Trial · NCT04560972
LB-100, Carboplatin, Etoposide, and Atezolizumab for the Treatment of Untreated Extensive-Stage Small Cell Lung Cancer
NCT04560972, Phase 1, Active not recruiting, City of Hope Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. LB-100, Carboplatin, Etoposide, and Atezolizumab for the Treatment of Untreated Extensive-Stage Small Cell Lung Cancer. Trials, record NCT04560972. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04560972
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LB-100, Carboplatin, Etoposide, and Atezolizumab for the Treatment of Untreated Extensive-Stage Small Cell Lung Cancer
- NCT number
- NCT04560972
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 3 participants, actual
- Lead sponsor
- City of Hope Medical Center
- Conditions
- Extensive Stage Lung Small Cell Carcinoma
- Interventions
- Atezolizumab, Carboplatin, Etoposide, Protein Phosphatase 2A Inhibitor LB-100
- First posted
- 2020-09-23
- Last updated
- 2026-04-07
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended phase II dose (RP2D) | End of first cycle (21 days) | Measured using dose-limiting toxicity (DLT) during the first cycle as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
| Secondary | Objective response rate (ORR) | Up to 2 years | Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Patients who respond to treatment and die without progressive disease (PD) (including death from study disease), duration of response will be censored at the date of the last objective progression-free disease assessment. For responding patients not known to have died as of the data cut-off date and who do not have PD, duration of response will be censored at the last progression-free assessment date. For responding patients who receive subsequent anticancer therapy (after discontinuation from all study treatment excluding PCI) prior to disease progression, duration of response will be censored at the date of last progression-free assessment prior to the initiation of post discontinuation anticancer therapy. |
| Secondary | Duration of overall response | Up to 2 years | Measured by RECIST v1.1. |
| Secondary | Incidence of safety and adverse events | Up to 2 years | Assessed by CTCAE version 5.0. |
| Secondary | Progression-free survival (PFS) | Up to 2 years | As defined by RECIST v1.1. |
| Secondary | Overall survival (OS) | Time from the date of study enrollment to the date of death from any cause, assessed up to 2 years | OS which is defined as the time from the date of study enrollment to the date of death from any cause. For patients who are still alive as of the data cutoff date, OS time will be censored on the date of the patient's last contact (last contact for patients in post discontinuation is last known alive date in mortality status). |
| Other | Cmax of LB-100 | Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)] | Plasma sampling for pharmacokinetic (PK) measurements of LB-100 will be performed . Blood samples will be collected to determine the Cmax of LB-100. |
| Other | Cmax of endothall | Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)] | Plasma sampling for pharmacokinetic (PK) measurements of endothall, the metabolite of LB-100, will be performed . Blood samples will be collected to determine the Cmax of endothall. |
| Other | Tmax of LB-100 | Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)] | Plasma sampling for pharmacokinetic (PK) measurements of LB-100 will be performed . Blood samples will be collected to determine the Tmax of LB-100. |
| Other | Tmax of endothall | Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)] | Plasma sampling for pharmacokinetic (PK) measurements of endothall, the metabolite of LB-100, will be performed . Blood samples will be collected to determine the Tmax of endothall. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04560972
GET https://conductscience.org/api/trials/v1/NCT04560972/registered