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Atezolizumab

Phase 2

Non-Small Cell Lung Cancer | Small molecule | Oncology |IQVIA Holdings, Inc.|Last Updated: Mar 1, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment43
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03976518Atezolizumab in Advanced Non-small Cell Lung Cancer With Rare Histologies (CHANCE Trial)PHASE2 COMPLETED 43May 7, 2019Feb 12, 2024Mar 1, 202410 Italy
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Study Endpoints
Primary Endpoints
Disease Control Rate (DCR)
From the start of treatment (baseline) to the progression of disease (PD) or trial discontinuation whichever occurs first, assessed up to 24 months.

Proportion of patients presenting Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) based on the Investigator's assessment according to standard RECIST criteria v.1.1.

Secondary Endpoints
Treatment Safety based on Adverse Events Frequency and Safety
From the treatment start to 90 days after the administration of the last treatment dose. The outcome is assessed up to a maximum of 27 months.
Objective Response Rate (ORR)
From the start of treatment (baseline) to the progression or stability of disease assessed up to 24 months.
Overall Survival (OS)
From the date of enrollment to the date of death from any cause. The survival follow-up will continue until 6 months after the last subject receives the last dose of atezolizumab
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ATEZOLIZUMABEXPERIMENTALAtezolizumab will be administered at a flat dose of 1200 mg by intravenous route. Atezolizumab will be delivered in 250-mL 0.9% NaCl (sodium chloride) intravenous (IV) infusion bags. The administration will be repeated every 3 weeks (21 \[± 3\] days). The initial dose will be delivered over 60 (± 15) minutes. In case the first infusion is tolerated without any infusion-associated AEs the second infusion may be delivered over 30 (± 10) minutes. If the second 30 minutes infusion is well tolerated all the subsequent infusions may be administered over 30 (± 10) minutes. The treatment will be continued until disease progression, intolerable toxicity, patient refusal or Investigator's decision or any criterion for withdrawal from the trial or trial drug is fulfilled.
Interventions
NameTypeDescription
AtezolizumabDRUGAtezolizumab will be administered on Day 1 every 21 days (+/- 3 days).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Locally advanced, relapsed or metastatic non-small cell lung cancer (NSCLC) - stage IIIB/IV according to 7th International Association for the Study of Lung Cancer (IASLC) classification * Histologically confirmed diagnosis of non-small cell lung cancer (NSCLC) with rare histo...

Countries:Italy
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Competitive Landscape -Non-Small Cell Lung Cancer 406 trials
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Eli Lilly and CompanyLLY19PHASE3Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab
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Pfizer Inc.PFE21PHASE3Lorlatinib, Crizotinib, Avelumab, Lorlatanib, Talazoparib
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Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib, Crizotinib, AB-106
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Pembrolizumab, Docetaxel, Rina-S, GEN1042
Incyte CorporationINCY1PHASE3Retifanlimab, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel
Regeneron Pharmaceuticals, Inc.REGN6PHASE2cemiplimab, Platinum Doublet, fianlimab, Pemetrexed, Paclitaxel
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3Tislelizumab, Cisplatin, Paclitaxel, Pemetrexed Disodium, Carboplatin
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