A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC
* To evaluate the safety and tolerability of escalating doses of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with advanced non-small cell lung cancer (NSCLC). * To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 or ERAS-601 administered in combination with other cancer therapies. * To evaluate the antitumor activity of ERAS-007 or ERAS-601 in combination with other cancer therapies. * To evaluate the PK profiles of ERAS-007 or ERAS-601 and other cancer therapies when administered in combination.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 2 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jul 25, 2023 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Erasca, Inc.
- Interventions being studied
- Drug: ERAS-007; Drug: ERAS-601; Drug: Osimertinib; Drug: Sotorasib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Age ≥ 18 years.
- Willing and able to give written informed consent.
- Have histologically or cytologically confirmed NSCLC, with presence of EGFR mutation(s) sensitive to EGFR inhibitors, or KRAS G12C mutation.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Adequate bone marrow and organ function.
- Have ECOG performance status of 0 or 1.
- Willing to comply with all protocol-required visits, assessments, and procedures.
- Able to swallow oral medication.
- Concurrent treatment with any systemic anticancer therapy for NSCLC, including any approved or investigational agent.
- For participants with EGFRm NSCLC: prior therapy with a RAS, RAF, MEK, or ERK inhibitor.
- For participants with KRAS G12Cm NSCLC: prior therapy with a SHP2, ERK, or KRAS G12C inhibitor (depending on which cohort is being considered for enrollment).
- Palliative radiotherapy within 7 days of enrollment.
- History of unacceptable toxicity to treatment with osimertinib or sotorasib.
- Major surgery within the 28 days of enrollment.
- Unresolved toxicities from prior systemic therapy greater than NCI CTCAE grade 1 at time of enrollment, except for toxicities not considered a safety risk (eg, alopecia, vitiligo, and grade 2 neuropathy due to prior chemotherapy).
- History of another malignancy ≤5 years prior to first dose, except for patients who are disease-free for \>2 years after treatment with curative intent or who have carcinoma in situ.
- Symptomatic and unstable brain metastases, or spinal cord compression, except for patients who have completed definitive therapy (surgery or radiotherapy), are not on steroids, and have a stable neurologic status for a least 2 weeks after completion of the definitive therapy and steroids.
- History of or clinically active ILD, drug induced ILD, or radiation pneumonitis that required steroid treatment.
- Impaired cardiovascular function or clinically significant cardiovascular disease.
- History or current evidence of retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vein occlusion (RVO), or predisposing factors to RPED or RVO.
- Any evidence of severe or uncontrolled systemic disease or evidence of any other significant clinical disorder or laboratory finding that renders the patient inappropriate to participate in the study.
- Pregnant or breastfeeding women.
- Contraindication to osimertinib or sotorasib use as per local label.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- City of HopeDuarte, California
- UC Irvine, Chao Family Comprehensive Cancer CenterOrange, California
- UC Los AngelesSanta Monica, California
- University of ColoradoAurora, Colorado
- Massachusetts General HospitalBoston, Massachusetts
- Dana Farber Research InstituteBoston, Massachusetts
- Henry Ford Health SystemDetroit, Michigan
- Hackensack University Medical Center (John Theurer Cancer Center)Hackensack, New Jersey
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Sarah Cannon Research Institute (Tennessee Oncology)Nashville, Tennessee
- Virginia Cancer SpecialistsFairfax, Virginia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 25, 2023. Always confirm current availability with the study team.