Trial Outcomes & Findings for Carboplatin Plus Etoposide With or Without MPDL3280A in Untreated Extensive Stage Small Cell Lung Cancer (NCT NCT02748889)
NCT ID: NCT02748889
Last Updated: 2018-07-02
Results Overview
Disease progression will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and bone scans.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
1 participants
Primary outcome timeframe
From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years.
Results posted on
2018-07-02
Participant Flow
Participant milestones
| Measure |
Carboplatin Plus Etoposide
Carboplatin AUC 5 iv on day 1 every 21 days for 4 cycles Etoposide 100mg/m2 iv on days 1-3 every 21 days for 4 cycles
Carboplatin: Standard chemotherapy
Etoposide: Standard chemotherapy
|
Carboplatin, Etoposide and MPDL3280A
Carboplatin AUC 5 iv on day 1 every 21 days for 4 cycles Etoposide 100mg/m2 iv on days 1-3 every 21 days for 4 cycles MPDL3280A (Atezolizumab) 1200mg iv on day 1 every 21 days until progression
Carboplatin: Standard chemotherapy
Etoposide: Standard chemotherapy
MPDL3280A: Experimental biologic
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Carboplatin Plus Etoposide With or Without MPDL3280A in Untreated Extensive Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Carboplatin Plus Etoposide
Carboplatin AUC 5 iv on day 1 every 21 days for 4 cycles Etoposide 100mg/m2 iv on days 1-3 every 21 days for 4 cycles
Carboplatin: Standard chemotherapy
Etoposide: Standard chemotherapy
|
Carboplatin, Etoposide and MPDL3280A
n=1 Participants
Carboplatin AUC 5 iv on day 1 every 21 days for 4 cycles Etoposide 100mg/m2 iv on days 1-3 every 21 days for 4 cycles MPDL3280A (Atezolizumab) 1200mg iv on day 1 every 21 days until progression
Carboplatin: Standard chemotherapy
Etoposide: Standard chemotherapy
MPDL3280A: Experimental biologic
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
—
|
58 years
STANDARD_DEVIATION 0 • n=7 Participants
|
58 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
—
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years.Disease progression will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and bone scans.
Outcome measures
| Measure |
Carboplatin, Etoposide and MPDL3280A
n=1 Participants
Carboplatin AUC 5 iv on day 1 every 21 days for 4 cycles Etoposide 100mg/m2 iv on days 1-3 every 21 days for 4 cycles MPDL3280A (Atezolizumab) 1200mg iv on day 1 every 21 days until progression
Carboplatin: Standard chemotherapy
Etoposide: Standard chemotherapy
MPDL3280A: Experimental biologic
|
|---|---|
|
Progression Free Survival (PFS) With Carboplatin, Etoposide and MPDL3280A Compared to Chemotherapy Alone According to RECIST v1.1
|
6 months
Standard Deviation 0
|
Adverse Events
Carboplatin, Etoposide and MPDL3280A
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carboplatin, Etoposide and MPDL3280A
n=1 participants at risk
Carboplatin AUC 5 iv on day 1 every 21 days for 4 cycles Etoposide 100mg/m2 iv on days 1-3 every 21 days for 4 cycles MPDL3280A (Atezolizumab) 1200mg iv on day 1 every 21 days until progression
Carboplatin: Standard chemotherapy
Etoposide: Standard chemotherapy
MPDL3280A: Experimental biologic
|
|---|---|
|
General disorders
Headache
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. For the single subject enrolled, this amounted to 6.5 months.
|
Other adverse events
| Measure |
Carboplatin, Etoposide and MPDL3280A
n=1 participants at risk
Carboplatin AUC 5 iv on day 1 every 21 days for 4 cycles Etoposide 100mg/m2 iv on days 1-3 every 21 days for 4 cycles MPDL3280A (Atezolizumab) 1200mg iv on day 1 every 21 days until progression
Carboplatin: Standard chemotherapy
Etoposide: Standard chemotherapy
MPDL3280A: Experimental biologic
|
|---|---|
|
General disorders
Infusion reaction
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. For the single subject enrolled, this amounted to 6.5 months.
|
|
Gastrointestinal disorders
Anorexia
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. For the single subject enrolled, this amounted to 6.5 months.
|
|
General disorders
Headache
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. For the single subject enrolled, this amounted to 6.5 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgias
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. For the single subject enrolled, this amounted to 6.5 months.
|
|
General disorders
Night Sweats
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. For the single subject enrolled, this amounted to 6.5 months.
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. For the single subject enrolled, this amounted to 6.5 months.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. For the single subject enrolled, this amounted to 6.5 months.
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. For the single subject enrolled, this amounted to 6.5 months.
|
|
Blood and lymphatic system disorders
Hypokalemia
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. For the single subject enrolled, this amounted to 6.5 months.
|
|
Hepatobiliary disorders
Increased bilirubin
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. For the single subject enrolled, this amounted to 6.5 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. For the single subject enrolled, this amounted to 6.5 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. For the single subject enrolled, this amounted to 6.5 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. For the single subject enrolled, this amounted to 6.5 months.
|
|
Nervous system disorders
Neuropathy
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. For the single subject enrolled, this amounted to 6.5 months.
|
|
Hepatobiliary disorders
ALT Elevation
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. For the single subject enrolled, this amounted to 6.5 months.
|
|
General disorders
Dizziness
|
100.0%
1/1 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. For the single subject enrolled, this amounted to 6.5 months.
|
Additional Information
Dr Giuseppe Giaccone
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
Phone: 202-687-7072
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place