cisplatin; Drug: Nab-paclitaxel |
| B4 | Experimental | MEDI5752 Receives: Drug: MEDI5752 |
| A5 | Experimental | AZD2936 Receives: Drug: AZD2936 |
| B5 | Experimental | AZD2936 + chemotherapy Receives: Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin; Drug: AZD2936 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of AEs by CTCAE v5.0
Assessment of safety and tolerability of each treatment arm
Measured: 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 outcomes (6)
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
Measured: 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).
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
Measured: 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).
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)
Measured: 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
Overall Survival (OS)
OS: Time from date of treatment assignment until the date of death by any cause
Measured: OS data will be collected until death, 6 months after last patient dosed, or the final DCO date, whichever is earlier.
Blood concentration of durvalumab and novel oncology therapies
Drug concentration of durvalumab and novel oncology therapies
Measured: 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.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start27 Dec 2018
- Primary completion23 May 2023
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandip Patel, MD, Principal investigator, UCSD Morres Cancer CenterChih-Hsin Yang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819465
- Sponsor's protocol ID
- D933IC00001
- Other IDs
- 2018-001748-74, 2018
- Acronym
- MAGELLAN
- Status last verified
- May 2026
- First submitted
- 13 Dec 2018
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Cho BC, Charoentum C, Kim DW, Yang CT, Dziadziuszko R, Geater SL, Mann H, Afshar-Imani B, Lyfar P, Yang JC, Patel SP. MAGELLAN arms B1 and B3: Durvalumab plus chemotherapy with and without oleclumab in treatment-naive metastatic non-small-cell lung cancer. Lung Cancer. 2026 Jan;211:108834. doi: 10.1016/j.lungcan.2025.108834. Epub 2025 Nov 7.
PubMed 41380462
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03819465
- Acronym / sponsor ID
- MAGELLAN / D933IC00001
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 175 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2018 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
- 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).
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: DurvalumabDurvalumab |
| A2 | Experimental | Drug: Durvalumab, Drug: DanvatirsenDurvalumab + danvatirsen |
| A3 | Experimental | Drug: Durvalumab, Drug: OleclumabDurvalumab + oleclumab |
| A4 | Experimental | Drug: MEDI5752MEDI5752 |
| B1 | Experimental | Drug: Durvalumab, Drug: Pemetrexed, Drug: Carboplatin, Drug: Gemcitabine, Drug: Cisplatin, Drug: Nab-paclitaxelDurvalumab + Investigator's choice of chemotherapy |
| B2 | Experimental | Drug: Durvalumab, Drug: Danvatirsen, Drug: Pemetrexed, Drug: Carboplatin, Drug: Gemcitabine, Drug: Cisplatin, Drug: Nab-paclitaxelDurvalumab + Investigator's choice of chemotherapy + danvatirsen |
| B3 | Experimental | Drug: Durvalumab, Drug: Oleclumab, Drug: Pemetrexed, Drug: Carboplatin, Drug: Gemcitabine, Drug: Cisplatin, Drug: Nab-paclitaxelDurvalumab + investigator's choice of chemotherapy + oleclumab |
| B4 | Experimental | Drug: MEDI5752MEDI5752 |
| A5 | Experimental | Drug: AZD2936AZD2936 |
| B5 | Experimental | Drug: Pemetrexed, Drug: Carboplatin, Drug: Cisplatin, Drug: AZD2936AZD2936 + chemotherapy |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: MEDI4736Durvalumab 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 | A1, A2, A3, B1, B2, B3 |
| DanvatirsenAlso: AZD9150Danvatirsen 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 | A2, B2 |
| OleclumabAlso: MEDI9447Oleclumab 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 | A3, B3 |
| MEDI5752MEDI5752 IV Every 3 weeks (q3w) | Drug | A4, B4 |
| PemetrexedPemetrexed 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 | B1, B2, B3, B5 |
| CarboplatinCarboplatin IV Day 1 of each 21-day cycle | Drug | B1, B2, B3, B5 |
| GemcitabineGemcitabine IV Days 1 and 8 of each 21-day cycle | Drug | B1, B2, B3 |
| CisplatinCisplatin IV Day 1 of each 21-day cycle | Drug | B1, B2, B3, B5 |
| Nab-paclitaxelNab-paclitaxel IV Days 1, 8, and 15 of each 21-day cycle | Drug | B1, B2, B3 |
| AZD2936AZD2936 IV | Drug | A5, B5 |
Primary outcome
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
6 secondary outcomes
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).
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).
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
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 41380462Cho BC, Charoentum C, Kim DW, Yang CT, Dziadziuszko R, Geater SL, Mann H, Afshar-Imani B, Lyfar P, Yang JC, Patel SP. MAGELLAN arms B1 and B3: Durvalumab plus chemotherapy with and without oleclumab in treatment-naive metastatic non-small-cell lung cancer. Lung Cancer. 2026 Jan;211:108834. doi: 10.1016/j.lungcan.2025.108834. Epub 2025 Nov 7.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandip Patel, MD principal investigator
UCSD Morres Cancer Center
Chih-Hsin Yang, MD principal investigator
National Taiwan University Hospital
41 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Durvalumab, Danvatirsen and Oleclumab in people with Metastatic Non-Small Cell Lung Cancer (NSCLC), run by AstraZeneca at 41 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Poland, Taiwan, South Korea, Spain, Russia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03819465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.