Trial Outcomes & Findings for Safety and Efficacy Study of Nab®-Paclitaxel With CC-486 or Nab®-Paclitaxel With Durvalumab, and Nab®-Paclitaxel Monotherapy as Second/Third-line Treatment for Advanced Non-small Cell Lung Cancer (NCT NCT02250326)

Last Updated: 2024-09-19

Results Overview

Progression-free survival was defined as the time in months from the date of randomization/assignment to the date of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria documented by computed tomography (CT) scan, not including symptomatic deterioration, or death (any cause) on or prior to the clinical cut-off date, which ever occurred earlier. Participants who did not have disease progression and had not died, regardless of whether they were discontinued from treatment, were censored at the date of last tumor assessment, on or prior to the clinical cut-off date that the participant was progression free. Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions from nadir.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

240 participants

Primary outcome timeframe

From date of first dose of IP to DP; up to data cut-off date of 30 August (Aug) 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 December (Dec) 2017 for Durva + nab-paclitaxel; participants were followed for PFS for up to 18 months

Results posted on

2024-09-19

Participant Flow

Eligible participants included those with advanced non-small cell lung cancer who had received no more than one prior containing chemotherapy regimen. Immunotherapy as a prior line of treatment was allowed. Randomization was stratified by eastern cooperative oncology group performance status, gender and the smoking status of the participant.

Participant milestones

Participant milestones
Measure	Nab-Paclitaxel + CC-486 Participants received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15. CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel + Durvalumab Participants received nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8. Durvalumab (durva) 1125 mg/m\^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel Participants received nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Pre-treatment STARTED	81	79	80
Pre-treatment COMPLETED	79	78	79
Pre-treatment NOT COMPLETED	2	1	1
Treatment STARTED	79	78	79
Treatment COMPLETED	0	0	0
Treatment NOT COMPLETED	79	78	79
Extension Period STARTED	0	4	0
Extension Period COMPLETED	0	0	0
Extension Period NOT COMPLETED	0	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Nab-Paclitaxel + CC-486 Participants received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15. CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel + Durvalumab Participants received nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8. Durvalumab (durva) 1125 mg/m\^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel Participants received nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Treatment Death	1	13	2
Treatment Adverse Event	8	8	9
Treatment Progressive Disease	42	40	47
Treatment Symptomatic Deterioration	9	4	10
Treatment Withdrawal by Subject	11	6	4
Treatment Other reasons	8	7	7
Extension Period Progressive Disease	0	2	0
Extension Period Withdrawal by Subject	0	1	0
Extension Period Withdrawal by investigator	0	1	0

Baseline Characteristics

Safety and Efficacy Study of Nab®-Paclitaxel With CC-486 or Nab®-Paclitaxel With Durvalumab, and Nab®-Paclitaxel Monotherapy as Second/Third-line Treatment for Advanced Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nab-Paclitaxel + CC-486 n=81 Participants Participants received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15. CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel + Durvalumab n=79 Participants Participants received nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8. Durvalumab (durva) 1125 mg/m\^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel n=80 Participants Participants received nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Total n=240 Participants Total of all reporting groups
Age, Continuous	64.0 years STANDARD_DEVIATION 9.00 • n=5 Participants	62.7 years STANDARD_DEVIATION 10.74 • n=7 Participants	62.6 years STANDARD_DEVIATION 9.58 • n=5 Participants	63.1 years STANDARD_DEVIATION 9.77 • n=4 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	25 Participants n=7 Participants	30 Participants n=5 Participants	86 Participants n=4 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	54 Participants n=7 Participants	50 Participants n=5 Participants	154 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	67 Participants n=5 Participants	73 Participants n=7 Participants	66 Participants n=5 Participants	206 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	0 Participants n=7 Participants	11 Participants n=5 Participants	24 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	67 Participants n=5 Participants	77 Participants n=7 Participants	63 Participants n=5 Participants	207 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	1 Participants n=7 Participants	13 Participants n=5 Participants	28 Participants n=4 Participants

PRIMARY outcome

Timeframe: From date of first dose of IP to DP; up to data cut-off date of 30 August (Aug) 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 December (Dec) 2017 for Durva + nab-paclitaxel; participants were followed for PFS for up to 18 months

Population: Intent to Treat Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + CC-486 n=81 Participants Participants received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15. CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel + Durvalumab n=79 Participants Participants received nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8. Durvalumab (durva) 1125 mg/m\^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel Alone n=80 Participants Participants received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Kaplan Meier Estimate of Progression-Free Survival (PFS) as Assessed by the Investigator	3.2 months Interval 2.3 to 4.3	4.5 months Interval 3.45 to 5.88	4.2 months Interval 2.79 to 5.06

SECONDARY outcome

Timeframe: Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel

Population: ITT Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.

Disease control rate was defined as the percentage of participants who had a CR, PR or SD during the course of the study, according to RECIST version 1.1 criteria, as evaluated by the investigator. RECIST Version 1.1 criteria is defined as follows: - Complete Response is the disappearance of all target lesions; - Partial Response is at least a 30% decrease in the sum of diameters of target lesions from baseline; - Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease. Responses were evaluated every 6 weeks.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + CC-486 n=81 Participants Participants received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15. CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel + Durvalumab n=79 Participants Participants received nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8. Durvalumab (durva) 1125 mg/m\^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel Alone n=80 Participants Participants received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to RECIST V 1.1 Criteria	65.4 Percentage of Participants Interval 54.0 to 75.7	70.9 Percentage of Participants Interval 59.6 to 80.6	67.5 Percentage of Participants Interval 56.1 to 77.6

SECONDARY outcome

Population: ITT Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.

Overall Response was defined as percentage of participants who achieved a radiologic confirmed complete response or partial response according to RECIST V 1.1 criteria and compared with baseline among all tumor assessments, where baseline was the last CT obtained prior to or on Day 1 of treatment. Per RECIST V 1.1 criteria, a CR is defined as a disappearance of all target lesions; a PR is defined as having at least a 30% decrease in the sum of diameters of target lesions from baseline. Responses were evaluated every 6 weeks.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + CC-486 n=81 Participants Participants received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15. CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel + Durvalumab n=79 Participants Participants received nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8. Durvalumab (durva) 1125 mg/m\^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel Alone n=80 Participants Participants received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response According to RECIST V 1.1 Criteria	13.6 percentage of participants Interval 7.0 to 23.0	27.8 percentage of participants Interval 18.3 to 39.1	16.3 percentage of participants Interval 8.9 to 26.2

SECONDARY outcome

Timeframe: Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; participants were followed for overall survival up to 30 months

Population: ITT Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.

Overall survival was defined as the time in months between randomization/treatment assignment and death from any cause. Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + CC-486 n=81 Participants Participants received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15. CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel + Durvalumab n=79 Participants Participants received nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8. Durvalumab (durva) 1125 mg/m\^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel Alone n=80 Participants Participants received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Kaplan Meier Estimate of Overall Survival (OS)	8.1 Months Interval 6.64 to 11.86	10.1 Months Interval 7.75 to The 95% CI upper bound of the median OS time is not estimable, because the survival rate is greater than 40% for all values of time, therefore, no time that corresponding to the 40% survival rate and below.	17.0 Months Interval 8.21 to The 95% CI upper bound of the median OS time is not estimable, because the survival rate is greater than 40% for all values of time, therefore, no time that corresponding to the 40% survival rate and below.

SECONDARY outcome

Timeframe: TEAEs were collected up to 4 weeks after receiving last dose of investigational product (IP) for nab-paclitaxel and CC-486 + nab-paclitaxel, and up to 90 days after the last IP dose for Durva + nab-paclitaxel; TEAEs were collected up to 354 weeks

Population: Safety Population included all participants who were randomized and received at least 1 dose of study drug

TEAEs were defined as any adverse event or serious adverse event that occurred or worsened on or after the day of the first dose of the IP through 28 days after the last dose of IP for Arms A and C or up to 90 days after the last dose for Arm B, and those SAEs made known to the investigator at any time thereafter that are suspected of being related to IP. A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild l intervention/therapy required Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + CC-486 n=79 Participants Participants received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15. CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel + Durvalumab n=78 Participants Participants received nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8. Durvalumab (durva) 1125 mg/m\^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel Alone n=79 Participants Participants received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period TEAE	79 Participants	78 Participants	78 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period Serious TEAE	30 Participants	44 Participants	30 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period Grade (GR) 3/4 TEAE	48 Participants	57 Participants	47 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period Grade 3 or Higher	49 Participants	59 Participants	47 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period Treatment Related TEAE	74 Participants	72 Participants	68 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period Treatment Related Serious TEAE	11 Participants	20 Participants	5 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period Treatment Related GR 3 or Higher TEAE	32 Participants	36 Participants	25 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period TEAE With Action to Reduce/Interrupt IP	49 Participants	59 Participants	38 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period Treatment-Related to Reduce or Interrupt IP	36 Participants	36 Participants	27 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period Treatment Related TEAE with Action Taken to Withdraw IP	6 Participants	10 Participants	9 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period TEAE with Fatal Outcome	4 Participants	12 Participants	3 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period Treatment Related TEAE with Fatal Outcome	0 Participants	4 Participants	1 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period TEAE with Action Taken to Withdraw IP	8 Participants	11 Participants	9 Participants

SECONDARY outcome

Timeframe: Up to 30 Aug 2017 for CC-486 + nab-paclitaxel and 26 Nov 2019 for nab-paclitaxe and 20 Jul 2023 for Durva + nab-paclitaxel (up to 445 weeks)

Population: Safety Population included all participants who were randomized and received at least 1 dose of study drug

The discontinuation rate was defined as the percentage of participants who had study drug discontinued and was assessed throughout the conduct of the study.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + CC-486 n=79 Participants Participants received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15. CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel + Durvalumab n=78 Participants Participants received nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8. Durvalumab (durva) 1125 mg/m\^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel Alone n=79 Participants Participants received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Percentage of Participants Who Discontinued Study Treatment	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants

SECONDARY outcome

Population: The treated population consisted of all participants who were randomized or assigned and received at least 1 dose of IP.

Dose intensity was the cumulative dose divided by the dosing period in weeks.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + CC-486 n=79 Participants Participants received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15. CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel + Durvalumab n=78 Participants Participants received nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8. Durvalumab (durva) 1125 mg/m\^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel Alone n=79 Participants Participants received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Dose Intensity Per Week of Nab-Paclitaxel	54.73 mg/m^2/week Standard Deviation 11.390	57.18 mg/m^2/week Standard Deviation 13.605	58.61 mg/m^2/week Standard Deviation 14.893

SECONDARY outcome

Population: The treated population consisted of all participants who randomized or assigned and received at least 1 dose of IP.

Dose intensity was the cumulative dose divided by the dosing period in weeks.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + CC-486 n=79 Participants Participants received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15. CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel + Durvalumab Participants received nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8. Durvalumab (durva) 1125 mg/m\^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel Alone Participants received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Dose Intensity Per Week of CC-486	716.66 mg/ week Standard Deviation 220.945	—	—

SECONDARY outcome

Population: The treated population consisted of all participants who randomized or assigned and received at least 1 dose of investigational Product.

Dose intensity was the cumulative dose divided by the dosing period in weeks.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + CC-486 n=77 Participants Participants received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15. CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel + Durvalumab Participants received nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8. Durvalumab (durva) 1125 mg/m\^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel Alone Participants received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Dose Intensity Per Week of Durvalumab	279.96 mg/week Standard Deviation 97.304	—	—

SECONDARY outcome

Timeframe: Up to 16 Jan 2017 for CC-486 + nab-paclitaxel and up to 26 Nov 2019 for nab-paclitaxel and Durva + nab-paclitaxel (up to 255 weeks)

Population: Safety Population included all participants who were randomized and received at least 1 dose of study drug

A dose reduction occurred when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions were typically caused by clinically significant laboratory abnormalities and/or treatment emergent adverse events or toxicities.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel + CC-486 n=79 Participants Participants received nab-paclitaxel 100 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15. CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel + Durvalumab n=78 Participants Participants received nab-paclitaxel 100 mg/m\^2 by IV infusion over 30 minutes on Days 1 and 8. Durvalumab (durva) 1125 mg/m\^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.	Nab-Paclitaxel Alone n=79 Participants Participants received nab-paclitaxel 100 mg/m\^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Percentage of Participants With Study Drug Dose Reductions Nab-Paclitaxel	10.1 Percentage of Participants	14.1 Percentage of Participants	10.1 Percentage of Participants
Percentage of Participants With Study Drug Dose Reductions CC-486	20.3 Percentage of Participants	—	—
Percentage of Participants With Study Drug Dose Reductions Durvalumab (Reductions Not Allowed per Protocol)	—	0.0 Percentage of Participants	—

Adverse Events

Nab-Paclitaxel + CC-486

Serious events: 30 serious events

Other events: 77 other events

Deaths: 62 deaths

Nab-Paclitaxel + Durvalumab

Serious events: 44 serious events

Other events: 75 other events

Deaths: 48 deaths

Nab-Paclitaxel

Serious events: 30 serious events

Other events: 75 other events

Deaths: 50 deaths

Serious adverse events

Other adverse events

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER