Trial · NCT04063163
A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC
NCT04063163, Phase 3, Completed, Shanghai Henlius Biotech; results first posted 2025-12-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC. Trials, record NCT04063163. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04063163
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC
- NCT number
- NCT04063163
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 585 participants, actual
- Lead sponsor
- Shanghai Henlius Biotech
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Interventions
- HLX10, carboplatin and etoposide, placebo
- First posted
- 2019-08-21
- Last updated
- 2025-12-09
- Results first posted
- 2025-12-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | OS | The period from randomization through death regardless of causality (up to approximately 56 months) | Overall survival (OS) |
| Secondary | Progression Free Survival (PFS) Assessed by IRRC According to RECIST 1.1 | From randomization initiation to the first documentation of PD or death regardless of causality, whichever occurs first (up to approximately 56 months). | PFS is defined as a period from randomization initiation to the first documentation of PD or death regardless of causality (whichever occurs first). |
| Secondary | Objective Response Rate | From baseline until PR or CR, whichever occurs first (up to approximately 56 months) | The ORR is defined as the proportion of subjects with a best overall response of CR or PR, according to RECIST 1.1. The best overall response will be defined as the best response across all time points in the order of CR, PR, SD, PD, and not NE. |
| Secondary | Duration of Response | From the first documentation of response (CR or PR) through the first documentation of PD or death, whichever occurs first (up to approximately 56 months). | DOR is defined as a period from the first documentation of response (CR or PR) through the first documentation of PD or death (whichever occurs first). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | OS | The period from randomization through death regardless of causality (up to approximately 56 months) | Analyses of the primary efficacy endpoint is based on the ITT. The ITT Population comprises all participants to whom study intervention has been randomized. | month | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) Assessed by IRRC According to RECIST 1.1 | From randomization initiation to the first documentation of PD or death regardless of causality, whichever occurs first (up to approximately 56 months). | Analysis of PFS is based on ITT. | month | MEDIAN |
| SECONDARY | Objective Response Rate | From baseline until PR or CR, whichever occurs first (up to approximately 56 months) | ORR is analyzed based on ITT. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response | From the first documentation of response (CR or PR) through the first documentation of PD or death, whichever occurs first (up to approximately 56 months). | DOR is analyzed based on ITT. | month | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| OS | A Groups | 15.77 | 95% Confidence Interval 13.897 to 17.413 | month | |
| OS | B Groups | 11.10 | 95% Confidence Interval 9.955 to 12.353 | month | |
| Progression Free Survival (PFS) Assessed by IRRC According to RECIST 1.1 | A Groups | 5.82 | 95% Confidence Interval 5.552 to 6.932 | month | |
| Progression Free Survival (PFS) Assessed by IRRC According to RECIST 1.1 | B Groups | 4.34 | 95% Confidence Interval 4.205 to 4.435 | month | |
| Objective Response Rate | A Groups | 268 | Participants | ||
| Objective Response Rate | B Groups | 115 | Participants | ||
| Duration of Response | A Groups | 6.80 | 95% Confidence Interval 5.520 to 8.345 | month | |
| Duration of Response | B Groups | 4.17 | 95% Confidence Interval 3.055 to 4.205 | month |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A | 389 | |
| Overall Study | STARTED | Group B | 196 | |
| Overall Study | COMPLETED | Group A | 77 | |
| Overall Study | COMPLETED | Group B | 12 | |
| Overall Study | NOT COMPLETED | Group A | 312 | |
| Overall Study | NOT COMPLETED | Group B | 184 |
Source ClinicalTrials.gov
Adverse events376
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 | Anaemia | Blood and lymphatic system disorders | Group A | 279 | 389 | |
| other | Anaemia | Blood and lymphatic system disorders | Group B | 139 | 196 | |
| other | Neutropenia | Blood and lymphatic system disorders | Group A | 115 | 389 | |
| other | Neutropenia | Blood and lymphatic system disorders | Group B | 59 | 196 | |
| other | Leukopenia | Blood and lymphatic system disorders | Group A | 93 | 389 | |
| other | Leukopenia | Blood and lymphatic system disorders | Group B | 39 | 196 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Group A | 70 | 389 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Group B | 27 | 196 | |
| other | Neutrophil count decreased | Investigations | Group A | 217 | 389 | |
| other | Neutrophil count decreased | Investigations | Group B | 96 | 196 |
1 to 10 of 376Source ClinicalTrials.gov
See all 376 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A | 224 | 389 |
| Total, all-cause mortality | Group B | 140 | 196 |
| Total, other adverse events | Group A | 367 | 389 |
| Total, other adverse events | Group B | 187 | 196 |
| Total, serious adverse events | Group A | 146 | 389 |
| Total, serious adverse events | Group B | 71 | 196 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| A Groups vs B Groups: Objective Response Rate | Trial comparisons |
| Group A vs Group B: deaths from any cause | Trial comparisons |
| Group A vs Group B: 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/NCT04063163
GET https://conductscience.org/api/trials/v1/NCT04063163/events?page=2