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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.|Trials Updated: Jul 13, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment540

FDA Designations

No designations recorded

Tavocept in combination with cisplatin and either docetaxel or paclitaxel clinical trials

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 544 trials

Top 20 of 90 competitors

CompanyTickerTrialsLead PhaseDrugs
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Frequently asked questions about Tavocept in combination with cisplatin and either docetaxel or paclitaxel

What is Tavocept used for in non-small cell lung cancer?

Tavocept is being studied in combination with cisplatin and either docetaxel or paclitaxel for patients with newly diagnosed or relapsed advanced primary adenocarcinoma of the lung, a form of non-small cell lung cancer. It is an investigational small molecule developed by Lantern Pharma Inc. (LTRN) and has reached Phase 3 testing.

Who is developing Tavocept?

Tavocept is being developed by Lantern Pharma Inc., which trades under the ticker LTRN. The company is advancing the small molecule in combination with cisplatin and either docetaxel or paclitaxel for advanced primary adenocarcinoma of the lung, a non-small cell lung cancer indication.

What phase is Tavocept in?

Tavocept is in Phase 3 development. A randomized, double-blind, placebo-controlled Phase 3 trial has been completed, and no trials of the combination regimen are currently active. Tavocept is investigational and has not been established as an approved therapy for non-small cell lung cancer.

What clinical trial has studied Tavocept in non-small cell lung cancer?

Tavocept has been evaluated in the Phase 3 trial NCT00966914, titled a 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. The trial enrolled 540 patients across the United States, Bulgaria, Poland, Romania, Russia, and Ukraine, and it is completed.

Is Tavocept the same as BNP7787?

Yes. Tavocept is also known as BNP7787. The combination regimen referenced in its clinical program is Tavocept (BNP7787) in combination with cisplatin and either docetaxel or paclitaxel, so searches using either name refer to the same investigational agent developed by Lantern Pharma Inc. (LTRN).

How was the Phase 3 Tavocept trial designed?

The Phase 3 trial NCT00966914 was randomized, double-blind, and placebo-controlled, enrolling 540 patients aged 18 years and older of all sexes. It compared Tavocept against placebo in patients with newly diagnosed or relapsed advanced primary adenocarcinoma of the lung who were treated with docetaxel or paclitaxel plus cisplatin. The study is completed.