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Report for Clinical Trial NCT03496766

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

An Open Label Phase II Study of Tipifarnib in Advanced Squamous Non-small Cell Lung Cancer With HRAS Mutations

This Phase II study consists of 2 parts: 1) pre-screening phase and 2) treatment phase. The pre-screening phase will investigate the presence of HRAS mutations in subjects with a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (SQ-NSCLC). Subjects may participate in the pre-screening phase at initial diagnosis or following prior lines of therapy for SQ-NSCLC. The treatment phase will investigate the antitumor activity in terms of ORR of tipifarnib in subjects with locally advanced squamous non-small cell lung cancer (SQ-NSCLC) with HRAS mutations and for whom there is no curative therapy available.

NCT03496766 Non Small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: Tipifarnib

Description: Tipifarnib 600 mg will be administered until progression
Type: Drug
Group Labels: 1

Experimental Arm

Primary Outcomes

Description: To determine the antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, squamous non-small cell lung cancer (SQ-NSCLC) with HRAS mutations

Measure: Overall Response Rate

Time: From the first dose until progression disease, assessed from the first dose until the first assessment at week 6 from the first dose

Secondary Outcomes

Description: As there is a screening phase where HRAS mutations will be analyzed, the second outcome is to determine the frequency (%) of this mutation in the target population of this study

Measure: Frequency of HRAS mutations

Time: at the beginning of the study, day -7 to day 0

Description: Adverse events will be collected in all the patients in order to now the tolerability of the treatment

Measure: Tolerability as Incidence of Treatment-Emergent Adverse Events of Tipifarnib

Time: from the first dose of treatment until 30 days after the last dose of treatment

Purpose: Treatment

Allocation: N/A

Single Group Assignment

There is one SNP


1 T81C

Non Small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung Subject enrolment may proceed with information available on tumor HRAS status previously generated during the pre-screening phase, but all subjects must consent to provide tumor slides (or tumor tissue block) from a prior diagnostic biopsy for a retrospective testing of RAS gene status, including T81C polymorphism, and other potential biomarkers at a central facility. --- T81C ---

HPO Nodes