480 Participants Needed

Amivantamab Combinations for Non-Small Cell Lung Cancer

(COPERNICUS Trial)

Recruiting at 122 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Janssen Research & Development, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that any side effects from previous cancer treatments must be resolved before starting the trial.

Is Amivantamab safe for humans?

Amivantamab, also known as Rybrevant, has been approved for use in treating certain types of non-small cell lung cancer, and early studies have shown it to be safe when combined with chemotherapy. However, more data is needed to fully understand its safety profile.12345

What makes the drug amivantamab unique for treating non-small cell lung cancer?

Amivantamab is unique because it is a bispecific antibody that targets both EGFR and MET, specifically designed for non-small cell lung cancer with EGFR Exon 20 insertion mutations, especially after other treatments like platinum-based chemotherapy have failed. This dual-targeting approach is different from many other treatments that typically focus on a single target.12346

What data supports the effectiveness of the drug Amivantamab for treating non-small cell lung cancer?

Amivantamab has been approved for treating non-small cell lung cancer (NSCLC) with specific genetic mutations after other treatments have failed, showing it can be effective in these cases. It has shown safety and antitumor activity when combined with chemotherapy drugs like carboplatin and pemetrexed.12345

Who Is on the Research Team?

JR

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) that can't be treated with surgery. Participants must have specific EGFR mutations, at least one measurable lesion not previously irradiated, and should have recovered from previous cancer treatments to a certain extent. They need to be in good physical condition as measured by ECOG standards.

Inclusion Criteria

My cancer has a specific EGFR mutation (Ex19del or L858R).
My lung cancer cannot be cured with surgery or radiation.
I am fully active or can carry out light work.
See 2 more

Exclusion Criteria

I haven't taken any experimental drugs recently or am not in a study now.
I have cancer pain that is not managed well.
I have a history of lung inflammation not caused by infection.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Amivantamab in combination with Lazertinib or chemotherapy in cycles until disease progression or other criteria are met

Up to 4 years and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Amivantamab
  • Chemotherapy: Carboplatin
  • Chemotherapy: Pemetrexed
Trial Overview The study tests the effectiveness of amivantamab combined either with lazertinib or platinum-based chemotherapy (pemetrexed and carboplatin) on NSCLC patients who have specific EGFR mutations. It aims to see how well these combinations control tumor growth.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Cohort 2: Amivantamab and ChemotherapyExperimental Treatment3 Interventions
Group II: Cohort 1: Amivantamab and LazertinibExperimental Treatment2 Interventions

Amivantamab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Rybrevant for:
🇪🇺
Approved in European Union as Rybrevant for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

Amivantamab, approved for treating non-small cell lung cancer with specific genetic mutations, works by targeting two pathways: the epithelial growth factor receptor and mesenchymal epithelial transition factor, enhancing the immune response against cancer cells.
Preclinical studies indicate that Amivantamab effectively inhibits cancer cell growth in models with exon20 insertions of the epithelial growth factor receptor, suggesting its potential as a targeted therapy for this specific patient population.
Amivantamab: A New Hope in Targeting Non-small Cell Lung Cancer.Billowria, K., Das Gupta, G., Chawla, PA.[2023]
In a phase 3 trial involving 308 patients with advanced non-small-cell lung cancer (NSCLC) and EGFR exon 20 insertions, the combination of amivantamab and chemotherapy significantly improved progression-free survival compared to chemotherapy alone, with a median of 11.4 months versus 6.7 months.
The combination therapy also showed a higher response rate, with 73% of patients achieving a complete or partial response compared to 47% in the chemotherapy-only group, indicating that amivantamab enhances the effectiveness of standard chemotherapy in this patient population.
Amivantamab plus Chemotherapy in NSCLC with EGFR Exon 20 Insertions.Zhou, C., Tang, KJ., Cho, BC., et al.[2023]
Amivantamab is a bispecific monoclonal antibody that targets both EGFR and MET, specifically developed for treating non-small cell lung cancer (NSCLC) with EGFR Exon 20 insertion mutations.
It received its first approval in the USA on May 21, 2021, for adult patients with advanced NSCLC who have progressed after platinum-based chemotherapy, and is currently in preregistration in multiple countries including the EU and Japan.
Amivantamab: First Approval.Syed, YY.[2021]

Citations

Amivantamab: A New Hope in Targeting Non-small Cell Lung Cancer. [2023]
Amivantamab plus Lazertinib Is Efficacious in Non-Small Cell Lung Cancer. [2023]
Amivantamab plus Chemotherapy in NSCLC with EGFR Exon 20 Insertions. [2023]
Amivantamab: First Approval. [2021]
Amivantamab-Vmjw: A Novel Treatment for Patients with NSCLC Harboring EGFR Exon 20 Insertion Mutation after Progression on Platinum-Based Chemotherapy. [2023]
BRIEF REPORT: Real-world efficacy and safety of amivantamab for EGFR-mutant non-small cell lung cancer (NSCLC). [2023]
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