Trial · NCT07908667
A Study of TRB191 in Patients With Extensive-stage Small Cell Lung Cancer
NCT07908667, Phase 1, Not yet recruiting, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of TRB191 in Patients With Extensive-stage Small Cell Lung Cancer. Trials, record NCT07908667. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07908667
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of TRB191 in Patients With Extensive-stage Small Cell Lung Cancer
- NCT number
- NCT07908667
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 120 participants, estimated
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Interventions
- TRB191
- First posted
- 2026-11-02
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to approximately 24 months | Number of participants with AEs and SAEs, including changes in laboratory values, vital signs and echocardiograms (ECGs) qualifying and reported as AEs. |
| Primary | Incidence of Dose Limiting Toxicities (DLTs) | 21 days | Number of participants with DLTs. A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher, unless clearly and incontrovertibly assessed as due to underlying disease, disease progression, or intercurrent illness, that occurs within the first 21 days of treatment with TRB191. Other clinically significant toxicities may be considered DLTs, even if not CTCAE grade 3 or higher. |
| Primary | Frequency of dose interruptions and reductions | Up to approximately 24 months | Number of participants with dose adjustments (interruptions and reductions as a measure of tolerability. |
| Primary | Dose intensity | Up to approximately 24 months | Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure. |
| Secondary | Maximum serum concentration (Cmax) of TRB191 | From pre-dose up to 120 or 240 hours post-dose | Pharmacokinetic (PK) parameters based on serum concentrations of TRB191. Cmax will be determined using non-compartmental method(s). |
| Secondary | Time to reach maximum serum concentration (Tmax) of TRB191 | From pre-dose up to 120 or 240 hours post-dose | PK parameters based on serum concentrations of TRB191. Tmax will be determined using non-compartmental method(s). |
| Secondary | Arean under the serum concentration-time curve (AUC) of TRB191 | From pre-dose up to 120 or 240 hours post-dose | PK parameters based on serum concentrations of TRB191. AUC will be determined using non-compartmental method(s). |
| Secondary | Number of participants with anti-drug antibodies (ADA) | From baseline (pre-dose) up to approximately 24 months | Number of participants with anti-TRB191 antibodies during treatment. |
| Secondary | Overall Response Rate (ORR) per RECIST v1.1 | Up to approximately 24 months | ORR is defined as the proportion of patients with a best overall response (BOR) of Complete response (CR) or Partial response (PR) as per local review and according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1). |
| Secondary | Disease Control Rate (DCR) per RECIST v1.1 | Up to approximately 24 months | DCR is defined as the proportion of patients with a BOR of CR, PR, or stable disease as per local review and according to RECIST v1.1. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 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/NCT07908667
GET https://conductscience.org/api/trials/v1/NCT07908667/registered