The Absolute Effect / Oncology Evidence / Evidence Index

Non-Small Cell Lung Cancer · Medical · Advanced / Metastatic · First-line EGFR exon20 insertion-mutated advanced NSCLC

PAPILLON

In untreated advanced NSCLC with EGFR exon 20 insertion, does amivantamab plus carboplatin-pemetrexed improve progression-free survival over chemotherapy?

Registry: NCT04538664 · Evidence reviewed 9 November 2026 · Aliases and follow-up publications consolidated.

Phase III randomized open-label; n=308.Primary-source evidence summary

Study design, population and eligibility

Design and sample

Phase III randomized open-label; n=308.

Population

Untreated advanced NSCLC with EGFR exon20 insertion.

Treatment and comparator

Intervention: Amivantamab + carboplatin/pemetrexed.

Comparator: Carboplatin/pemetrexed; crossover allowed.

Endpoints

PFS by BICR primary.

Key efficacy and clinical outcomes

Median PFS 11.4 vs 6.7 mo (HR 0.40); ORR 73% vs 47%; interim OS HR 0.67 (0.42–1.09).

Source-reported outcome visualization

Values are reproduced from the cited report; bars are scaled within this figure. First-line EGFR exon20 insertion-mutated advanced NSCLC

Median PFS amivantamab+chemo
11.4%
Median PFS chemo
6.7%

Median survival and hazard ratios are not fixed-time event risks; NNT is not inferred from them.

Toxicity and treatment burden

Infusion reactions, rash, paronychia and EGFR toxicity plus platinum-pemetrexed effects.

Absolute effect and NNT/NNH

Molecularly specific exon20 population; OS immature at primary report.

NNT/NNH is not calculated unless a directly reported, comparable fixed-time risk difference supports it. Median survival and hazard ratios alone do not provide an NNT.

Critical interpretation and limitations

Molecularly specific exon20 population; OS immature at primary report.

This page is an evidence summary, not a substitute for multidisciplinary assessment or patient-specific decision-making.

Current-practice context

Review date: 9 November 2026. Primary publication and selected follow-up sources were reviewed. Full disease-specific guideline, regulatory-label and sequencing audit remains pending; verify current local recommendations and biomarker eligibility before clinical application.

Primary publication and authoritative source

https://www.nejm.org/doi/10.1056/NEJMoa2306441

ClinicalTrials.gov NCT04538664