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.
- Non-Small Cell Lung Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 6 Secondary · Reporting Duration: Assessed up to 24 months from time of first dose
Trial Safety
Safety Progress
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 99 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you: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
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
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
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
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
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
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
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
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