Trial · NCT05089734
Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
NCT05089734, Phase 3, Active not recruiting, Gilead Sciences; results first posted 2025-01-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC). Trials, record NCT05089734. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05089734
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
- NCT number
- NCT05089734
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 603 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Sacituzumab Govitecan-hziy (SG), Docetaxel
- First posted
- 2021-10-22
- Last updated
- 2026-05-07
- Results first posted
- 2025-01-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Up to 24.4 months | 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. |
| Secondary | Progression-free Survival (PFS) Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Up to 24.4 months | 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. |
| Secondary | Objective Response Rate (ORR) Assessed by Investigator Per RECIST Version 1.1 | Up to 24.4 months | 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. |
| Secondary | Duration of Response (DOR) Assessed by Investigator Per RECIST Version 1.1 | Up to 24.4 months | 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. |
| Secondary | Disease Control Rate (DCR) Assessed by Investigator Per RECIST Version 1.1 | Up to 24.4 months | 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. |
| Secondary | Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) | 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. |
| Secondary | Percentage of Participants Who Experienced Grade 3 or 4 Treatment Emergent Laboratory Abnormalities Post-Baseline | 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. |
| Secondary | Time to First Deterioration in Shortness of Breath Domain as Measured by Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) | Up to 24.4 months | 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. |
| Secondary | Time to First Deterioration in NSCLC-SAQ Total Score | Up to 24.4 months | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Up to 24.4 months | The Intent to Treat (ITT) Analysis Set included all randomized participants according to the treatment arm to which the participant was randomized. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Up to 24.4 months | Participants in the ITT Analysis Set were analyzed. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Assessed by Investigator Per RECIST Version 1.1 | Up to 24.4 months | Participants in the ITT Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Assessed by Investigator Per RECIST Version 1.1 | Up to 24.4 months | Participants in the ITT Population who achieved confirmed complete or partial response were analyzed. | months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) Assessed by Investigator Per RECIST Version 1.1 | Up to 24.4 months | Participants in the ITT Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) | Up to 3.5 years | |||
| SECONDARY | Percentage of Participants Who Experienced Grade 3 or 4 Treatment Emergent Laboratory Abnormalities Post-Baseline | Up to 3.5 years | |||
| SECONDARY | Time to First Deterioration in Shortness of Breath Domain as Measured by Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) | Up to 24.4 months | Participants in the ITT Analysis Set were analyzed. | months | MEDIAN |
| SECONDARY | Time to First Deterioration in NSCLC-SAQ Total Score | Up to 24.4 months | Participants in the ITT Analysis Set were analyzed. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Sacituzumab Govitecan (SG) | 11.1 | 95% Confidence Interval 9.4 to 12.3 | months | |
| Overall Survival (OS) | Docetaxel | 9.8 | 95% Confidence Interval 8.1 to 10.6 | months | |
| Progression-free Survival (PFS) Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Sacituzumab Govitecan (SG) | 4.1 | 95% Confidence Interval 3.0 to 4.4 | months | |
| Progression-free Survival (PFS) Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Docetaxel | 3.9 | 95% Confidence Interval 3.1 to 4.2 | months | |
| Objective Response Rate (ORR) Assessed by Investigator Per RECIST Version 1.1 | Sacituzumab Govitecan (SG) | 13.7 | 95% Confidence Interval 10.0 to 18.1 | percentage of participants | |
| Objective Response Rate (ORR) Assessed by Investigator Per RECIST Version 1.1 | Docetaxel | 18.1 | 95% Confidence Interval 13.9 to 22.9 | percentage of participants | |
| Duration of Response (DOR) Assessed by Investigator Per RECIST Version 1.1 | Sacituzumab Govitecan (SG) | 6.7 | 95% Confidence Interval 4.4 to 9.8 | months | |
| Duration of Response (DOR) Assessed by Investigator Per RECIST Version 1.1 | Docetaxel | 5.8 | 95% Confidence Interval 4.1 to 8.3 | months | |
| Disease Control Rate (DCR) Assessed by Investigator Per RECIST Version 1.1 | Sacituzumab Govitecan (SG) | 67.6 | 95% Confidence Interval 61.9 to 72.8 | percentage of participants | |
| Disease Control Rate (DCR) Assessed by Investigator Per RECIST Version 1.1 | Docetaxel | 67.1 | 95% Confidence Interval 61.5 to 72.4 | percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sacituzumab Govitecan (SG) | 299 | |
| Overall Study | STARTED | Docetaxel | 304 | |
| Overall Study | COMPLETED | Sacituzumab Govitecan (SG) | 0 | |
| Overall Study | COMPLETED | Docetaxel | 0 | |
| Overall Study | NOT COMPLETED | Sacituzumab Govitecan (SG) | 299 | |
| Overall Study | NOT COMPLETED | Docetaxel | 304 |
Source ClinicalTrials.gov
Adverse events396
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Sacituzumab Govitecan (SG) | 119 | 296 | |
| other | Anemia | Blood and lymphatic system disorders | Docetaxel | 88 | 288 | |
| other | Leukopenia | Blood and lymphatic system disorders | Sacituzumab Govitecan (SG) | 37 | 296 | |
| other | Leukopenia | Blood and lymphatic system disorders | Docetaxel | 62 | 288 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Sacituzumab Govitecan (SG) | 22 | 296 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Docetaxel | 31 | 288 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sacituzumab Govitecan (SG) | 109 | 296 | |
| other | Neutropenia | Blood and lymphatic system disorders | Docetaxel | 116 | 288 | |
| other | Abdominal pain | Gastrointestinal disorders | Sacituzumab Govitecan (SG) | 27 | 296 | |
| other | Abdominal pain | Gastrointestinal disorders | Docetaxel | 14 | 288 |
1 to 10 of 396Source ClinicalTrials.gov
See all 396 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sacituzumab Govitecan (SG) | 168 | 299 |
| Total, all-cause mortality | Docetaxel | 187 | 304 |
| Total, other adverse events | Sacituzumab Govitecan (SG) | 283 | 296 |
| Total, other adverse events | Docetaxel | 267 | 288 |
| Total, serious adverse events | Sacituzumab Govitecan (SG) | 137 | 296 |
| Total, serious adverse events | Docetaxel | 124 | 288 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38843511 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sacituzumab Govitecan (SG) vs Docetaxel: deaths from any cause | Trial comparisons |
| Sacituzumab Govitecan (SG) vs Docetaxel: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05089734
GET https://conductscience.org/api/trials/v1/NCT05089734/events?page=2