Trial · NCT03150875
A Study Comparing the Efficacy and Safety Between IBI308 and Docetaxel in Patients With Advanced or Metastatic NSCLC
NCT03150875, Phase 3, Completed, Innovent Biologics (Suzhou) Co. Ltd.; results first posted 2021-06-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Comparing the Efficacy and Safety Between IBI308 and Docetaxel in Patients With Advanced or Metastatic NSCLC. Trials, record NCT03150875. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03150875
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing the Efficacy and Safety Between IBI308 and Docetaxel in Patients With Advanced or Metastatic NSCLC
- NCT number
- NCT03150875
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 290 participants, actual
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- IBI308, Docetaxel
- First posted
- 2017-05-12
- Last updated
- 2023-02-28
- Results first posted
- 2021-06-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Through database cutoff date of 31-July-2020 (up to approximately 35 months) | Overall survival was defined as the time from randomization to death due to any cause. |
| Secondary | Progression-free Survival by Investigators' Assessment | Through database cutoff date of 31-July-2020 (up to approximately 35 months) | Progression-free survival (PFS) was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumours (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions, or unequivocal progression of non-target lesion. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by investigators per RECIST 1.1 was reported for each arm. |
| Secondary | Overall Response Rate (ORR) Per RECIST v1.1 as Assessed by Investigators | Through database cutoff date of 31-July-2020 (up to approximately 35 months) | ORR was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The percentage of participants who experienced a CR or PR is presented. |
| Secondary | Duration of Response (DOR) Per RECIST v1.1 as Assessed by Investigators | Through database cutoff date of 31-July-2020 (up to approximately 35 months) | For participants who demonstrated a CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions or unequivoval progression of non-target lesion. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The DOR per RECIST 1.1 for all participants who experienced a CR or PR is presented. |
| Secondary | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE) | Through database cutoff date of 31-July-2020 (up to approximately 35 months) | TEAE is any AE that developed or worsened in severity compared to the baseline during the period from first dose of any study treatment up to 90 days after the last dose of any study treatment. Percentage of participants experiencing TEAE is calculated. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Through database cutoff date of 31-July-2020 (up to approximately 35 months) | All randomized participants excluding participants in the docetaxel arm who initiated immunotherapy before receiving docetaxel or disease progression. | Months | MEDIAN |
| SECONDARY | Progression-free Survival by Investigators' Assessment | Through database cutoff date of 31-July-2020 (up to approximately 35 months) | All randomized participants excluding participants in the docetaxel arm who initiated immunotherapy before receiving docetaxel or disease progression. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) Per RECIST v1.1 as Assessed by Investigators | Through database cutoff date of 31-July-2020 (up to approximately 35 months) | All randomized participants excluding participants in the docetaxel arm who initiated immunotherapy before receiving docetaxel or disease progression. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Per RECIST v1.1 as Assessed by Investigators | Through database cutoff date of 31-July-2020 (up to approximately 35 months) | All responders | Months | MEDIAN |
| SECONDARY | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE) | Through database cutoff date of 31-July-2020 (up to approximately 35 months) | All participants who received ≥1 dose of study treatment | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Sintilimab | 11.79 | 95% Confidence Interval 10.28 to 15.27 | Months | |
| Overall Survival | Docetaxel | 8.25 | 95% Confidence Interval 6.47 to 9.82 | Months | |
| Progression-free Survival by Investigators' Assessment | Sintilimab | 4.3 | 95% Confidence Interval 4.04 to 5.78 | Months | |
| Progression-free Survival by Investigators' Assessment | Docetaxel | 2.79 | 95% Confidence Interval 1.91 to 3.19 | Months | |
| Overall Response Rate (ORR) Per RECIST v1.1 as Assessed by Investigators | Sintilimab | 25.5 | 95% Confidence Interval 18.6 to 33.4 | Percentage of participants | |
| Overall Response Rate (ORR) Per RECIST v1.1 as Assessed by Investigators | Docetaxel | 2.2 | 95% Confidence Interval 0.5 to 6.4 | Percentage of participants | |
| Duration of Response (DOR) Per RECIST v1.1 as Assessed by Investigators | Sintilimab | 12.45 | 95% Confidence Interval 4.86 to 25.33 | Months | |
| Duration of Response (DOR) Per RECIST v1.1 as Assessed by Investigators | Docetaxel | 4.14 | 95% Confidence Interval 1.41 to 7.23 | Months | |
| Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE) | Sintilimab | 97.20 | Percentage of participants | ||
| Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE) | Docetaxel | 96.20 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sintilimab | 145 | |
| Overall Study | STARTED | Docetaxel | 145 | |
| Overall Study | Treated | Sintilimab | 144 | |
| Overall Study | Treated | Docetaxel | 130 | |
| Overall Study | Crossover to Certain Treatment | Sintilimab | 0 | |
| Overall Study | Crossover to Certain Treatment | Docetaxel | 0 | |
| Overall Study | COMPLETED | Sintilimab | 0 | |
| Overall Study | COMPLETED | Docetaxel | 0 | |
| Overall Study | NOT COMPLETED | Sintilimab | 145 | |
| Overall Study | NOT COMPLETED | Docetaxel | 145 |
Source ClinicalTrials.gov
Adverse events234
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 | Sintilimab | 48 | 144 | |
| other | Anaemia | Blood and lymphatic system disorders | Docetaxel | 43 | 130 | |
| other | Sinus tachycardia | Cardiac disorders | Sintilimab | 12 | 144 | |
| other | Sinus tachycardia | Cardiac disorders | Docetaxel | 7 | 130 | |
| other | Hyperthyroidism | Endocrine disorders | Sintilimab | 11 | 144 | |
| other | Hyperthyroidism | Endocrine disorders | Docetaxel | 0 | 130 | |
| other | Hypothyroidism | Endocrine disorders | Sintilimab | 27 | 144 | |
| other | Hypothyroidism | Endocrine disorders | Docetaxel | 2 | 130 | |
| other | Constipation | Gastrointestinal disorders | Sintilimab | 23 | 144 | |
| other | Constipation | Gastrointestinal disorders | Docetaxel | 14 | 130 |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sintilimab | 108 | 144 |
| Total, all-cause mortality | Docetaxel | 101 | 130 |
| Total, other adverse events | Sintilimab | 132 | 144 |
| Total, other adverse events | Docetaxel | 117 | 130 |
| Total, serious adverse events | Sintilimab | 56 | 144 |
| Total, serious adverse events | Docetaxel | 34 | 130 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36336841 | 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 |
|---|---|
| Sintilimab vs Docetaxel: deaths from any cause | Trial comparisons |
| Sintilimab 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/NCT03150875
GET https://conductscience.org/api/trials/v1/NCT03150875/events?page=2