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

NCT03819465 · tracked via the Priya Life Science Belgium tracker

Sponsor

AstraZeneca

Phase

Phase 1

Started

2018-12-27

Last updated

2026-05-12

Condition(s) studied

Metastatic Non-Small Cell Lung Cancer (NSCLC)

Investigational drug(s) / intervention(s)

Durvalumab →Danvatirsen →Oleclumab →MEDI5752 →Pemetrexed →Carboplatin →Gemcitabine →Cisplatin →Nab-paclitaxel →AZD2936 →

Durvalumab: 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

Danvatirsen: 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

Oleclumab: 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

MEDI5752: MEDI5752 IV Every 3 weeks (q3w)

Pemetrexed: 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

Carboplatin: Carboplatin IV Day 1 of each 21-day cycle

Gemcitabine: Gemcitabine IV Days 1 and 8 of each 21-day cycle

Cisplatin: Cisplatin IV Day 1 of each 21-day cycle

Nab-paclitaxel: Nab-paclitaxel IV Days 1, 8, and 15 of each 21-day cycle

AZD2936: AZD2936 IV

Study 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)

Eligibility

Sex

ALL

Min age

18 Years

Max age

130 Years

Healthy volunteers

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

Primary outcome measure(s)

Assessment of AEs by CTCAE v5.0 — 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

Trial sites (41)

Facility	City	Region
Research Site	Iowa City	Iowa
Research Site	Pittsburgh	Pennsylvania
Research Site	Nashville	Tennessee
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
Research Site	Barcelona	Spain
Research Site	Madrid	Spain
Research Site	Madrid	Spain
Research Site	Seville	Spain
Research Site	Kaohsiung City	Taiwan
Research Site	Taichung	Taiwan
Research Site	Taichung	Taiwan
Research Site	Tainan	Taiwan
Research Site	Taipei	Taiwan
Research Site	Taipei	Taiwan
Research Site	Taipei	Taiwan
Research Site	Taoyuan	Taiwan
Research Site	Bangkok	Thailand
Research Site	Bangkok	Thailand
Research Site	Chiang Mai	Thailand

+ 1 more sites — see the full list on the official registry below.

On this site

📄 Imfinzi (durvalumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03819465 on ClinicalTrials.gov ↗ ← All trials in Belgium