Trial Outcomes & Findings for Bintrafusp Alfa With Chemotherapy for Tyrosine Kinase Inhibitor-Resistant EGFR-Mutant Non-small Cell Lung Cancer (NCT NCT04971187)
NCT ID: NCT04971187
Last Updated: 2023-08-01
Results Overview
Objective response was assessed by RECIST 1.1. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
TERMINATED
PHASE2
3 participants
Within 6 months since initiation of treatment
2023-08-01
Participant Flow
3 participants were registered, 2 participants were not treated, not eligible or inevaluable, 1 participants received treatment
Participant milestones
| Measure |
Treatment (Bintrafusp Alfa, Pemetrexed, Carboplatin/Cisplatin)
Patients receive bintrafusp alfa IV over 1 hour on day 1 and pemetrexed IV over 10 minutes on day 1. Patients also receive carboplatin IV over 15 minutes or cisplatin IV over 6-8 hours at the physician's discretion on day 1 of cycles 1-4. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Overall Study
STARTED
|
3
|
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Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Bintrafusp Alfa, Pemetrexed, Carboplatin/Cisplatin)
Patients receive bintrafusp alfa IV over 1 hour on day 1 and pemetrexed IV over 10 minutes on day 1. Patients also receive carboplatin IV over 15 minutes or cisplatin IV over 6-8 hours at the physician's discretion on day 1 of cycles 1-4. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Overall Study
Screen failures
|
2
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Baseline Characteristics
Bintrafusp Alfa With Chemotherapy for Tyrosine Kinase Inhibitor-Resistant EGFR-Mutant Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Bintrafusp Alfa, Pemetrexed, Carboplatin/Cisplatin)
n=3 Participants
Patients receive bintrafusp alfa IV over 1 hour on day 1 and pemetrexed IV over 10 minutes on day 1. Patients also receive carboplatin IV over 15 minutes or cisplatin IV over 6-8 hours at the physician's discretion on day 1 of cycles 1-4. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
3 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
|
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Region of Enrollment
United States
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3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 6 months since initiation of treatmentPopulation: No data was collected
Objective response was assessed by RECIST 1.1. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 18 weeksPopulation: No data was collected
PFS is defined as the date of randomization to the date of disease progression or death due to any cause, whichever occurs earlier as per Response evaluation criteria in solid tumors (RECIST) version 1.1 at 18 weeks.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days post-treatmentPopulation: No data was collected
Safety and tolerability as measured by all adverse events (AEs). Safety and tolerability will be described using frequency of AEs and AEs of Common Terminology Criteria for Adverse Events (CTCAE 5.0). Safety analyses will include all patients who have received at least one dose of study drug and will be evaluated descriptively.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: No data was collected
PFS is defined as the date of randomization to the date of disease progression or death due to any cause, whichever occurs earlier as per Response evaluation criteria in solid tumors (RECIST) version 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: No data was collected
DCR was defined as the proportion of patients who had an overall response of complete response (CR), partial response (PR), or stable disease (SD). According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: No data was collected
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause. Participants without events reported are censored at the last disease evaluation)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: No data was collected
Overall Survival (OS) is defined as the time from treatment to death due to any cause, or censored at date last known alive.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Bintrafusp Alfa, Pemetrexed, Carboplatin/Cisplatin)
Serious adverse events
| Measure |
Treatment (Bintrafusp Alfa, Pemetrexed, Carboplatin/Cisplatin)
n=1 participants at risk
Patients receive bintrafusp alfa IV over 1 hour on day 1 and pemetrexed IV over 10 minutes on day 1. Patients also receive carboplatin IV over 15 minutes or cisplatin IV over 6-8 hours at the physician's discretion on day 1 of cycles 1-4. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 4 • From the first dose through 30 days after the last dose of study medication, up to 3 months.
Serious adverse events will be captured from the time of the first protocol-specific intervention, until 90 days after the last dose of drug, unless the participant withdraws consent.
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|
Musculoskeletal and connective tissue disorders
Arthritis
|
100.0%
1/1 • Number of events 1 • From the first dose through 30 days after the last dose of study medication, up to 3 months.
Serious adverse events will be captured from the time of the first protocol-specific intervention, until 90 days after the last dose of drug, unless the participant withdraws consent.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
100.0%
1/1 • Number of events 1 • From the first dose through 30 days after the last dose of study medication, up to 3 months.
Serious adverse events will be captured from the time of the first protocol-specific intervention, until 90 days after the last dose of drug, unless the participant withdraws consent.
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|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Number of events 1 • From the first dose through 30 days after the last dose of study medication, up to 3 months.
Serious adverse events will be captured from the time of the first protocol-specific intervention, until 90 days after the last dose of drug, unless the participant withdraws consent.
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|
Nervous system disorders
Dysgeusia
|
100.0%
1/1 • Number of events 1 • From the first dose through 30 days after the last dose of study medication, up to 3 months.
Serious adverse events will be captured from the time of the first protocol-specific intervention, until 90 days after the last dose of drug, unless the participant withdraws consent.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • From the first dose through 30 days after the last dose of study medication, up to 3 months.
Serious adverse events will be captured from the time of the first protocol-specific intervention, until 90 days after the last dose of drug, unless the participant withdraws consent.
|
|
Infections and infestations
Nail Infection
|
100.0%
1/1 • Number of events 1 • From the first dose through 30 days after the last dose of study medication, up to 3 months.
Serious adverse events will be captured from the time of the first protocol-specific intervention, until 90 days after the last dose of drug, unless the participant withdraws consent.
|
|
Ear and labyrinth disorders
Tinnitus
|
100.0%
1/1 • Number of events 1 • From the first dose through 30 days after the last dose of study medication, up to 3 months.
Serious adverse events will be captured from the time of the first protocol-specific intervention, until 90 days after the last dose of drug, unless the participant withdraws consent.
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place