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Efficacy and Safety of PVT-1 Treatment in Patients With Advanced Non-Small Cell Lung Cancer

NCT04840004 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-04-05

No results posted yet for this study

Summary

Lung cancer is one of the most common causes of cancer death worldwide. It is projected that the vast majority, approximately 80% -85% of all lung cancer diagnosis is Non-Small Cell Lung Cancer (NSCLC). Although there are significant improvements in the treatment of Lung Cancer in recent years, there is still an unmet medical need for a specific population which has advanced NSCLC and mostly is refractory to existing treatments.

In NSCLC the molecular profile is important to direct the treatment. Specifically, for cases with an EGFR+, ALK+, ROS1+ or PD1/PDL1+ molecular profile, targeted treatments are available. PVT-1 is a safe, orally administrable and well-tolerated drug directed against a specific therapeutic target of cancer cells what has demonstrated efficacy in NSCLC with a molecular profile EGFR-, ALK-, ROS1- and refractory to anti-PD1 / PDL1, in last line, which also represents the highest percentage of patients and with the highest chances of cancer progression with currently available treatments.

Conditions

Interventions

DRUG

PVT-1

Since there is no specific dose range is available for testing the anti-tumor effects of PVT-1 in clinical trials settings, in the present study the dose of PVT-1 will be up-titrated 250/160/160 mg to maximum 1000/640/640 mg as described in study methodology section.

Sponsors & Collaborators

  • ECONiX Araştırma Analiz ve Danışmanlık A.Ş.

    collaborator INDUSTRY

  • PlusVitech S.L.

    lead OTHER

Principal Investigators

  • Sahin Lacin · Yeditepe University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04840004 on ClinicalTrials.gov