Trial Outcomes & Findings for Osimertinib for NSCLC With EGFR Exon 20 Insertion Mutation (NCT NCT03414814)
NCT ID: NCT03414814
Last Updated: 2025-02-11
Results Overview
Investigator-assessed, confirmed objective response by RECIST version 1.1
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Until study completion, from date of initiation until the date of first documented progression, unacceptable toxicities or withdrawl, whichever came first. (upto about 29months)
Results posted on
2025-02-11
Participant Flow
Participant milestones
| Measure |
Osimertinib
Osimertinib at 80mg dose will be administered orally once daily.
Osimertinib 80 MG \[Tagrisso\]: Osimertinib 80mg once daily until disease progression
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Osimertinib for NSCLC With EGFR Exon 20 Insertion Mutation
Baseline characteristics by cohort
| Measure |
Osimertinib
n=15 Participants
Osimertinib at 80mg dose will be administered orally once daily.
Osimertinib 80 MG \[Tagrisso\]: Osimertinib 80mg once daily until disease progression
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Until study completion, from date of initiation until the date of first documented progression, unacceptable toxicities or withdrawl, whichever came first. (upto about 29months)Population: The proportion of patients who had complete reponse (CR) and partial reponse (PR) as the best response among 80mg osimertinib administered 15 patients.
Investigator-assessed, confirmed objective response by RECIST version 1.1
Outcome measures
| Measure |
Osimertinib
n=15 Participants
Osimertinib at 80mg dose will be administered orally once daily.
Osimertinib 80 MG \[Tagrisso\]: Osimertinib 80mg once daily until disease progression
|
|---|---|
|
Objective Response Rate
|
0 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Osimertinib
n=15 Participants
Osimertinib at 80mg dose will be administered orally once daily.
Osimertinib 80 MG \[Tagrisso\]: Osimertinib 80mg once daily until disease progression
|
|---|---|
|
Serious Adverse Events
Azotemia
|
1 cases
|
|
Serious Adverse Events
General weakness
|
1 cases
|
|
Serious Adverse Events
Acute urinary retention
|
1 cases
|
|
Serious Adverse Events
Pneumonia
|
2 cases
|
|
Serious Adverse Events
Colitis
|
1 cases
|
|
Serious Adverse Events
Hypercalcemia
|
1 cases
|
|
Serious Adverse Events
Femur fracture
|
1 cases
|
SECONDARY outcome
Timeframe: From date of initiation until the date of first documented progression, unacceptable toxicities or withdrawl, whichever came first. Until study completion. (upto about 29months)Population: The PFS rate at the time of data cutoff (10 June 2020) for 80mg osimertinib administered 15 patients
PFS as defined by RECIST version 1.1
Outcome measures
| Measure |
Osimertinib
n=15 Participants
Osimertinib at 80mg dose will be administered orally once daily.
Osimertinib 80 MG \[Tagrisso\]: Osimertinib 80mg once daily until disease progression
|
|---|---|
|
Progression-free Survival
|
3.8 months
Interval 1.7 to 5.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Osimertinib
n=15 Participants
Osimertinib at 80mg dose will be administered orally once daily.
Osimertinib 80 MG \[Tagrisso\]: Osimertinib 80mg once daily until disease progression
|
|---|---|
|
Overall Survival
|
6.5 months
Interval 3.9 to 29.0
|
Adverse Events
Osimertinib
Serious events: 8 serious events
Other events: 15 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Osimertinib
n=15 participants at risk
Osimertinib at 80mg dose will be administered orally once daily.
Osimertinib 80 MG \[Tagrisso\]: Osimertinib 80mg once daily until disease progression
|
|---|---|
|
Gastrointestinal disorders
Colitis
|
6.7%
1/15 • Number of events 1 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
Renal and urinary disorders
Azotemia
|
6.7%
1/15 • Number of events 1 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
6.7%
1/15 • Number of events 1 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
General disorders
General weakness
|
6.7%
1/15 • Number of events 1 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
Renal and urinary disorders
Acute urinary retention
|
6.7%
1/15 • Number of events 1 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
13.3%
2/15 • Number of events 2 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
Musculoskeletal and connective tissue disorders
Femur fracture
|
6.7%
1/15 • Number of events 1 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
Other adverse events
| Measure |
Osimertinib
n=15 participants at risk
Osimertinib at 80mg dose will be administered orally once daily.
Osimertinib 80 MG \[Tagrisso\]: Osimertinib 80mg once daily until disease progression
|
|---|---|
|
Eye disorders
Dry eye
|
6.7%
1/15 • Number of events 1 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
Blood and lymphatic system disorders
Anaemia
|
26.7%
4/15 • Number of events 4 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
1/15 • Number of events 1 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
Gastrointestinal disorders
Colitis
|
6.7%
1/15 • Number of events 1 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
2/15 • Number of events 2 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
3/15 • Number of events 3 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
1/15 • Number of events 1 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.7%
1/15 • Number of events 1 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
Gastrointestinal disorders
Nausea
|
20.0%
3/15 • Number of events 3 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
3/15 • Number of events 3 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
General disorders
Asthenia
|
6.7%
1/15 • Number of events 1 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
General disorders
Face oedema
|
6.7%
1/15 • Number of events 1 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
General disorders
Gait disturbance
|
6.7%
1/15 • Number of events 1 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
General disorders
Localised oedema
|
6.7%
1/15 • Number of events 1 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
General disorders
Non-cardiac chest pain
|
6.7%
1/15 • Number of events 1 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
General disorders
Oedema peripheral
|
6.7%
1/15 • Number of events 1 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
General disorders
Pain
|
6.7%
1/15 • Number of events 1 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
|
General disorders
Pyrexia
|
20.0%
3/15 • Number of events 3 • from the day of first IP administration to 30 days after the last IP administration (till PD or unacceptable toxicity), (upto about 29months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place