701 Participants Needed

Lazertinib + Amivantamab for Non-Small Cell Lung Cancer

(Chrysalis-2 Trial)

Recruiting at 101 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Janssen Research & Development, LLC
Must be taking: Direct oral anticoagulant
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Lazertinib and Amivantamab for patients with advanced lung cancer with specific mutations. Lazertinib stops cancer cell growth, while Amivantamab helps the immune system kill these cells.

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, you should discuss your current medications with the study team to ensure they don't interfere with the trial treatments.

Is the combination of Lazertinib and Amivantamab safe for humans?

The combination of Lazertinib and Amivantamab has been tested in clinical trials for non-small cell lung cancer, and the safety profile was generally consistent with previous experiences of each drug alone, with only 4% of patients experiencing severe side effects. No new safety concerns were identified.12345

What makes the drug combination of Lazertinib and Amivantamab unique for treating non-small cell lung cancer?

The combination of Lazertinib and Amivantamab is unique because it targets both EGFR and MET mutations, which are common in non-small cell lung cancer, and is effective even after resistance to other treatments like osimertinib. This combination offers a novel approach by using a bispecific antibody (Amivantamab) and a third-generation EGFR inhibitor (Lazertinib) to improve outcomes for patients who have relapsed on standard therapies.14567

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

Research shows that the combination of Lazertinib and Amivantamab is effective in treating non-small cell lung cancer, especially in patients who have relapsed after using osimertinib. In studies, this combination demonstrated antitumor activity and improved response rates, with some patients experiencing a median progression-free survival of up to 11.1 months.14567

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 non-small cell lung cancer (NSCLC) that has specific EGFR mutations. Participants may have had previous treatments like chemotherapy or EGFR inhibitors, but must not have uncontrolled illnesses, active infections, severe gastrointestinal issues, or untreated brain metastases. They should be able to swallow pills and comply with study requirements.

Inclusion Criteria

A woman of childbearing potential: Must have a negative serum beta human chorionic gonadotropin at screening; Must agree not to breast-feed during the study and for 6 months after the last dose of study intervention. (Enrollment is not allowed even if a woman who is breast-feeding stops breast-feeding); Must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study intervention
I am fully active or restricted in physically strenuous activity but can do light work.
I have NSCLC with an EGFR mutation, it's spread, and I've tried all treatment options.
See 8 more

Exclusion Criteria

I do not have any uncontrolled illnesses or conditions that would interfere with the study.
I have brain or CNS metastases that haven't been treated, but I might be stable after therapy.
Side effects from my previous cancer treatment have mostly gone away.
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 Lazertinib and Amivantamab in various combinations, with some cohorts also receiving platinum-doublet chemotherapy.

Up to 2.5 years
Every 7 days for the first 28 days, then every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2.5 years

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Amivantamab
  • Carboplatin
  • Lazertinib
  • Pemetrexed
Trial Overview The trial is testing Lazertinib alone or combined with Amivantamab in NSCLC patients. It aims to find the safest dose when used together and assess how well they work against tumors with certain EGFR mutations. Some will also receive standard chemotherapy drugs Carboplatin and Pemetrexed.
How Is the Trial Designed?
9Treatment groups
Experimental Treatment
Group I: Phase 1b (expansion) Cohort F: Amivantamab MonotherapyExperimental Treatment1 Intervention
Group II: Phase 1b (expansion) Cohort E: Lazertinib and AmivantamabExperimental Treatment2 Interventions
Group III: Phase 1b (expansion) Cohort D: Lazertinib and AmivantamabExperimental Treatment2 Interventions
Group IV: Phase 1b (expansion) Cohort C: Lazertinib and AmivantamabExperimental Treatment2 Interventions
Group V: Phase 1b (expansion) Cohort B: Lazertinib and AmivantamabExperimental Treatment2 Interventions
Group VI: Phase 1b (expansion) Cohort A: Lazertinib and AmivantamabExperimental Treatment2 Interventions
Group VII: Phase 1b (combination): Lazertinib, Amivantamab and Platinum-doublet Chemotherapy (LACP)Experimental Treatment4 Interventions
Group VIII: Phase 1b (combination): Lazertinib and AmivantamabExperimental Treatment2 Interventions
Group IX: Phase 1 (monotherapy dose escalation): LazertinibExperimental Treatment1 Intervention

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

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Approved in United States as Rybrevant for:
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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

The ongoing CHRYSALIS study shows that the combination of amivantamab, an EGFR-MET bispecific antibody, and lazertinib, a third-generation EGFR TKI, is effective in treating both treatment-naive patients and those who have relapsed after osimertinib.
The MARIPOSA study is a phase 3 trial designed to compare the safety and efficacy of the amivantamab and lazertinib combination therapy against single-agent osimertinib, aiming to improve first-line treatment outcomes for patients with EGFR-mutant non-small-cell lung cancer.
MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small-cell lung cancer.Cho, BC., Felip, E., Hayashi, H., et al.[2022]
In a phase III trial involving 657 patients with advanced EGFR-mutated non-small-cell lung cancer, both amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy significantly improved progression-free survival (PFS) compared to standard chemotherapy, with median PFS of 6.3 and 8.3 months versus 4.2 months, respectively.
The combination therapies also showed a higher objective response rate (64% and 63% for amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy, respectively) compared to chemotherapy (36%), although the amivantamab-lazertinib-chemotherapy regimen had more hematologic adverse events.
Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study.Passaro, A., Wang, J., Wang, Y., et al.[2023]
The combination of amivantamab and lazertinib showed a 36% overall response rate in patients with EGFR-mutant non-small cell lung cancer who had progressed on previous treatments, indicating potential efficacy in a challenging treatment setting.
The safety profile of the combination therapy was consistent with previous studies, with only 4% of patients experiencing severe side effects, suggesting that this treatment may be safe for patients who are chemotherapy naive.
Amivantamab plus lazertinib in osimertinib-relapsed EGFR-mutant advanced non-small cell lung cancer: a phase 1 trial.Cho, BC., Kim, DW., Spira, AI., et al.[2023]

Citations

Amivantamab plus Lazertinib Is Efficacious in Non-Small Cell Lung Cancer. [2023]
MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small-cell lung cancer. [2022]
Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study. [2023]
Amivantamab plus lazertinib in osimertinib-relapsed EGFR-mutant advanced non-small cell lung cancer: a phase 1 trial. [2023]
Amivantamab in the Treatment of Metastatic NSCLC: Patient Selection and Special Considerations. [2022]
Amivantamab: First Approval. [2021]
Amivantamab: A New Hope in Targeting Non-small Cell Lung Cancer. [2023]
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