EGFR Exon 20 Insertion

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Molecular profile	Therapy	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
Lung Adenocarcinoma5
EGFR Exon 20 Insertion	Afatinib	Predictive	B	Supports Resistance	3	accepted	EID1809 In retrospective analysis of trials, afatinib conferred limited clinical benefit to patients with EGFR exon 20 insertion mutations (N=23). Only 2 patients had objective responses. PMID 26051236 · Yang et al., 2015 · Open in CIViC	civic
EGFR Exon 20 Insertion	Erlotinib	Predictive	B	Supports Resistance	2	submitted	EID9222 A retrospective study showed that out of 11 patients with stage IV lung adenocarcinoma treated with erlotinib who carried in-frame exon 20 insertion variant, only 3 patients showed objective response … (full text at CIViC) PMID 26096453 · Naidoo et al., 2015 · Open in CIViC	civic
EGFR Exon 20 Insertion

Molecular profile

Therapy

Type

Level

Direction · significance

Rating (1–5)

Status

Evidence

Source

Lung Adenocarcinoma5

EGFR Exon 20 Insertion

Afatinib

Predictive

Supports Resistance

accepted

EID1809

In retrospective analysis of trials, afatinib conferred limited clinical benefit to patients with EGFR exon 20 insertion mutations (N=23). Only 2 patients had objective responses.

PMID 26051236 · Yang et al., 2015 · Open in CIViC

civic

EGFR Exon 20 Insertion

Erlotinib

Predictive

Supports Resistance

submitted

EID9222

A retrospective study showed that out of 11 patients with stage IV lung adenocarcinoma treated with erlotinib who carried in-frame exon 20 insertion variant, only 3 patients showed objective response … (full text at CIViC)

PMID 26096453 · Naidoo et al., 2015 · Open in CIViC

civic

EGFR Exon 20 Insertion

Lung Non-Small Cell Carcinoma6
EGFR Exon 20 Insertion	Amivantamab	Predictive	A	Supports Sensitivity Response	4	accepted	EID11227 In this phase 1, open-label, dose-escalation trial, 81 patients with NSCLC involving an EGFR exon 20 insertion in phase 2 of the study were administered 1,050 mg amivantamab (1,400 mg if > 80 kg) give… (full text at CIViC) PMID 34339292 · Park et al., 2021 · Open in CIViC	civic
EGFR Exon 20 Insertion	Amivantamab + ChemotherapyCombination	Predictive	A	Supports Sensitivity Response	4	accepted	EID12014 In this phase 3 trial, 308 patients with NSCLC harbouring EGFR exon 20 insertions were treated with a combination of amivantamab and chemotherapy (carboplatin-pemetrexed) [n = 153] or chemotherapy alo… (full text at CIViC) PMID 37870976 · Zhou et al., 2023 · Open in CIViC	civic
EGFR Exon 20 Insertion	Mobocertinib	Predictive	A	Supports Sensitivity Response	4	accepted	EID11228 In this open-label phase1/2 trial, 114 patients with EGFR exon 20 insertion NSCLC who were previously treated with platinum received 160 mg mobocertinib once daily. The primary endpoint was confirmed … (full text at CIViC) PMID 34647988 · Zhou et al., 2021 · Open in CIViC	civic
EGFR Exon 20 Insertion	Osimertinib	Predictive	B	Supports Sensitivity Response	2	accepted	EID7610 Retrospective study of six Chinese patients with EGFR exon 20 insertion mutant stage IV non-small cell lung carcinoma treated with osimertinib. Four of the patients experienced partial response (67.7%… (full text at CIViC) PMID 31208370 · Fang et al., 2019 · Open in CIViC	civic
EGFR Exon 20 Insertion	Sunvozertinib	Predictive	A	Supports Sensitivity Response	4	accepted	EID12718 In a multinational open label phase II dose randomized study of sunvozertinib in platinum pretreated advanced NSCLC with EGFR exon 20 insertion mutations (WU-KONG1B, NCT03974022; efficacy n = 85 for 2… (full text at CIViC) PMID 40923280 · Yang et al., 2025 · Open in CIViC	civic
EGFR Exon 20 Insertion	TAK-788	Predictive	B	Supports Sensitivity Response	2	submitted	EID7273 This is a phase I/II study patients with NSCLC received TAK-288. In patients with EGFR exon 20 insertions, 24 patients who received 80 - 160 mg total daily dose showed ORR of 39% and DCR of 94%. Open in CIViC	civic

Lung Non-Small Cell Carcinoma6

EGFR Exon 20 Insertion

Amivantamab

Predictive

Supports Sensitivity Response

accepted

EID11227

In this phase 1, open-label, dose-escalation trial, 81 patients with NSCLC involving an EGFR exon 20 insertion in phase 2 of the study were administered 1,050 mg amivantamab (1,400 mg if > 80 kg) give… (full text at CIViC)

PMID 34339292 · Park et al., 2021 · Open in CIViC

civic

EGFR Exon 20 Insertion

Amivantamab + ChemotherapyCombination

Predictive

Supports Sensitivity Response

accepted

EID12014

In this phase 3 trial, 308 patients with NSCLC harbouring EGFR exon 20 insertions were treated with a combination of amivantamab and chemotherapy (carboplatin-pemetrexed) [n = 153] or chemotherapy alo… (full text at CIViC)

PMID 37870976 · Zhou et al., 2023 · Open in CIViC

civic

EGFR Exon 20 Insertion

Mobocertinib

Predictive

Supports Sensitivity Response

accepted

EID11228

In this open-label phase1/2 trial, 114 patients with EGFR exon 20 insertion NSCLC who were previously treated with platinum received 160 mg mobocertinib once daily. The primary endpoint was confirmed … (full text at CIViC)

PMID 34647988 · Zhou et al., 2021 · Open in CIViC

civic

EGFR Exon 20 Insertion

Osimertinib

Predictive

Supports Sensitivity Response

accepted

EID7610

Retrospective study of six Chinese patients with EGFR exon 20 insertion mutant stage IV non-small cell lung carcinoma treated with osimertinib. Four of the patients experienced partial response (67.7%… (full text at CIViC)

PMID 31208370 · Fang et al., 2019 · Open in CIViC

civic

EGFR Exon 20 Insertion

Sunvozertinib

Predictive

Supports Sensitivity Response

accepted

EID12718

In a multinational open label phase II dose randomized study of sunvozertinib in platinum pretreated advanced NSCLC with EGFR exon 20 insertion mutations (WU-KONG1B, NCT03974022; efficacy n = 85 for 2… (full text at CIViC)

PMID 40923280 · Yang et al., 2025 · Open in CIViC

civic

EGFR Exon 20 Insertion

TAK-788

Predictive

Supports Sensitivity Response

submitted

EID7273

This is a phase I/II study patients with NSCLC received TAK-288. In patients with EGFR exon 20 insertions, 24 patients who received 80 - 160 mg total daily dose showed ORR of 39% and DCR of 94%.

Open in CIViC

civic

Evidence by cancer (11 items)

Clinical significance (0)