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Durvalumab

Phase 4FDA approved

Non Small Cell Lung Cancer | Monoclonal antibody | Other |Bayer AG|Trials Updated: Nov 18, 2025

Durvalumab development status

FDA approval on record May 1, 2017 as Imfinzi
Approval holderAstrazeneca Uk Ltd
ApplicationBLA761069
Highest phase Phase 4 run by AstraZeneca (NCT04078152)
Phase scored for BAYRYPhase 1
Registered trials 292 across 119 sponsors since Jan 2014

Label indication IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: • in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR)… FDA label

Durvalumab target and mechanism

ModalityMonoclonal antibody

Also known as Imfinzi

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment11

FDA Designations

No designations recorded

Durvalumab clinical trials

Durvalumab · 1 trial · 1 indication

Phase 1 1
NCT04895579Lung Cancer With Copanlisib and DurvalumabNon Small Cell Lung Cancer
COMPLETED11 Analytics
PHASE1COMPLETED
Lung Cancer With Copanlisib and Durvalumab
Non Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Dose Limiting Toxicity
28 days

The number of dose limiting toxicities will be counted for each cohort.

Secondary Endpoints

Objective Response Rate
approximately 10 years
Progression-Free Survival
approximately 10 years
Duration of Response
approximately 10 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Copanlisib (30-60mg iv)EXPERIMENTALPatients in the group will receive Durvalumab at 10mg/kg (IV infusion on days 1 and 15, q28 days or 1500mg day 1 q28d). They will also receive Copanlisib ranging from 30mg to 60mg (IV infusion on days 1 and 15, q 28 days).

Interventions

NameTypeDescription
DurvalumabDRUGDurvalumab will be delivered at 10mg/kg via IV infusion at days 1 and 15 every 28 days or 1500 mg on D1, q4w.
CopanlisibDRUGCopanlisib will be delivered at various doses (30-60mg/kg) via IV infusion at days 1 and 15 every 28 days.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Histologically confirmed NSCLC (e.g., adenocarcinoma, squamous cell) deemed unresectable or inoperable who have received concurrent chemoradiation. * Durvalumab will be started as consolidation therapy * Have at least one measurable lesion. * ECOG performance status ≤2. * Adeq...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 550 trials (matched to "Non Small Cell Lung Cancer")

Top 20 of 90 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK39PHASE3Pembrolizumab, Olaparib, Sacituzumab tirumotecan, Intismeran autogene, Pembrolizumab Berahyaluronidase alfa
Revolution Medicines, Inc.RVMD9PHASE3Daraxonrasib, Zoldonrasib, Elironrasib, RMC-5127
Eli Lilly and CompanyLLY18PHASE3Selpercatinib, Pemetrexed, Abemaciclib, Olomorasib, LY3537982
AbbVie, Inc.ABBV12PHASE3Telisotuzumab vedotin, ABBV-1480, Livmoniplimab, Budigalimab, Telisotuzumab Adizutecan
AstraZeneca PLCAZN69PHASE3Datopotamab deruxtecan, Durvalumab, Oleclumab, Monalizumab, Tremelimumab
Gilead Sciences, Inc.GILD7PHASE3Sacituzumab govitecan, Zimberelimab, Domvanalimab, Etrumadenant, TUB-040- Dose escalation
Bristol-Myers Squibb CompanyBMY24PHASE3Repotrectinib, Nivolumab, Pumitamig, Relatlimab, Adagrasib
Johnson & JohnsonJNJ19PHASE3Lazertinib, Amivantamab, JNJ-90301900, JNJ-86974680, Cetrelimab
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Pumitamig, BNT326, BNT116, BNT324
Pfizer Inc.PFE21PHASE3Lorlatinib, Crizotinib, Avelumab, Talazoparib, Axitinib
Amgen Inc.AMGN4PHASE3ABP 234, Sotorasib, Anvumetostat
Novartis AG Sponsored ADRNVS11PHASE3Opnurasib, TNO155, DKY709, Spartalizumab, KFA115
GSK plc Sponsored ADRGSK3PHASE3Dostarlimab, Belrestotug, Nelistotug, Cobolimab
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib
Summit Therapeutics IncSMMT2PHASE3Ivonescimab
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Rina-S, GEN1042
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib
Regeneron Pharmaceuticals, Inc.REGN7PHASE2Cemiplimab, Marlotamig, Fianlimab, REGN5093
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib
BeOne Medicines Ltd. Sponsored ADRONC7PHASE3Tislelizumab, BGB-A445, LBL-007, BGB-15025, BGB-43395
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