Lung Cancer Clinical Trial

A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC

Summary

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.

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Full Description

This is a Phase 1b/2, open-label, multicenter master protocol evaluating safety, tolerability, and antitumor activity of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with advanced NSCLC. The study will commence with the following dose escalation cohorts: ERAS-007 plus osimertinib in study participants with advanced NSCLC harboring epidermal growth factor receptor-sensitizing mutation(s) (EGFRm); ERAS-007 or ERAS-601 plus sotorasib in study participants with advanced NSCLC harboring Kirsten rat sarcoma G12C mutation (KRAS G12Cm). Dose expansion will follow and will evaluate ERAS-007 or ERAS-601 drug combinations administered at the RD identified from each respective dose escalation cohort in study participants with advanced EGFRm or KRAS G12Cm NSCLC.

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Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

200

Study ID:

NCT04959981

Recruitment Status:

Recruiting

Sponsor:

Erasca, Inc.

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There are 11 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
UC Irvine, Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
UC Los Angeles
Santa Monica California, 90404, United States
University of Colorado
Aurora Colorado, 80045, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana Farber Research Institute
Boston Massachusetts, 02215, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Hackensack University Medical Center (John Theurer Cancer Center)
Hackensack New Jersey, 07601, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Sarah Cannon Research Institute (Tennessee Oncology)
Nashville Tennessee, 37203, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

200

Study ID:

NCT04959981

Recruitment Status:

Recruiting

Sponsor:


Erasca, Inc.

How clear is this clinincal trial information?

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