Trial Outcomes & Findings for Etirinotecan Pegol (NKTR-102) in NSCLC (NCT NCT01773109)
NCT ID: NCT01773109
Last Updated: 2020-04-03
Results Overview
The primary objective of this phase 2 trial is to estimate the objective response rate (Complete Response or Partial Response, as measured by RECIST version 1.1) for patients with metastatic or recurrent NSCLC being treated with etirinotecan pegol after failure of second-line therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
6 weeks
Results posted on
2020-04-03
Participant Flow
Participant milestones
| Measure |
Etirinotecan Pegol
145 mg/m2 will be administered as an IV infusion over a course of 90 minutes on Day 1 of a 21 day cycle
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Etirinotecan Pegol
145 mg/m2 will be administered as an IV infusion over a course of 90 minutes on Day 1 of a 21 day cycle
|
|---|---|
|
Overall Study
Symptomatic Progression
|
2
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Etirinotecan Pegol (NKTR-102) in NSCLC
Baseline characteristics by cohort
| Measure |
Etirinotecan Pegol
n=40 Participants
This Phase II, single-arm, open-label study is designed to investigate the efficacy and safety of etirinotecan pegol in patients with metastatic or recurrent NSCLC after failure of 2nd line therapy. Eligible patients will receive etirinotecan pegol at a dose of 145 mg/m2 iv every 3 weeks. One cycle will be defined as 3 weeks. Patients will be followed clinically every week for the first cycle with laboratory parameters and physical exam. Response will be determined with RECIST version 1.1 after 2 cycles of therapy. Patients with Stable disease (SD), partial response (PR) or complete response (CR) will continue on additional therapy for up to six cycles. In the absence of disease progression in subjects completing six full cycles, further treatment beyond cycle #6 will be left to the discretion of the treating physician and his/her staff. Patients with progressive disease will be taken off study and will be followed for overall survival.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=93 Participants
|
|
Age, Continuous
|
66 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe primary objective of this phase 2 trial is to estimate the objective response rate (Complete Response or Partial Response, as measured by RECIST version 1.1) for patients with metastatic or recurrent NSCLC being treated with etirinotecan pegol after failure of second-line therapy.
Outcome measures
| Measure |
Etirinotecan Pegol
n=37 Participants
This Phase II, single-arm, open-label study is designed to investigate the efficacy and safety of etirinotecan pegol in patients with metastatic or recurrent NSCLC after failure of 2nd line therapy. Eligible patients will receive etirinotecan pegol at a dose of 145 mg/m2 iv every 3 weeks. One cycle will be defined as 3 weeks. Patients will be followed clinically every week for the first cycle with laboratory parameters and physical exam. Response will be determined with RECIST version 1.1 after 2 cycles of therapy. Patients with Stable disease (SD), partial response (PR) or complete response (CR) will continue on additional therapy for up to six cycles. In the absence of disease progression in subjects completing six full cycles, further treatment beyond cycle #6 will be left to the discretion of the treating physician and his/her staff. Patients with progressive disease will be taken off study and will be followed for overall survival.
|
|---|---|
|
Overall Objective Response Rate
Partial Response
|
2 Participants
|
|
Overall Objective Response Rate
Stable Disease
|
17 Participants
|
|
Overall Objective Response Rate
Progressive Disease
|
18 Participants
|
Adverse Events
Etirinotecan Pegol
Serious events: 5 serious events
Other events: 0 other events
Deaths: 37 deaths
Serious adverse events
| Measure |
Etirinotecan Pegol
n=40 participants at risk
Etirinotecan pegol (NKTR-102): 145mg/m2 intravenously every 3 weeks
|
|---|---|
|
Nervous system disorders
Treatment-related seconard maligancy
|
2.5%
1/40 • Number of events 1 • 7 months
As per CTCAE
|
|
Blood and lymphatic system disorders
Sepsis
|
2.5%
1/40 • Number of events 1 • 7 months
As per CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.5%
1/40 • Number of events 1 • 7 months
As per CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.5%
1/40 • Number of events 1 • 7 months
As per CTCAE
|
|
Blood and lymphatic system disorders
Thromboembolic Event
|
2.5%
1/40 • Number of events 1 • 7 months
As per CTCAE
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Charu Aggarwal
University of Pennsylvania (Abramson Cancer Center)
Phone: 2156624000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place