Trial · NCT03325816
Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer
NCT03325816, Phase 1, Phase 2, Completed, Georgetown University; results first posted 2021-03-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer. Trials, record NCT03325816. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03325816
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer
- NCT number
- NCT03325816
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Georgetown University
- Conditions
- Small Cell Lung Cancer, Small Cell Lung Cancer Extensive Stage
- Interventions
- Nivolumab, 177Lu-DOTA0-Tyr3-Octreotate
- First posted
- 2017-10-30
- Last updated
- 2021-03-16
- Results first posted
- 2021-03-16
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I - Recommended Phase II Dose (RP2D) of 177Lu-DOTA0-Tyr3-Octreotate | 12 months | Maximum tolerated dose of 177Lu-DOTA0-Tyr3-Octreotate as determined during the phase I portion. |
| Primary | Phase II - Progression Free Survival | 12 months | Time between start of treatment and tumor progression or death |
| Secondary | Number of Participants With Treatment Related Adverse Events | 24 months | Adverse events and serious adverse events experienced by subjects |
| Secondary | Phase II - Overall Survival | 24 months | Time between start of treatment and death |
| Secondary | Phase II - Disease Control Rate | 12 months | The percentage of patients who achieve complete response, partial response and stable disease |
| Secondary | Phase II - Objective Response Rate | 12 months | The proportion of patients with tumor size reduction |
| Secondary | Phase II - Metabolic Response | 12 months | As measured by NETSPOT PET scan |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase I - Recommended Phase II Dose (RP2D) of 177Lu-DOTA0-Tyr3-Octreotate | 12 months | GBq | NUMBER | |
| PRIMARY | Phase II - Progression Free Survival | 12 months | Phase II outcome- analysis not applicable. Phase II not started per Sponsor decision. | ||
| SECONDARY | Number of Participants With Treatment Related Adverse Events | 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Phase II - Overall Survival | 24 months | Phase II outcome- analysis not applicable. Phase II not started per Sponsor decision. | ||
| SECONDARY | Phase II - Disease Control Rate | 12 months | Phase II outcome- analysis not applicable. Phase II not started per Sponsor decision. | ||
| SECONDARY | Phase II - Objective Response Rate | 12 months | Phase II outcome- analysis not applicable. Phase II not started per Sponsor decision. | ||
| SECONDARY | Phase II - Metabolic Response | 12 months | Phase II outcome- analysis not applicable. Phase II not started per Sponsor decision. |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase I - Recommended Phase II Dose (RP2D) of 177Lu-DOTA0-Tyr3-Octreotate | Phase I | 7.4 | GBq | ||
| Number of Participants With Treatment Related Adverse Events | Phase I - Dose Level -1 | 3 | Participants | ||
| Number of Participants With Treatment Related Adverse Events | Phase I - Dose Level 0 | 6 | Participants |
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 | Phase I - Dose Level -1 | 3 | |
| Overall Study | STARTED | Phase I - Dose Level 0 | 6 | |
| Overall Study | COMPLETED | Phase I - Dose Level -1 | 3 | |
| Overall Study | COMPLETED | Phase I - Dose Level 0 | 6 | |
| Overall Study | NOT COMPLETED | Phase I - Dose Level -1 | 0 | |
| Overall Study | NOT COMPLETED | Phase I - Dose Level 0 | 0 |
Source ClinicalTrials.gov
Adverse events102
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 | Abdominal Pain | Gastrointestinal disorders | Phase I - Dose Level -1 | 1 | 3 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Phase I - Dose Level 0 | 1 | 6 | 1 |
| other | Alanine aminotransferase increased | Investigations | Phase I - Dose Level -1 | 1 | 3 | 1 |
| other | Alanine aminotransferase increased | Investigations | Phase I - Dose Level 0 | 2 | 6 | 2 |
| other | Alkaline phosphatase increased | Investigations | Phase I - Dose Level -1 | 0 | 3 | 0 |
| other | Alkaline phosphatase increased | Investigations | Phase I - Dose Level 0 | 1 | 6 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Phase I - Dose Level -1 | 1 | 3 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Phase I - Dose Level 0 | 2 | 6 | 4 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Phase I - Dose Level -1 | 1 | 3 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Phase I - Dose Level 0 | 1 | 6 | 1 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I - Dose Level -1 | 0 | 3 |
| Total, all-cause mortality | Phase I - Dose Level 0 | 0 | 6 |
| Total, other adverse events | Phase I - Dose Level -1 | 3 | 3 |
| Total, other adverse events | Phase I - Dose Level 0 | 6 | 6 |
| Total, serious adverse events | Phase I - Dose Level -1 | 2 | 3 |
| Total, serious adverse events | Phase I - Dose Level 0 | 2 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32616557 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Phase I - Dose Level -1 vs Phase I - Dose Level 0: Number of Participants With Treatment Related Adverse Events | Trial comparisons |
| Phase I - Dose Level -1 vs Phase I - Dose Level 0: deaths from any cause | Trial comparisons |
| Phase I - Dose Level -1 vs Phase I - Dose Level 0: 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/NCT03325816
GET https://conductscience.org/api/trials/v1/NCT03325816/events?page=2