ORIC-114 + Amivantamab for Non-Small Cell Lung Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this study is to establish the recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-114 in combination with subcutaneous (SC) amivantamab in patients with advanced or metastatic NSCLC harboring an EGFR exon 20 insertion mutation.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the drug combination ORIC-114 and Amivantamab for treating non-small cell lung cancer?
Amivantamab has shown effectiveness in treating non-small cell lung cancer (NSCLC) with specific genetic mutations, particularly when combined with other drugs like lazertinib or chemotherapy. It has been approved for use in patients with certain mutations who have not responded to previous treatments, demonstrating significant response rates and progression-free survival in clinical trials.12345
How does the drug ORIC-114 + Amivantamab differ from other treatments for non-small cell lung cancer?
The combination of ORIC-114 and Amivantamab is unique because Amivantamab is a bispecific antibody that targets both EGFR and MET, specifically designed for non-small cell lung cancer with EGFR exon 20 insertion mutations, which are typically resistant to other treatments. This combination aims to provide a new option for patients who have progressed after standard chemotherapy.23467
Research Team
Pratik S. Multani, MD, MS
Principal Investigator
ORIC Pharmaceuticals
Eligibility Criteria
This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific mutation called EGFR exon 20 insertion. Participants should have this type of lung cancer and be in good enough health to receive the treatments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive ORIC-114 in combination with amivantamab to determine the recommended phase 2 dose (RP2D) through a 3+3 dose escalation design
Dose Expansion
Participants receive two potential ORIC-114 dose levels in combination with amivantamab to further assess safety and preliminary antitumor activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Amivantamab
- ORIC-114
Find a Clinic Near You
Who Is Running the Clinical Trial?
ORIC Pharmaceuticals
Lead Sponsor
Janssen Research and Development LLC
Collaborator