A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC
a study on Lung Cancer Non-Small Cell Lung Cancer
Summary
- Eligibility
- for people ages 18-99 (full criteria)
- Location
- at Orange, California and other locations
- Dates
- study startedestimated completion
Description
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.
Official Title
A Phase 1b/2 Master Protocol of Agents Targeting the Mitogen-Activated Protein Kinase Pathway in Patients With Advanced Non-Small-Cell Lung Cancer
Details
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.
Keywords
Advanced Non-squamous Non-small-cell Lung Cancer EGFR epidermal growth factor receptor mutation biomarker NSCLC Tagrisso osimertinib ERK MAPK sotorasib Lumakras KRAS G12C SHP2 PTPN11 molecular alterations Kirsten rat sarcoma Non-small cell lung cancer Lung neoplasms Thoracic neoplasms ERAS-601 ERAS-007 Carcinoma, Non-Small-Cell Lung
Eligibility
You can join if…
Open to people ages 18-99
- 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.
You CAN'T join if...
- 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.
Locations
- UC Irvine, Chao Family Comprehensive Cancer Center
accepting new patients
Orange California 92868 United States - City of Hope
accepting new patients
Duarte California 91010 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Erasca, Inc.
- ID
- NCT04959981
- Phase
- Phase 1/2 research study
- Study Type
- Interventional
- Participants
- Expecting 200 study participants
- Last Updated
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