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HEALTH PROFESSIONAL · SOURCE READING

Amivantamab

Source: Non-Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.

Source updated: May 15, 2025 · Captured 2026-09-09.

Selected source text with whitespace normalised. This Triangle page is not an NCI PDQ summary.

Context: Treatment of Newly Diagnosed Stage IV, Relapsed, and Recurrent NSCLC / Treatment Options for Newly Diagnosed Stage IV, Relapsed, and Recurrent NSCLC (First-Line Therapy) / EGFR-directed therapy (for patients with EGFR exon 20 insertions)

Amivantamab has been previously approved for patients with locally advanced or metastatic NSCLC and EGFR exon 20 insertions whose disease has progressed during or after platinum-based chemotherapy.

Evidence (amivantamab plus chemotherapy):

PAPILLON (NCT04538664) was a phase III randomized trial that compared amivantamab plus chemotherapy with chemotherapy alone as first-line treatment for patients with advanced NSCLC and EGFR exon 20 insertions. Patients in the chemotherapy-alone group who had disease progression were allowed to cross over to receive amivantamab monotherapy. A total of 308 patients were randomly assigned 1:1 to receive either amivantamab plus carboplatin and pemetrexed or carboplatin plus pemetrexed. The primary end point was PFS according to blinded independent central review. The median follow-up was 14.9 months.[63][Level of evidence B1] The study supports amivantamab plus chemotherapy as an effective first-line treatment option for patients with NSCLC and EGFR exon 20 insertions based on superior PFS when compared with chemotherapy alone.[63]

Source links and citations

PAPILLON (NCT04538664) was a phase III randomized trial that compared amivantamab plus chemotherapy with chemotherapy alone as first-line treatment for patients with advanced NSCLC and EGFR exon 20 insertions. Patients in the chemotherapy-alone group who had disease progression were allowed to cross over to receive amivantamab monotherapy. A total of 308 patients were randomly assigned 1:1 to receive either amivantamab plus carboplatin and pemetrexed or carboplatin plus pemetrexed. The primary end point was PFS according to blinded independent central review. The median follow-up was 14.9 months.[63][Level of evidence B1] The study supports amivantamab plus chemotherapy as an effective first-line treatment option for patients with NSCLC and EGFR exon 20 insertions based on superior PFS when compared with chemotherapy alone.[63]

At 18 months, the PFS rate was 31% for patients who received amivantamab plus chemotherapy, and 3% for patients who received chemotherapy alone.

PAPILLON (NCT04538664) was a phase III randomized trial that compared amivantamab plus chemotherapy with chemotherapy alone as first-line treatment for patients with advanced NSCLC and EGFR exon 20 insertions. Patients in the chemotherapy-alone group who had disease progression were allowed to cross over to receive amivantamab monotherapy. A total of 308 patients were randomly assigned 1:1 to receive either amivantamab plus carboplatin and pemetrexed or carboplatin plus pemetrexed. The primary end point was PFS according to blinded independent central review. The median follow-up was 14.9 months.[63][Level of evidence B1] The study supports amivantamab plus chemotherapy as an effective first-line treatment option for patients with NSCLC and EGFR exon 20 insertions based on superior PFS when compared with chemotherapy alone.[63]

The objective response rate was higher in the amivantamab-plus-chemotherapy group (73%) than the chemotherapy-alone group (47%).

PAPILLON (NCT04538664) was a phase III randomized trial that compared amivantamab plus chemotherapy with chemotherapy alone as first-line treatment for patients with advanced NSCLC and EGFR exon 20 insertions. Patients in the chemotherapy-alone group who had disease progression were allowed to cross over to receive amivantamab monotherapy. A total of 308 patients were randomly assigned 1:1 to receive either amivantamab plus carboplatin and pemetrexed or carboplatin plus pemetrexed. The primary end point was PFS according to blinded independent central review. The median follow-up was 14.9 months.[63][Level of evidence B1] The study supports amivantamab plus chemotherapy as an effective first-line treatment option for patients with NSCLC and EGFR exon 20 insertions based on superior PFS when compared with chemotherapy alone.[63]

In an interim OS analysis, there was no statistically significant difference.

PAPILLON (NCT04538664) was a phase III randomized trial that compared amivantamab plus chemotherapy with chemotherapy alone as first-line treatment for patients with advanced NSCLC and EGFR exon 20 insertions. Patients in the chemotherapy-alone group who had disease progression were allowed to cross over to receive amivantamab monotherapy. A total of 308 patients were randomly assigned 1:1 to receive either amivantamab plus carboplatin and pemetrexed or carboplatin plus pemetrexed. The primary end point was PFS according to blinded independent central review. The median follow-up was 14.9 months.[63][Level of evidence B1] The study supports amivantamab plus chemotherapy as an effective first-line treatment option for patients with NSCLC and EGFR exon 20 insertions based on superior PFS when compared with chemotherapy alone.[63]

The most common adverse events with amivantamab plus chemotherapy were hematologic toxicities, rash, and paronychia. Infusion reactions occurred in 42% of patients.

Studies cited in this source section

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Publication references

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Preserved source evidence · Not medical advice