Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

March 8, 2019

Primary Completion Date

January 13, 2021

Study Completion Date

January 13, 2021

Conditions
ResectableEarly-stageNSCLC
Interventions
DRUG

Durvalumab

Durvalumab 1500 mg IV will be administered Q4W (on Week 1 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.

COMBINATION_PRODUCT

Oleclumab

Oleclumab 3000 mg IV will be administered Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.

COMBINATION_PRODUCT

Monalizumab

Monalizumab 750 mg IV will be administered Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.

COMBINATION_PRODUCT

Danvatirsen

Danvatirsen 200 mg IV will be administered on Days 1, 3, and 5 of Week 0 (7-day danvatirsen lead-in period) and later every week (on Week 1 Day 1, Week 2 Day 1, Week 3 Day 1, and Week 4 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.

Trial Locations (18)

8091

Research Site, Zurich

10016

Research Site, New York

10043

Research Site, Orbassano

13009

Research Site, Marseille

14263

Research Site, Buffalo

15001

Research Site, A Coruña

21231

Research Site, Baltimore

22031

Research Site, Fairfax

31059

Research Site, Toulouse

33901

Research Site, Fort Myers

34748

Research Site, Leesburg

37203

Research Site, Nashville

37404

Research Site, Chattanooga

77030

Research Site, Houston

92093

Research Site, La Jolla

H4A 3J1

Research Site, Montreal

4200-072

Research Site, Porto

08916

Research Site, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MedImmune LLC

INDUSTRY

NCT03794544 - Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer | Biotech Hunter | Biotech Hunter