ERAS-007 for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UC Los Angeles, Santa Monica, CANon-Small Cell Lung CancerERAS-007 - Drug
Eligibility
18 - 99
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the safety and effectiveness of two drugs, ERAS-007 and ERAS-601, when used in combination with other cancer therapies to treat advanced non-small cell lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 6 Secondary · Reporting Duration: Assessed up to 24 months from time of first dose

Month 24
Adverse Events
Duration of Response (DOR)
Objective Response Rate (ORR)
Day 22
Area under the curve
Dose Limiting Toxicities (DLT)
Half-life
Maximum Tolerated Dose (MTD)
Plasma concentration (Cmax)
Recommended Dose (RD)
Time to achieve Cmax (Tmax)

Trial Safety

Trial Design

8 Treatment Groups

Dose Expansion (Part 2): ERAS-007 QW plus osimertinib
1 of 8
Dose Escalation (Part 1): ERAS-007 QW plus osimertinib
1 of 8
Dose Expansion (Part 4): ERAS-007 plus osimertinib
1 of 8
Dose Expansion (Part 5): ERAS-007 plus sotorasib
1 of 8
Dose Escalation (Part 1): ERAS-007 plus osimertinib
1 of 8
Dose Escalation (Part 3): ERAS-601 plus sotorasib
1 of 8
Dose Expansion (Part 6): ERAS-601 plus sotorasib
1 of 8
Dose Escalation (Part 2): ERAS-007 plus sotorasib
1 of 8

Experimental Treatment

200 Total Participants · 8 Treatment Groups

Primary Treatment: ERAS-007 · No Placebo Group · Phase 1

Dose Expansion (Part 2): ERAS-007 QW plus osimertinibExperimental Group · 2 Interventions: osimertinib, ERAS-007 · Intervention Types: Drug, Drug
Dose Escalation (Part 1): ERAS-007 QW plus osimertinibExperimental Group · 2 Interventions: osimertinib, ERAS-007 · Intervention Types: Drug, Drug
Dose Expansion (Part 4): ERAS-007 plus osimertinibExperimental Group · 2 Interventions: ERAS-007, Osimertinib · Intervention Types: Drug, Drug
Dose Expansion (Part 5): ERAS-007 plus sotorasibExperimental Group · 2 Interventions: ERAS-007, Sotorasib · Intervention Types: Drug, Drug
Dose Escalation (Part 1): ERAS-007 plus osimertinibExperimental Group · 2 Interventions: ERAS-007, Osimertinib · Intervention Types: Drug, Drug
Dose Escalation (Part 3): ERAS-601 plus sotorasibExperimental Group · 2 Interventions: Sotorasib, ERAS-601 · Intervention Types: Drug, Drug
Dose Expansion (Part 6): ERAS-601 plus sotorasibExperimental Group · 2 Interventions: Sotorasib, ERAS-601 · Intervention Types: Drug, Drug
Dose Escalation (Part 2): ERAS-007 plus sotorasibExperimental Group · 2 Interventions: ERAS-007, Sotorasib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
FDA approved
Osimertinib
FDA approved
Sotorasib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: assessed up to 24 months from time of first dose

Who is running the clinical trial?

Erasca, Inc.Lead Sponsor
5 Previous Clinical Trials
690 Total Patients Enrolled
Kimberly Komatsubara, M.D.Study DirectorSenior Medical Director
1 Previous Clinical Trials
200 Total Patients Enrolled
Joyce AntalStudy DirectorSenior Director, Clinical Development

Eligibility Criteria

Age 18 - 99 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your bone marrow and organs are working properly.

Frequently Asked Questions

To what conditions is ERAS-007 prescribed?

"ERAS-007 has been instrumental in treating previous platinum based therapy, therapeutic process and one prior systemic therapy." - Anonymous Online Contributor

Unverified Answer

What tangible goals are being sought through this research?

"As part of the timespan from Day 1 to Day 22, this medical trial's primary outcome is a determination of Maximum Tolerated Dose (MTD). Other associated outcomes are Duration of Response (DOR), Plasma concentration (Cmax) and Time to achieve Cmax (Tmax), all defined according to RECIST version 1.1." - Anonymous Online Contributor

Unverified Answer

In what quantity of sites is this investigation being conducted?

"11 medical facilities are currently enrolling patients, including the Dana Farber Research Institute in Boston, University of Colorado in Aurora and UC Los Angeles in Santa Monica. There are also numerous additional sites." - Anonymous Online Contributor

Unverified Answer

What is the aggregate sum of participants engaged in this experiment?

"To move forward with the trial, 200 qualified individuals must be enrolled. Those wishing to take part can do so at Dana Farber Research Institute in Boston or University of Colorado in Aurora." - Anonymous Online Contributor

Unverified Answer

Are there any available slots for participants in this research investigation?

"As per information found on clinicaltrials.gov, this research study is actively looking for participants with the original posting date of September 2nd 2021 and last update noted as August 4th 2022." - Anonymous Online Contributor

Unverified Answer

Are participants of 85 years or older being accepted into this research project?

"All potential participants must meet the specified age requirement of 18 to 99. Moreover, there are 43 studies for minors under 18 and 2012 studies available specifically targeting seniors above 65 years old." - Anonymous Online Contributor

Unverified Answer

What prerequisites must an individual meet to qualify for this research endeavor?

"This ongoing research study is currently recruiting 200 participants between the ages of 18 and 99 years-old who have been diagnosed with non-small cell lung carcinoma. Prospective candidates must be willing to provide written informed consent, demonstrate evidence of an EGFR mutation or KRAS G12C mutation, possess measurable disease based on RECIST v1.1 criteria, exhibit adequate bone marrow and organ function, hold a ECOG performance status score of 0 or 1, agree to attend all protocol visits and assessments as required by the trial regulations, and prove they can swallow oral medication." - Anonymous Online Contributor

Unverified Answer

What further investigations have been carried out regarding ERAS-007?

"ERAS-007 is currently being investigated in 111 separate clinical trials, 18 of which are at the final stage. Despite most of these studies centred around Uniondale, New York, over 6000 locations worldwide are conducting research into this medication." - Anonymous Online Contributor

Unverified Answer

Is this investigation innovative in its approach?

"Currently, 111 studies pertaining to ERAS-007 are being conducted around the world. These trials span 51 countries and 1175 cities, with AstraZeneca sponsoring 35 of them since 2013 - beginning with a Phase 1 & 2 trial involving 603 people." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.