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

NCT03819465

Active Not RecruitingPhase 1

Sponsor: AstraZeneca

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

Interventions: Durvalumab, Danvatirsen, Oleclumab, MEDI5752, Pemetrexed

Countries: United States, Austria, Belgium, Poland, Russia, South Korea, Spain, Taiwan

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)

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (41)
  • Iowa City, Iowa, United States
  • Pittsburgh, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Salzburg, Austria
  • Vienna, Austria
  • Edegem, Belgium
  • Bialystok, Poland
  • Bydgoszcz, Poland
  • Gdansk, Poland
  • Grudziądz, Poland
  • Lodz, Poland
  • Olsztyn, Poland
  • Tomaszów Mazowiecki, Poland
  • Warsaw, Poland
  • Wroclaw, Poland
  • Krasnoyarsk, Russia
  • Moscow, Russia
  • Saint Petersburg, Russia
  • Saint Petersburg, Russia
  • Cheongju-si, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Barcelona, Spain
  • Barcelona, Spain
  • Madrid, Spain
  • Madrid, Spain
  • Seville, Spain
  • Kaohsiung City, Taiwan
  • + 11 more on CT.gov