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

Running, not enrolling · Phase 1

Conditions studied: Metastatic Non-Small Cell Lung Cancer (NSCLC)

In brief

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)

Key facts

Study ID

NCT03819465

Run by

AstraZeneca

People needed

175

Starts

2018-12-27

Expected to finish

2026-07-01

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Research Site — Iowa City, Iowa, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Salzburg, Austria
• Research Site — Vienna, Austria
• Research Site — Edegem, Belgium
• Research Site — Bialystok, Poland
• Research Site — Bydgoszcz, Poland
• Research Site — Gdansk, Poland
• Research Site — Grudziądz, Poland
• Research Site — Lodz, Poland
• Research Site — Olsztyn, Poland
• Research Site — Tomaszów Mazowiecki, Poland
• Research Site — Warsaw, Poland
• Research Site — Wroclaw, Poland
• Research Site — Krasnoyarsk, Russia
• Research Site — Moscow, Russia
• Research Site — Saint Petersburg, Russia
• Research Site — Saint Petersburg, Russia
• Research Site — Cheongju-si, South Korea
• Research Site — Seoul, South Korea
• Research Site — Seoul, South Korea
• Research Site — Seoul, South Korea
• Research Site — Seoul, South Korea
• Research Site — Barcelona, Spain

Full record on ClinicalTrials.gov

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