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Monoclonal Antibodies

Amivantamab + Chemotherapy for Non-Small Cell Lung Cancer (PAPILLON Trial)

Phase 3

Waitlist Available

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

A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study

Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation

Must not have

Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation

Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to either disease progression or death whichever occurs first (up to 29 months)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare how effective amivantamab is at treating NSCLC with EGFR Exon 20ins mutations, compared to chemotherapy alone. The metric for success is progression-free survival (PFS).

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has a specific mutation called EGFR Exon 20 insertion. They must have measurable disease, be in good physical condition (ECOG status 0 or 1), and agree to genetic tests of their tumor. Women who can have children must test negative for pregnancy.

What is being tested?

The study is testing the effectiveness of Amivantamab combined with Carboplatin-Pemetrexed chemotherapy versus just the chemotherapy alone. The main goal is to see which treatment stops the cancer from progressing longer.

What are the potential side effects?

Possible side effects include reactions at the infusion site, fatigue, nausea, low blood counts increasing infection risk, potential lung problems like pneumonitis or ILD, and allergic reactions to components of the therapy.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman who can have children, have tested negative for pregnancy, and agree to ongoing pregnancy tests.

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My lung cancer is advanced, not squamous, and has a specific EGFR mutation.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I have untreated spinal cord compression.

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I have a history of lung conditions like ILD or radiation pneumonitis.

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I cannot take carboplatin or pemetrexed due to health reasons.

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My lung cancer diagnosis was confirmed by genetic tests or scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to either disease progression or death whichever occurs first (up to 29 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to either disease progression or death whichever occurs first (up to 29 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to either disease progression or death whichever occurs first (up to 29 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) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B: Chemotherapy AloneExperimental Treatment2 Interventions

Participants will receive pemetrexed 500 mg/m\^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin for up to 4 cycles, and then as maintenance monotherapy until disease progression. Carboplatin AUC 5 IV infusion will be administered on Day 1 of each 21-day cycle for up to 4 cycles. Following the primary analysis for efficacy, the study will transition to an OLE phase and participants will either continue to receive the chemotherapy or cross over to amivantamab in OLE phase. Participants who completed OLE period will enter LTE period and continue to receive same treatment.

Group II: Arm A: Amivantamab + ChemotherapyExperimental Treatment3 Interventions

Participants will receive pemetrexed 500 milligram per meter square (mg/m\^2) intravenous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin for up to 4 cycles, and then as maintenance monotherapy until disease progression. Carboplatin area under the concentration-time curve 5 milligram per milliliter (mg/mL) per minute (AUC 5) will be administered as IV infusion on Day 1 of each 21 day cycle, for up to 4 cycles. Participants will receive amivantamab 1400 mg (1750 mg if body weight is \>=80 kilogram \[kg\]) by IV infusion once weekly up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is \>=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3. Following the primary analysis for efficacy, the study will transition to an OLE phase and participants will continue to receive the amivantamab plus chemotherapy in OLE phase. Participants who completed OLE period will enter LTE period and continue to receive same treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Pemetrexed

2014

Completed Phase 3

~5550