Expansion Cohort for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Non-Small Cell Lung CancerTipifarnib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a Phase 1a/b, multicenter, open-label, dose escalation (1a) and dose expansion (1b) study. The purpose of this study is to measure safety, tolerability, and preliminary efficacy with the combination of tipifarnib with osimertinib in patients with advanced/metastatic EGFR-mutated non-small cell lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Study Objectives

4 Primary · 5 Secondary · Reporting Duration: Assessed every 8 weeks for the first year and every 12 weeks thereafter up to end of study at approximately 2 years

Year 2
To evaluate the efficacy of tipifarnib in combination with osimertinib
Day 28
For Dose Escalation determine a safe and tolerable Phase 2 dose of tipifarnib when used in combination with osimertinib
Day 28
To study pharmacokinetics (PK) of tipifarnib and osimertinib in combination
Year 5
For Dose Escalation characterize the safety of the combination DLTs will be listed for patients who complete the evaluation period for DLT
Day 28
For Dose Expansion characterize the safety profile of tipifarnib in combination with osimertinib as per NCI CTCAE v5.0 using the percentage of patients who discontinue the combination for related adverse events
Year 2
To evaluate circulating tumor DNA (ctDNA) as an indicator or response in both ctDNA positive and negative patients by changes in genetic alterations
To evaluate circulating tumor DNA (ctDNA) clearance rates for patients positive at baseline
To evaluate circulating tumor DNA (ctDNA) time to detection changes associated with disease progression
Year 2
For Dose Expansion characterize the safety profile of tipifarnib in combination with osimertinib as per NCI CTCAE v5.0 using descriptive statistics of adverse events

Trial Safety

Trial Design

2 Treatment Groups

Expansion Cohort
1 of 2
Escalation Cohort
1 of 2

Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: Expansion Cohort · No Placebo Group · Phase 1

Expansion CohortExperimental Group · 2 Interventions: Tipifarnib, Osimertinib · Intervention Types: Drug, Drug
Escalation CohortExperimental Group · 2 Interventions: Tipifarnib, Osimertinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tipifarnib
2000
Completed Phase 3
~710
Osimertinib
2017
Completed Phase 4
~770

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: assessed every 8 weeks for the first year and every 12 weeks thereafter up to end of study at approximately 2 years

Who is running the clinical trial?

Kura Oncology, Inc.Lead Sponsor
10 Previous Clinical Trials
793 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have attained the legal age of majority and are eligible to provide informed consent.
You have a histologically or cytologically validated stage IIIB (locally-advanced) or IV (metastatic) adenocarcinoma of the lung.
You have not received treatment for EGFR-mutated, locally advanced/metastatic non-small cell lung cancer (NSCLC) and are osimertinib naïve for NSCLC.
You have a quantifiable condition conforming to the selection standards of RECIST v1.1.
Laboratory results demonstrate adequate organ functioning.
The tumor possesses an Ex19del or Ex21-L858R alteration, discernible in tissue samples or ctDNA.
You have a good performance status, no significant changes in health over the last two weeks and an estimated lifespan of at least three months.