Trial Outcomes & Findings for Osimertinib Plus Chemotherapy in Uncommon EGFRm NSCLC (NCT NCT05215951)
NCT ID: NCT05215951
Last Updated: 2025-10-15
Results Overview
ORR (objective response rate) defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) as their best overall response based on Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the investigator
TERMINATED
PHASE2
4 participants
Due to study early terminated, actual time frame is up to 24 weeks.
2025-10-15
Participant Flow
4 subjects enrolled in the study in total.
Participant milestones
| Measure |
Osimertinib Plus Standard Chemotherapy
Dose Formulation: tablet； Dosage Level(s): osimertinib 80 mg QD for oral administration; Dosage formulation, dose reduction:40 mg QD for oral administration
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Osimertinib Plus Chemotherapy in Uncommon EGFRm NSCLC
Baseline characteristics by cohort
| Measure |
Osimertinib Plus Standard Chemotherapy Single-arm
n=4 Participants
Dose Formulation: tablet； Dosage Level(s): osimertinib 80 mg QD for oral administration; Dosage formulation, dose reduction:40 mg QD for oral administration
|
|---|---|
|
Age, Customized
18-130
|
4 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Female and male
|
4 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not collected
|
4 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Due to study early terminated, actual time frame is up to 24 weeks.Population: All enrolled participants who have received at least 1 dose of study intervention (osimertinib).
ORR (objective response rate) defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) as their best overall response based on Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the investigator
Outcome measures
| Measure |
Osimertinib Plus Standard Chemotherapy Single-arm
n=4 Participants
Dose Formulation: tablet； Dosage Level(s): osimertinib 80 mg QD for oral administration; Dosage formulation, dose reduction:40 mg QD for oral administration
|
|---|---|
|
ORR
|
75.0 Percentage of Patients
Interval 19.4 to 99.4
|
SECONDARY outcome
Timeframe: Due to study early terminated, actual time frame is up to approximately 12 months.Population: All enrolled participants who have received at least 1 dose of study intervention (osimertinib).
PFS (Progression-free survival) will be defined as the time from first dose of study intervention until progression per RECIST 1.1 as assessed by the investigator or death due to any cause prior to PD (progressive disease).
Outcome measures
| Measure |
Osimertinib Plus Standard Chemotherapy Single-arm
n=4 Participants
Dose Formulation: tablet； Dosage Level(s): osimertinib 80 mg QD for oral administration; Dosage formulation, dose reduction:40 mg QD for oral administration
|
|---|---|
|
PFS
|
NA Months
Interval 3.29 to
Median and upper confidence limit were not reached due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Due to study early terminated, actual time frame is up to approximately 13 months.Population: All enrolled participants who have received at least 1 dose of study intervention (osimertinib).
OS (Overall survival) is defined as the time from the first dose of treatment to the date of death, regardless of the actual cause of the subject's death. For participants who are still alive at the time of data analysis or who are lost to follow up, OS will be right-censored at the last recorded date that the participant is known to be alive prior to or at the data cut-off date for the analysis.
Outcome measures
| Measure |
Osimertinib Plus Standard Chemotherapy Single-arm
n=4 Participants
Dose Formulation: tablet； Dosage Level(s): osimertinib 80 mg QD for oral administration; Dosage formulation, dose reduction:40 mg QD for oral administration
|
|---|---|
|
OS
|
NA Months
Interval 3.94 to
Median and upper confidence limit were not reached due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Due to study early terminated, actual time frame is up to approximately 12 months.Population: All enrolled participants who have received at least 1 dose of study intervention (osimertinib) with response.
DoR (Duration of response) is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression. The end of response should coincide with the date of progression or death from any cause used for the PFS endpoint. The time of the initial response will be defined as the latest of the dates contributing toward the first visit response of PR or CR. If a participant does not progress following a response, then his/her duration of response will use the PFS censoring time as the end point for their DoR calculation.
Outcome measures
| Measure |
Osimertinib Plus Standard Chemotherapy Single-arm
n=3 Participants
Dose Formulation: tablet； Dosage Level(s): osimertinib 80 mg QD for oral administration; Dosage formulation, dose reduction:40 mg QD for oral administration
|
|---|---|
|
DoR
|
NA Months
Median, lower and upper confidence limit were not reached due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Due to study early terminated, actual time frame is up to approximately 12 months.Population: All enrolled participants who have received at least 1 dose of study intervention (osimertinib) with response.
Depth of response (ie, tumour shrinkage / change in tumour size) by Investigator is defined as the relative change in the sum of the longest diameters of RECIST target lesions at the nadir in the absence of NLs (new lesions) or progression of NTLs (non-target lesions) when compared to baseline. The best absolute change in target lesion tumour size from baseline will be summarized using descriptive statistics. The best change in tumour size will include all assessments prior to progression or start of subsequent anti-cancer therapy.
Outcome measures
| Measure |
Osimertinib Plus Standard Chemotherapy Single-arm
n=3 Participants
Dose Formulation: tablet； Dosage Level(s): osimertinib 80 mg QD for oral administration; Dosage formulation, dose reduction:40 mg QD for oral administration
|
|---|---|
|
Depth of Response (Best Absolute Change in Target Lesion Tumour Size From Baseline)
|
47.50 mm
Interval 5.16 to 61.6
|
SECONDARY outcome
Timeframe: Due to study early terminated, actual time frame is up to approximately 12 months.Population: All enrolled participants who have received at least 1 dose of study intervention (osimertinib).
DCR (disease control rate) is defined as the percentage of subjects who have a best overall response of CR or PR or SD (stable disease) by RECIST 1.1 as assessed by the Investigator. For participants with a best overall response of SD, a RECIST assessment of SD must have been observed at least 6 weeks following enrolment to be included in the numerator of the calculation for disease control rate. This is to enable sufficient follow-up to establish SD.
Outcome measures
| Measure |
Osimertinib Plus Standard Chemotherapy Single-arm
n=4 Participants
Dose Formulation: tablet； Dosage Level(s): osimertinib 80 mg QD for oral administration; Dosage formulation, dose reduction:40 mg QD for oral administration
|
|---|---|
|
DCR
|
100 Percentage of patients
Interval 39.8 to 100.0
|
SECONDARY outcome
Timeframe: Due to study early terminated, actual time frame is up to approximately 13 months.Population: All enrolled participants who have received at least 1 dose of study intervention (osimertinib).
Time to treatment failure (TTF) or death is defined as defined as the time from first dose of study intervention (osimertinib) to earlier of the date of last study intervention administration or death due to any cause. Any participant not known to have permanently discontinued study intervention and not known to have died at the time of the analysis will be censored at the last known time on which the participant was known to be alive. Kaplan-Meier method will be used to estimate the median TTF and its 95% confidence interval.
Outcome measures
| Measure |
Osimertinib Plus Standard Chemotherapy Single-arm
n=4 Participants
Dose Formulation: tablet； Dosage Level(s): osimertinib 80 mg QD for oral administration; Dosage formulation, dose reduction:40 mg QD for oral administration
|
|---|---|
|
TTF
|
NA Months
Interval 3.29 to
Median and upper confidence limit were not reached due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Due to study early terminated, actual time frame is up to approximately 13 months.Population: All enrolled participants who have received at least 1 dose of study intervention (osimertinib).
Time to first subsequent therapy (TFST) or death is defined as the time from first dose of study intervention to the earlier of the date of anti-cancer therapy (except cisplatin or carboplatin or pemetrexed) start date following study intervention discontinuation or death due to any cause. Any participant not known to have had a subsequent therapy or not known to have died at the time of the analysis will be censored at the last known time to have not received subsequent therapy. Kaplan-Meier method will be used to estimate the median TFST and its 95% confidence interval.
Outcome measures
| Measure |
Osimertinib Plus Standard Chemotherapy Single-arm
n=4 Participants
Dose Formulation: tablet； Dosage Level(s): osimertinib 80 mg QD for oral administration; Dosage formulation, dose reduction:40 mg QD for oral administration
|
|---|---|
|
TFST
|
NA Months
Interval 3.94 to
Median and upper confidence limit were not reached due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Due to study early terminated, actual time frame is up to approximately 12 months.Population: All enrolled participants who have received at least 1 dose of study intervention (osimertinib) with response.
Depth of response (ie, tumour shrinkage / change in tumour size) by Investigator is defined as the relative change in the sum of the longest diameters of RECIST target lesions at the nadir in the absence of NLs or progression of NTLs when compared to baseline. Best percentage change in target lesion tumour size from baseline will be summarized using descriptive statistics. The best change in tumour size will include all assessments prior to progression or start of subsequent anti-cancer therapy.
Outcome measures
| Measure |
Osimertinib Plus Standard Chemotherapy Single-arm
n=3 Participants
Dose Formulation: tablet； Dosage Level(s): osimertinib 80 mg QD for oral administration; Dosage formulation, dose reduction:40 mg QD for oral administration
|
|---|---|
|
Depth of Response (Best Percentage Change in Target Lesion Tumour Size From Baseline)
|
53.61 percentage change in tumour size
Interval 40.57 to 78.67
|
Adverse Events
Osimertinib Plus Standard Chemotherapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Osimertinib Plus Standard Chemotherapy
n=4 participants at risk
Dose Formulation: tablet； Dosage Level(s): osimertinib 80 mg QD for oral administration; Dosage formulation, dose reduction:40 mg QD for oral administration
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
50.0%
2/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Blood and lymphatic system disorders
Anaemia
|
75.0%
3/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Cardiac disorders
Arrhythmia
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
50.0%
2/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
General disorders
Asthenia
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Hepatobiliary disorders
Blood lactate dehydrogenase increased
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Infections and infestations
COVID-19
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
General disorders
Fatigue
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Hepatobiliary disorders
Gamma-glutamyltransferase increased
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Nervous system disorders
Head discomfort
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
General disorders
Malaise
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Metabolism and nutrition disorders
Malnutrition
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Gastrointestinal disorders
Mouth ulceration
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
50.0%
2/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
General disorders
Pain
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
50.0%
2/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Renal and urinary disorders
Proteinuria
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Psychiatric disorders
Sleep disorder
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
|
Blood and lymphatic system disorders
White blood cell count decreased
|
75.0%
3/4 • From time of signature of informed consent form until 28 days after last dose of study intervention or until the end of study, whichever occurs earlier, up to 13.7 months when study terminated.
The study was terminated, statistical analyses were not performed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place