Trial Outcomes & Findings for Neoadjuvant MPDL3280A, Nab-paclitaxel and Carboplatin (MAC) in NSCLC (NCT NCT02716038)

Last Updated: 2023-12-12

Results Overview

Major pathologic response rate (MPR) is defined as \> or = 90% decrease in viable tumor.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

84 days

Results posted on

2023-12-12

8 patients did not continue after enrollment onto protocol regimen (7 screen fails and 1 subject withdrawal)

Participant milestones
Measure	MPDL3280A, Carboplatin, Nab-paclitaxel Subjects with advanced or recurrent cancers receiving: * MPDL3280A every 21 days for up to 84 days * Carboplatin every 21 days for up to 84 days * Nab-paclitaxel every 7 days for up to 84 days
Overall Study STARTED	31
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	5

Reasons for withdrawal
Measure	MPDL3280A, Carboplatin, Nab-paclitaxel Subjects with advanced or recurrent cancers receiving: * MPDL3280A every 21 days for up to 84 days * Carboplatin every 21 days for up to 84 days * Nab-paclitaxel every 7 days for up to 84 days
Overall Study Not evaluable	1
Overall Study Not brought to surgery due to brain metastasis	1
Overall Study Unresectable	3

Neoadjuvant MPDL3280A, Nab-paclitaxel and Carboplatin (MAC) in NSCLC

Baseline characteristics by cohort
Measure	MPDL3280A, Carboplatin, Nab-paclitaxel n=31 Participants Subjects with advanced or recurrent cancers receiving: * MPDL3280A every 21 days for up to 84 days * Carboplatin every 21 days for up to 84 days * Nab-paclitaxel every 7 days for up to 84 days
Age, Customized 40-49 years	2 Participants n=99 Participants
Age, Customized 50-59 years	3 Participants n=99 Participants
Age, Customized 60-69 years	12 Participants n=99 Participants
Age, Customized 70-79 years	13 Participants n=99 Participants
Age, Customized 80-89 years	1 Participants n=99 Participants
Sex: Female, Male Female	15 Participants n=99 Participants
Sex: Female, Male Male	16 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants
Race (NIH/OMB) White	19 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=99 Participants
Region of Enrollment United States	31 participants n=99 Participants

Timeframe: 84 days

Population: 26 out of 31 enrolled participants had surgery (resectable) and evaluable data.

Major pathologic response rate (MPR) is defined as \> or = 90% decrease in viable tumor.

Outcome measures
Measure	MPDL3280A, Carboplatin, Nab-paclitaxel n=26 Participants Subjects with advanced or recurrent cancers receiving: * MPDL3280A every 21 days for up to 84 days * Carboplatin every 21 days for up to 84 days * Nab-paclitaxel every 7 days for up to 84 days
Number of Subjects With Major Pathologic Response (MPR)	17 Participants

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events
Measure	MPDL3280A, Carboplatin, Nab-paclitaxel n=30 participants at risk Subjects with advanced or recurrent cancers receiving: * MPDL3280A every 21 days for up to 84 days * Carboplatin every 21 days for up to 84 days * Nab-paclitaxel every 7 days for up to 84 days
Blood and lymphatic system disorders Febrile neutropenia	3.3% 1/30 • Up to 48 months for the 31 out of the 39 enrolled/consented had continued onto protocol regimen, and 30 out of 31 had evaluable data (i.e., 1 patient determined not evaluable).
Metabolism and nutrition disorders Hyperglycemia	3.3% 1/30 • Up to 48 months for the 31 out of the 39 enrolled/consented had continued onto protocol regimen, and 30 out of 31 had evaluable data (i.e., 1 patient determined not evaluable).
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	3.3% 1/30 • Up to 48 months for the 31 out of the 39 enrolled/consented had continued onto protocol regimen, and 30 out of 31 had evaluable data (i.e., 1 patient determined not evaluable).

Other adverse events
Measure	MPDL3280A, Carboplatin, Nab-paclitaxel n=30 participants at risk Subjects with advanced or recurrent cancers receiving: * MPDL3280A every 21 days for up to 84 days * Carboplatin every 21 days for up to 84 days * Nab-paclitaxel every 7 days for up to 84 days
Blood and lymphatic system disorders Neutropenia	50.0% 15/30 • Up to 48 months for the 31 out of the 39 enrolled/consented had continued onto protocol regimen, and 30 out of 31 had evaluable data (i.e., 1 patient determined not evaluable).
Investigations Alanine aminotransferase increased	6.7% 2/30 • Up to 48 months for the 31 out of the 39 enrolled/consented had continued onto protocol regimen, and 30 out of 31 had evaluable data (i.e., 1 patient determined not evaluable).
Investigations Aspartate aminotransferase increased	6.7% 2/30 • Up to 48 months for the 31 out of the 39 enrolled/consented had continued onto protocol regimen, and 30 out of 31 had evaluable data (i.e., 1 patient determined not evaluable).
Blood and lymphatic system disorders Thrombocytopenia	6.7% 2/30 • Up to 48 months for the 31 out of the 39 enrolled/consented had continued onto protocol regimen, and 30 out of 31 had evaluable data (i.e., 1 patient determined not evaluable).

Columbia University Irving Medical Center

Phone: 212-305-3997