Trial Outcomes & Findings for Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (NCT NCT05089734)

Last Updated: 2025-05-23

Results Overview

OS is defined as the time from the date of randomization until the date of death from any cause. OS was estimated using Kaplan-Meier estimate. Participants without documentation of death were censored on the date they were last known to be alive.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

603 participants

Primary outcome timeframe

Up to 24.4 months

Results posted on

2025-05-23

Participant Flow

Participants were enrolled at study sites in Europe, North America, Brazil, Israel, Japan, Turkey, Australia, and Puerto Rico.

784 participants were screened. Data submitted represent interim analysis performed on data collected by the Primary Completion Date. Complete data will be submitted in May 2026.

Participant milestones

Participant milestones
Measure	Sacituzumab Govitecan (SG) Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months).	Docetaxel Participants received docetaxel 75 mg/m\^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months).
Overall Study STARTED	299	304
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	299	304

Reasons for withdrawal

Reasons for withdrawal
Measure	Sacituzumab Govitecan (SG) Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months).	Docetaxel Participants received docetaxel 75 mg/m\^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months).
Overall Study Still on study	122	101
Overall Study Death	161	179
Overall Study Withdrew consent	11	24
Overall Study Lost to Follow-up	5	0

Baseline Characteristics

Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sacituzumab Govitecan (SG) n=299 Participants Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months).	Docetaxel n=304 Participants Participants received docetaxel 75 mg/m\^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months).	Total~(N=584) n=603 Participants
Age, Continuous	65 years STANDARD_DEVIATION 9.2 • n=5 Participants	64 years STANDARD_DEVIATION 9.3 • n=7 Participants	64 years STANDARD_DEVIATION 9.3 • n=5 Participants
Age, Customized Between 18 and 65 years	136 Participants n=5 Participants	161 Participants n=7 Participants	297 Participants n=5 Participants
Age, Customized >=65 years	163 Participants n=5 Participants	143 Participants n=7 Participants	306 Participants n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	88 Participants n=7 Participants	193 Participants n=5 Participants
Sex: Female, Male Male	194 Participants n=5 Participants	216 Participants n=7 Participants	410 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	17 Participants n=5 Participants	26 Participants n=7 Participants	43 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	229 Participants n=5 Participants	216 Participants n=7 Participants	445 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Race · Not Reported	44 Participants n=5 Participants	49 Participants n=7 Participants	93 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	266 Participants n=5 Participants	268 Participants n=7 Participants	534 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Not Reported	9 Participants n=5 Participants	14 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment Spain	73 Participants n=5 Participants	66 Participants n=7 Participants	139 Participants n=5 Participants
Region of Enrollment France	55 Participants n=5 Participants	65 Participants n=7 Participants	120 Participants n=5 Participants
Region of Enrollment United States	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants
Region of Enrollment Japan	15 Participants n=5 Participants	22 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment Italy	20 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants
Region of Enrollment Germany	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment Greece	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment Turkey	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment Australia	6 Participants n=5 Participants	14 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United Kingdom	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment Canada	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment Netherlands	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment Brazil	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment Belgium	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment Portugal	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment Austria	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Poland	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment Israel	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Mexico	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24.4 months

Population: The Intent to Treat (ITT) Analysis Set included all randomized participants according to the treatment arm to which the participant was randomized.

Outcome measures

Outcome measures
Measure	Sacituzumab Govitecan (SG) n=299 Participants Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months).	Docetaxel n=304 Participants Participants received docetaxel 75 mg/m\^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months).
Overall Survival (OS)	11.1 months Interval 9.4 to 12.3	9.8 months Interval 8.1 to 10.6

SECONDARY outcome

Timeframe: Up to 24.4 months

Population: Participants in the ITT Analysis Set were analyzed.

PFS is defined as the time from the date of randomization until the date of objective disease progression (PD) or death from any cause, whichever occurs first as assessed by RECIST v.1.1. As per RECIST 1.1, PD was defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or the appearance of of 1 or more new lesions or unequivocal progression of existing non-target lesions. Participants who did not have documented disease progression and did not die were censored at their last tumor assessment date. Kaplan-Meier estimate was used for analysis.

Outcome measures

Outcome measures
Measure	Sacituzumab Govitecan (SG) n=299 Participants Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months).	Docetaxel n=304 Participants Participants received docetaxel 75 mg/m\^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months).
Progression-free Survival (PFS) Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	4.1 months Interval 3.0 to 4.4	3.9 months Interval 3.1 to 4.2

SECONDARY outcome

Timeframe: Up to 24.4 months

Population: Participants in the ITT Analysis Set were analyzed.

ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) that was confirmed at least 4 weeks later as assessed by RECIST v.1.1. As per RECIST 1.1 CR was defined as: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR was defined as: At least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Outcome measures

Outcome measures
Measure	Sacituzumab Govitecan (SG) n=299 Participants Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months).	Docetaxel n=304 Participants Participants received docetaxel 75 mg/m\^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months).
Objective Response Rate (ORR) Assessed by Investigator Per RECIST Version 1.1	13.7 percentage of participants Interval 10.0 to 18.1	18.1 percentage of participants Interval 13.9 to 22.9

SECONDARY outcome

Timeframe: Up to 24.4 months

Population: Participants in the ITT Population who achieved confirmed complete or partial response were analyzed.

DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of PD or death from any cause (whichever comes first) as assessed by RECIST v. 1.1. As per RECIST 1.1 CR was disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR was at least 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, and PD was at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or the appearance of of 1 or more new lesions or unequivocal progression of existing non-target lesions. Kaplan-Meier estimate was used for analysis.

Outcome measures

Outcome measures
Measure	Sacituzumab Govitecan (SG) n=41 Participants Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months).	Docetaxel n=55 Participants Participants received docetaxel 75 mg/m\^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months).
Duration of Response (DOR) Assessed by Investigator Per RECIST Version 1.1	6.7 months Interval 4.4 to 9.8	5.8 months Interval 4.1 to 8.3

SECONDARY outcome

Timeframe: Up to 24.4 months

Population: Participants in the ITT Analysis Set were analyzed.

DCR was defined as the percentage of participants who achieved a CR, PR,or stable disease(SD)as assessed by RECIST v.1.1. Per RECIST 1.1 CR was disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal;PR was at least 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum LD since the treatment started and persistence of 1 or more nontarget lesion(s).PD was at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study),in addition of increase of 20% sum also demonstrate an absolute increase of at least 5 mm or appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	Sacituzumab Govitecan (SG) n=299 Participants Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months).	Docetaxel n=304 Participants Participants received docetaxel 75 mg/m\^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months).
Disease Control Rate (DCR) Assessed by Investigator Per RECIST Version 1.1	67.6 percentage of participants Interval 61.9 to 72.8	67.1 percentage of participants Interval 61.5 to 72.4

SECONDARY outcome

Timeframe: Up to 3.5 years

An AE was defined as any untoward medical occurrence in a participants administered a medicinal product that does not necessarily have a causal relationship with this treatment. TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of the study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3.5 years

Blood samples were collected for hematology, serum chemistry, and the laboratory abnormalities were assessed. A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose plus 30 days.The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 will be reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24.4 months

Population: Participants in the ITT Analysis Set were analyzed.

The NSCLC-SAQ is a participant reported outcome with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No \<symptom\> At All" to "Very severe \<symptom\>" or from "Never to Always" depending on the item's question structure relative to either intensity or frequency, corresponding to a score of 0 to 4, with total score ranging from 0 to 20. The dyspnea (shortness of breath) item uses a "Never(0) to Always(4)" rating scale with higher score indicating higher frequency of dyspnea. Time to deterioration (TTD) was defined as the time from date of randomization to the first date a participant achieves 2-point deterioration from baseline. For shortness of breath domain, a 1-point or greater worsening from baseline represents a clinically meaningful deterioration. Kaplan-Meier estimate was used for analysis.

Outcome measures

Outcome measures
Measure	Sacituzumab Govitecan (SG) n=299 Participants Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months).	Docetaxel n=304 Participants Participants received docetaxel 75 mg/m\^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months).
Time to First Deterioration in Shortness of Breath Domain as Measured by Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)	2.8 months Interval 2.2 to 4.0	2.1 months Interval 1.6 to 2.9

SECONDARY outcome

Timeframe: Up to 24.4 months

Population: Participants in the ITT Analysis Set were analyzed.

The NSCLC-SAQ is a participant reported outcome measure with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No \<symptom\> At All" to "Very severe \<symptom\>" or from "Never to Always" depending on the item's question structure relative to either intensity or frequency, corresponding to a score of 0 to 4. A total score sums all five domain scores at each visit. If any domain score was missing, the score was not computed. The total score ranges between 0 and 20, with higher scores indicating more severe symptoms. TTD was defined as the time from date of randomization to the first date a participant achieves 2-point deterioration from baseline. For NSCLC-SAQ total score, a 2-point or greater worsening from baseline represents a clinically meaningful deterioration. Kaplan-Meier estimate was used for analysis.

Outcome measures

Outcome measures
Measure	Sacituzumab Govitecan (SG) n=299 Participants Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months).	Docetaxel n=304 Participants Participants received docetaxel 75 mg/m\^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months).
Time to First Deterioration in NSCLC-SAQ Total Score	3.1 months Interval 2.5 to 3.9	2.7 months Interval 2.1 to 3.5

Adverse Events

Sacituzumab Govitecan (SG)

Serious events: 137 serious events

Other events: 283 other events

Deaths: 168 deaths

Docetaxel

Serious events: 124 serious events

Other events: 267 other events

Deaths: 187 deaths

Serious adverse events

Other adverse events

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER