Lung Cancer Clinical Trial

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

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)

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Full 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).

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

258

Study ID:

NCT03819465

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

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There are 45 Locations for this study

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Research Site
Iowa City Iowa, 52242, United States
Research Site
Pittsburgh Pennsylvania, 15212, United States
Research Site
Nashville Tennessee, 37203, United States
Research Site
Salzburg , 5020, Austria
Research Site
Wien , 1140, Austria
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Edegem , 2650, Belgium
Research Site
Edmonton Alberta, T6G 1, Canada
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Toronto , M5G 2, Canada
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Cheongju-si , 28644, Korea, Republic of
Research Site
Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Bialystok , 15-02, Poland
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Bydgoszcz , 85-79, Poland
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Gdańsk , 80-21, Poland
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GrudziÄ…dz , 86-30, Poland
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Olsztyn , 10-35, Poland
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Poznan , 60-69, Poland
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Tomaszów Mazowiecki , 97-20, Poland
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Warszawa , 02-78, Poland
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Wroclaw , 53-41, Poland
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Łódź , 90-30, Poland
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Krasnoyarsk , 66013, Russian Federation
Research Site
Moscow , 11547, Russian Federation
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Saint Petersburg , 19775, Russian Federation
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Sankt-Peterburg , 19775, Russian Federation
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St.Petersburg , 19101, Russian Federation
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Barcelona , 08025, Spain
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Barcelona , 08035, Spain
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Barcelona , 8003, Spain
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Madrid , 28034, Spain
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Madrid , 28041, Spain
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Sevilla , 41013, Spain
Research Site
Kaohsiung , 807, Taiwan
Research Site
Taichung City , 402, Taiwan
Research Site
Taichung , 40705, Taiwan
Research Site
Tainan City , 70403, Taiwan
Research Site
Taipei , 10002, Taiwan
Research Site
Taipei , 112, Taiwan
Research Site
Taipei , 235, Taiwan
Research Site
Taoyuan , 333, Taiwan
Research Site
Bangkok , 10330, Thailand
Research Site
Bangkok , 10700, Thailand
Research Site
Chiang Mai , 50200, Thailand
Research Site
Hat Yai , 90110, Thailand

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

258

Study ID:

NCT03819465

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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