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Monoclonal Antibodies

Amivantamab Combinations for Non-Small Cell Lung Cancer (COPERNICUS Trial)

Phase 2

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy

Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated

Must not have

Medical history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis

Had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before the first dose of anticancer treatments or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years and 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see how effective a drug called amivantamab is when given under the skin along with lazertinib or chemotherapy for patients with a specific type of lung cancer caused by a

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions at the injection site, fatigue, rash, muscle pain from amivantamab; nausea and hair loss from chemotherapy; and liver enzyme changes due to lazertinib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer cannot be cured with surgery or radiation.

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I have a tumor that can be measured and hasn't been treated with radiation.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of lung inflammation not caused by infection.

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I haven't had major surgery or significant injury in the last 4 weeks, or if I did, I'm fully recovered.

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I do not have another cancer that could affect this study's treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

Clinical Benefit Rate (CBR)

Cohort 1: Number of Participants Reporting Compliance with Anticoagulation Medications

Duration of Response (DOR)

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2: Amivantamab and ChemotherapyExperimental Treatment3 Interventions

Participants will receive Amivantamab SC injection in combination with chemotherapy (carboplatin and pemetrexed) intravenous (IV) infusion in 21-day cycles until disease progression, withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first.

Group II: Cohort 1: Amivantamab and LazertinibExperimental Treatment2 Interventions

Participants will receive Amivantamab subcutaneous (SC) injection in combination with Lazertinib orally in 28-day cycles until disease progression, withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lazertinib

2021

Completed Phase 2

~770

0 / 6Eligibility criteria met