What side effects are associated with this type of intervention?

Common treatments for NSCLC targeting EGFR, MET, and PD-1 include drugs like amivantamab, osimertinib, and pembrolizumab. Known side effects of these treatments can include rash, paronychia, and infusion-related reactions for EGFR inhibitors like amivantamab. MET inhibitors may cause peripheral edema and interstitial lung disease. PD-1 inhibitors such as pembrolizumab and cemiplimab can lead to immune-related adverse events like pneumonitis, colitis, hepatitis, and endocrinopathies. Additionally, fatigue, nausea, and decreased appetite are common across these therapies.

What prior FDA approvals exist?

Several FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) target EGFR and PD-1 pathways. For EGFR, drugs like Erlotinib and Necitumumab have been approved, with Necitumumab specifically used in combination with gemcitabine and cisplatin for metastatic squamous cell NSCLC. For PD-1, Cemiplimab has been approved for advanced NSCLC with PD-L1 expression of ≥50%, showing improved overall survival (OS) and progression-free survival (PFS) compared to chemotherapy. Pembrolizumab, another PD-1 inhibitor, has also been approved in combination with chemotherapy for advanced NSCLC, demonstrating significant improvements in OS and PFS.

What other types of research exist?

Promising alternatives to Amivantamab and Cetrelimab for NSCLC patients include: 1) Pembrolizumab (PD-1 inhibitor) combined with chemotherapy, which has shown improved overall survival in various PD-L1 expression categories. 2) Atezolizumab (PD-L1 inhibitor) combined with chemotherapy, particularly beneficial for patients with high PD-L1 expression. 3) Ramucirumab plus Pembrolizumab, which has shown improved overall survival in patients with progressive disease after initial immunotherapy. 4) Durvalumab plus Tremelimumab, particularly for patients with high tumor mutational burden. 5) Novel agents like Sintilimab and Tislelizumab, which have shown efficacy in combination with chemotherapy in clinical trials.

← Back to Search

Monoclonal Antibodies

Amivantamab + Cetrelimab for Non-Small Cell Lung Cancer (PolyDamas Trial)

Phase 1 & 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of two drugs, amivantamab and cetrelimab, in patients with a specific type of lung cancer. The treatment works by blocking cancer growth signals and helping the immune system fight the cancer. Amivantamab is a bispecific antibody that targets EGFR and MET, approved for treating non-small cell lung cancer with EGFR exon 20 insertion mutations.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer that has worsened after treatment with a specific type of medication called EGFR TKI and chemotherapy. Participants must be in good physical condition, have at least one measurable tumor not treated by radiation, and their cancer must have certain genetic changes known as EGFR exon19del or L858R mutations.

What is being tested?

The study is testing the combination of two drugs, Amivantamab and Cetrelimab, to find the best dose for Phase 2 trials and to see how well they work together against lung cancer that has specific genetic mutations and has resisted previous treatments.

What are the potential side effects?

Potential side effects from Amivantamab and Cetrelimab may include reactions where the drug enters the body (infusion-related), inflammation in various organs, fatigue, issues affecting skin or nails, muscle or joint pain. The exact side effects will vary between individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years 3 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

Phase 1: Number of Participants with Adverse events (AEs) by Severity

Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs)

Phase 2: Objective Response Rate

Secondary study objectives

Phase 1 and Phase 2: Number of Participants with AEs by Severity

Phase 1 and Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Parameters

Phase 2 : Duration of Response (DoR)

+3 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: Phase 2 (Dose Expansion)Experimental Treatment2 Interventions

Participants will receive amivantamab in combination with cetrelimab in Cohorts A and B at the RP2CD determined by the SET in Phase 1. Participants will continue study treatment until disease progression, unacceptable toxicity, or until another criterion for discontinuation of study treatment is met.

Group II: Phase 1 (Combination Dose Selection)Experimental Treatment2 Interventions

Participants will receive amivantamab low dose or high dose intravenous (IV) infusion based on body weight from Cycle 1 Day 1, Day 2, and subsequently Day 8, Day 15, and Day 22 and then every 2 weeks from Cycle 2 in combination with cetrelimab IV infusion from Cycle 1 Day 2 (after the Day 2 infusion of amivantamab). Doses will be escalated or de-escalated based on the dose limiting toxicities (DLTs) and the recommended Phase 2 combination dose (RP2CD) will be determined by the study evaluation team (SET).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetrelimab

2022

Completed Phase 1

~20

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies and immunotherapies. Targeted therapies like Amivantamab work by inhibiting specific proteins such as EGFR and MET, which are involved in the growth and survival of cancer cells. Immunotherapies like Cetrelimab target immune checkpoints such as PD-1, enhancing the body's immune response against cancer cells. These treatments are significant for NSCLC patients as they offer personalized therapy options that can be more effective and have fewer side effects compared to traditional chemotherapy, especially for tumors with specific genetic mutations.

Non-small Cell Lung Cancer with EGFR or HER2 Exon 20 Insertion Mutations: Diagnosis and Treatment Options.MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small-cell lung cancer.Predictive biomarkers for response to EGFR-directed monoclonal antibodies for advanced squamous cell lung cancer.