NCT02546986 · FLOW

Participant flow

Safety and Efficacy Study of CC-486 With MK-3475 to Treat Locally Advanced or Metastatic Non-small Cell Lung Cancer · Source last updated 2026-07-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

description
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
id
FG000
title
CC-486 and Pembrolizumab (CC-486 + PBZ)
description
Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
id
FG001
title
Placebo and Pembrolizumab (PBO + PBZ)

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
20
group Id
FG001
num Subjects
22
type
Progressive Disease
reasons
group Id
FG000
num Subjects
14
group Id
FG001
num Subjects
6
type
Adverse Event
reasons
group Id
FG000
num Subjects
4
group Id
FG001
num Subjects
3
type
Symptomatic Deterioration
reasons
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
4
type
Death
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
2
type
Physician Decision
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
type
Protocol Violation
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
1
type
Withdrawal by Subject
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
1
type
Non-compliance with Study Drug
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
1
type
Study Terminated by Sponsor
reasons
group Id
FG000
num Subjects
7
group Id
FG001
num Subjects
9
type
Miscellaneous
milestones
achievements
group Id
FG000
num Subjects
51
group Id
FG001
num Subjects
49
type
STARTED
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
comment
Completed = Not applicable according to the study design
type
COMPLETED
achievements
group Id
FG000
num Subjects
51
group Id
FG001
num Subjects
49
type
NOT COMPLETED
title
Treatment Period
drop Withdraws
reasons
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
5
type
Missing Status
reasons
group Id
FG000
num Subjects
18
group Id
FG001
num Subjects
12
type
Death
reasons
group Id
FG000
num Subjects
13
group Id
FG001
num Subjects
16
type
Alive
reasons
group Id
FG000
num Subjects
2
group Id
FG001
num Subjects
2
type
Lost to Follow-up
milestones
achievements
group Id
FG000
num Subjects
36
group Id
FG001
num Subjects
35
type
STARTED
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
comment
Participants remained in follow-up until withdrawal of consent, death or lost to follow-up
type
COMPLETED
achievements
group Id
FG000
num Subjects
36
group Id
FG001
num Subjects
35
type
NOT COMPLETED
title
Survival Follow-Up Phase

pre Assignment Details

Qualified participants were randomized in a 1:1 ratio to one of the two treatment groups. Randomization was stratified by cancer histology (non-squamous versus squamous).

recruitment Details

This study was a multicenter study with 25 sites from the United States, France. Germany, Italy, and Spain.

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