Phase II Umbrella Study of Novel Anti-cancer Agents in Participants With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy
Condition(s) studied
Investigational drug(s) / intervention(s)
Durvalumab: Participants will receive IV infusion of durvalumab as stated in arm description.
Danvatirsen: Participants will receive IV infusion of danvatirsen as stated in arm description.
Ceralasertib: Participants will receive oral tablet of ceralasertib as stated in arm description.
Vistusertib: Participants will receive oral tablets of vistusertib as stated in arm description.
Olaparib: Participants will receive oral tablets of olaparib as stated in arm description.
Oleclumab: Participants will receive IV infusion of oleclumab as stated in arm description.
Trastuzumab deruxtecan: Participants will receive IV infusion of trastuzumab deruxtecan as stated in arm description.
Cediranib: Participants will receive oral tablets of cediranib as stated in arm description.
Study summary
This is an open-label, multi-centre, umbrella Phase II study in participants with metastatic NSCLC who have progressed on an anti-PD-1/PD-L1 containing therapy. This study is modular in design, allowing initial assessment of the efficacy, safety, and tolerability of multiple treatment arms.
Eligibility
Primary outcome measure(s)
- Percentage of Participants With Objective Response Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) — Baseline (<=28 days before treatment), then every 6 weeks for 24 weeks from Cycle 1 Day 1, then every 8 weeks (every 9 weeks in Module 6) until disease progression or 90 days after study drug discontinuation (approximately 2 years)
Objective response was defined as participants with a confirmed investigator-assessed response complete response (CR) or partial response (PR) based on RECIST v 1.1. The CR is defined as disappearance of all target (TL) and non-target lesions (NTL), and any pathological lymph node (whether target or nontarget) must have reduction in short axis to \<10 mm. The PR is defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum diameters, as long as criteria for progressive disease (PD) are not met. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from date of first documentation. Percentage of participants with objective response was reported.
Trial sites (45)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Duarte | California | |
| Research Site | Fullerton | California | |
| Research Site | La Jolla | California | |
| Research Site | Los Angeles | California | |
| Research Site | Washington D.C. | District of Columbia | |
| Research Site | Chicago | Illinois | |
| Research Site | Baltimore | Maryland | |
| Research Site | Baltimore | Maryland | |
| Research Site | Boston | Massachusetts | |
| Research Site | St Louis | Missouri | |
| Research Site | New York | New York | |
| Research Site | Philadelphia | Pennsylvania | |
| Research Site | Pittsburgh | Pennsylvania | |
| Research Site | Nashville | Tennessee | |
| Research Site | Nashville | Tennessee | |
| Research Site | Houston | Texas | |
| Research Site | Fairfax | Virginia | |
| Research Site | Innsbruck | Austria | |
| Research Site | Salzburg | Austria | |
| Research Site | Vienna | Austria | |
| Research Site | Vienna | Austria | |
| Research Site | Edmonton | Alberta | |
| Research Site | Brampton | Ontario | |
| Research Site | Ottawa | Ontario | |
| Research Site | Toronto | Ontario | |
| Research Site | Montreal | Quebec | |
| Research Site | Bordeaux | France | |
| Research Site | Nantes | France | |
| Research Site | Paris | France | |
| Research Site | Villejuif | France | |
| Research Site | Berlin | Germany | |
| Research Site | Esslingen a.N. | Germany | |
| Research Site | Großhansdorf | Germany | |
| Research Site | Heidelberg | Germany | |
| Research Site | Haifa | Israel | |
| Research Site | Kfar Saba | Israel | |
| Research Site | Petah Tikva | Israel | |
| Research Site | Ramat Gan | Israel | |
| Research Site | Seoul | South Korea | |
| Research Site | Seoul | South Korea |
+ 5 more sites — see the full list on the official registry below.
On this site
📄 Imfinzi (durvalumab) drug profile → 📄 Lynparza (olaparib) drug profile → 📄 Enhertu (trastuzumab deruxtecan) drug profile →More AstraZeneca trials in Canada
Other trials for the same condition
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 NCT03334617 on ClinicalTrials.gov ↗ ← All trials in Canada