NCT03414814

Osimertinib for NSCLC With EGFR Exon 20 Insertion Mutation

Completed Phase 2 Results posted Last updated 11 February 2025

What this trial tests

Phase 2 trial testing Osimertinib 80 MG [Tagrisso] in Locally Advanced or Metastatic NSCLC in 15 participants. Completed in 3 August 2021.

Timeline

4 January 2018

Primary endpoint
3 August 2021

3 August 2021

Quick facts

Lead sponsor	Seoul National University Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	4 January 2018
Primary completion	3 August 2021
Estimated completion	3 August 2021
Sites	1 location across South Korea

Drugs / interventions tested

• Osimertinib 80 MG [Tagrisso] — full drug profile →

Conditions studied

• Locally Advanced or Metastatic NSCLC — all drugs for Locally Advanced or Metastatic NSCLC →

Sponsor

Seoul National University Hospital

Who can join

19 and older, any sex, with Locally Advanced or Metastatic NSCLC. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Objective Response Rate Primary · Until study completion, from date of initiation until the date of first documented progression, unacceptable toxicities or withdrawl, whichever came first. (upto about 29months)

Investigator-assessed, confirmed objective response by RECIST version 1.1

Group	Value	95% CI
Osimertinib	0

Serious Adverse Events Secondary · From date of initiation until the date of first documented progression, unacceptable toxicities or withdrawal, whichever came first. Until study completion. (upto about 29months)

AEs/SAEs as defined by NCI CTCAE version 4.0

General weakness

Group	Value	95% CI
Osimertinib	1

Acute urinary retention

Group	Value	95% CI
Osimertinib	1

Pneumonia

Group	Value	95% CI
Osimertinib	2

Colitis

Group	Value	95% CI
Osimertinib	1

Azotemia

Group	Value	95% CI
Osimertinib	1

Hypercalcemia

Group	Value	95% CI
Osimertinib	1

Femur fracture

Group	Value	95% CI
Osimertinib	1

Progression-free Survival Secondary · From date of initiation until the date of first documented progression, unacceptable toxicities or withdrawl, whichever came first. Until study completion. (upto about 29months)

PFS as defined by RECIST version 1.1

Group	Value	95% CI
Osimertinib	3.8	1.7 – 5.5

Overall Survival Secondary · From the first date of IP administration to the date of death. (upto about 29months)

OS as defined by RECIST version 1.1. The time from the first date of IP administration to the date of death.

Group	Value	95% CI
Osimertinib	6.5	3.9 – 29

Adverse events — posted to ClinicalTrials.gov

Time frame: from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Osimertinib

Serious: 8/15 (53%)

Deaths: 2/15

Serious adverse events (7 terms)

Reaction	System	Osimertinib
Pneumonia	Respiratory, thoracic and mediastinal disorders	—
Colitis	Gastrointestinal disorders	—
Azotemia	Renal and urinary disorders	—
Hyperglycemia	Blood and lymphatic system disorders	—
General weakness	General disorders	—
Acute urinary retention	Renal and urinary disorders	—
Femur fracture	Musculoskeletal and connective tissue disorders	—

Other adverse events (19 terms — click to expand)

Reaction	System	Osimertinib
Anaemia	Blood and lymphatic system disorders	—
Dyspepsia	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Pyrexia	General disorders	—
Diarrhoea	Gastrointestinal disorders	—
Dry eye	Eye disorders	—
Thrombocytopenia	Blood and lymphatic system disorders	—
Colitis	Gastrointestinal disorders	—
Constipation	Gastrointestinal disorders	—
Dysphagia	Gastrointestinal disorders	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—
Asthenia	General disorders	—
Face oedema	General disorders	—
Gait disturbance	General disorders	—
Localised oedema	General disorders	—
Non-cardiac chest pain	General disorders	—
Oedema peripheral	General disorders	—
Pain	General disorders	—

Most-reported serious reactions: Pneumonia, Colitis, Azotemia, Hyperglycemia, General weakness, Acute urinary retention, Femur fracture.

Data from ClinicalTrials.gov NCT03414814 adverse events section.

Sponsor's own description

This is a single-arm, non-randomized multicentre phase 2 study in NSCLC patients with EGFR exon 20 insertion mutation, whose disease has progressed on standard chemotherapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Rare epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer.
   Harrison PT, Vyse S, Huang PH. · · 2020 · cited 434× · PMID 31562956 · DOI 10.1016/j.semcancer.2019.09.015
2. Targeting <i>EGFR</i> exon 20 insertion mutations in non-small cell lung cancer.
   Vyse S, Huang PH. · · 2019 · cited 262× · PMID 30854234 · DOI 10.1038/s41392-019-0038-9
3. Mechanisms and management of 3rd‑generation EGFR‑TKI resistance in advanced non‑small cell lung cancer (Review).
   He J, Huang Z, Han L, Gong Y, et al · · 2021 · cited 232× · PMID 34558640 · DOI 10.3892/ijo.2021.5270
4. Heterogeneous Responses to Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitors (TKIs) in Patients with Uncommon EGFR Mutations: New Insights and Future Perspectives in this Complex Clinical Scenario.
   Russo A, Franchina T, Ricciardi G, Battaglia A, et al · · 2019 · cited 91× · PMID 30901844 · DOI 10.3390/ijms20061431
5. Targeting <i>EGFR</i> Exon 20 Insertions in Non-Small Cell Lung Cancer: Recent Advances and Clinical Updates.
   Meador CB, Sequist LV, Piotrowska Z. · · 2021 · cited 77× · PMID 34301786 · DOI 10.1158/2159-8290.cd-21-0226
6. Epidemiological and clinical burden of EGFR Exon 20 insertion in advanced non-small cell lung cancer: A systematic literature review.
   Burnett H, Emich H, Carroll C, Stapleton N, et al · · 2021 · cited 76× · PMID 33684140 · DOI 10.1371/journal.pone.0247620
7. Variability of EGFR exon 20 insertions in 24 468 Chinese lung cancer patients and their divergent responses to EGFR inhibitors.
   Qin Y, Jian H, Tong X, Wu X, et al · · 2020 · cited 47× · PMID 32412152 · DOI 10.1002/1878-0261.12710
8. Predictive and Prognostic Biomarkers for Lung Cancer Bone Metastasis and Their Therapeutic Value.
   Chai X, Yinwang E, Wang Z, Wang Z, et al · · 2021 · cited 36× · PMID 34722241 · DOI 10.3389/fonc.2021.692788