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Tavocept in combination with cisplatin and either docetaxel or paclitaxel

Phase 3

Non-small Cell Lung Cancer | Small molecule | Oncology |Lantern Pharma Inc.|Last Updated: Jul 13, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment540

FDA Designations

No designations recorded

Clinical trial landscape

Tavocept in combination with cisplatin and either docetaxel or paclitaxel · 1 trial · 1 indication

Phase 3 1
NCT00966914Phase 3 Study of Tavocept Versus Placebo in Patients With Newly Diagnosed or Relapsed Advanced Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus CisplatinNon-small Cell Lung Cancer
COMPLETED540 Analytics
PHASE3COMPLETED
Phase 3 Study of Tavocept Versus Placebo in Patients With Newly Diagnosed or Relapsed Advanced Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin
Non-small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Survival
throughout study

Secondary Endpoints

Progression Free Survival
Every 2 cycles during study treatment then every 6-8 weeks after going off study for up to 6 months, or until progression or initiation of further treatment
Incidence of 30% or greater decrease in the calculated creatinine clearance relatively to baseline
throughout the study
Incidence of NCI-CTCAE grade 2,3, or 4 anemia
throughout the study
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo in combination with cisplatin and either paclitaxel or docetaxel
Tavocept (BNP7787)ACTIVE_COMPARATORTavocept (BNP7787) in combination with cisplatin and either docetaxel or paclitaxel

Interventions

NameTypeDescription
Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxelDRUGPaclitaxel 200 mg/m2 IV or Docetaxel 75mg/m2 IV every 3 weeks plus Cisplatin 80 mg/m2 IV every 3weeks plus Tavocept(BNP7787) 18.4gm/m2 IV every 3 weeks
Placebo in combination with cisplatin and docetaxel or paclitaxelDRUGPaclitaxel 200 mg/m2 IV or Docetaxel 75mg/m2 IV every 3 weeks plus Cisplatin 80 mg/m2 IV every 3weeks plus Placebo IV every 3 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites42

Inclusion Criteria: * Confirmed histopathological diagnosis of inoperable advanced primary adenocarcinoma (including bronchioalveolar cell carcinoma) of the lung * No prior systemic treatment for non-small cell lung cancer including chemotherapy, immunotherapy, hormonal therapy, targeted therapies ...

Countries:United StatesBulgariaPolandRomaniaRussiaUkraine
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Competitive Landscape -Non-Small Cell Lung Cancer 387 trials