Extensive-stage Small Cell Lung CancerPhase 1NCT07908667
A Study of TRB191 in Patients With Extensive-stage Small Cell Lung Cancer
A Phase 1 study testing TRB191 in people with Extensive-stage Small Cell Lung Cancer, run by Novartis Pharmaceuticals.
Trial summary
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity (IG) and preliminary anti-tumor activity and to determine a recommended dose (RD) of TRB191 in patients with extensive-stage small cell lung cancer (ES-SCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small Cell Lung Cancer
- What is being tested?
- TRB191
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 17 Nov 2026to 6 Aug 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Histologically or cytologically confirmed and documented ES-SCLC
- Dose escalation: Patients with ES-SCLC and disease progression after one or more chemotherapy regimens (with or without PD-L1 inhibitor) according to the local standard of care (SOC). Prior treatment with a DLL3-targeted therapy is allowed, except in cohorts designed to evaluate TRB191 in patients who are naïve to prior DLL3-targeted therapy
- Dose expansion: Patients with ES-SCLC and disease progression after one or more chemotherapy regimens (with or without PD-L1 inhibitor), according to the local SOC. Patients must have received prior treatment with tarlatamab
Who cannot join
- Patients with inadequate bone marrow function and/or organ functions with out-of-range laboratory values
- Impaired cardiac function or clinically significant cardiac disease
- Presence of symptomatic central nervous system (CNS) metastases or CNS metastases requiring local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry
- Treatment with anti-cancer therapies prior to the first dose of study treatment within the stated timeframes
- Pregnant or nursing woman, and women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
About this study
Official title: A Phase I, Open-label, Multi-center Study of TRB191 in Patients With Extensive Stage Small Cell Lung Cancer
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity (IG) and preliminary anti-tumor activity and to determine a recommended dose (RD) of TRB191 in patients with extensive-stage small cell lung cancer (ES-SCLC).
Read the detailed description
This is a phase I, open-label, multi-center, first-in-human (FIH) study of TRB191 in adult patients with ES-SCLC. The study is comprised of a dose escalation part followed by a dose expansion part in second-line and beyond (2L+) ES-SCLC patients.
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Being tested
- TRB191
- Keywords
- Small cell lung cancer (SCLC), Extensive-stage small cell lung cancer (ES-SCLC), TRB191, Biologics
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRB191Drug
Subcutaneous injection of TRB191
| Study group | Role | What they receive |
|---|---|---|
| TRB191 single agent | Experimental | Treatment with TRB191 single agent in patients with extensive-stage small cell lung cancer. Receives: Drug: TRB191 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs, including changes in laboratory values, vital signs and echocardiograms (ECGs) qualifying and reported as AEs.
Measured: Up to approximately 24 months
Incidence of Dose Limiting Toxicities (DLTs)
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.
Measured: 21 days
Frequency of dose interruptions and reductions
Number of participants with dose adjustments (interruptions and reductions as a measure of tolerability.
Measured: Up to approximately 24 months
Dose intensity
Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure.
Measured: Up to approximately 24 months
Secondary outcomes (8)
Maximum serum concentration (Cmax) of TRB191
Pharmacokinetic (PK) parameters based on serum concentrations of TRB191. Cmax will be determined using non-compartmental method(s).
Measured: From pre-dose up to 120 or 240 hours post-dose
Time to reach maximum serum concentration (Tmax) of TRB191
PK parameters based on serum concentrations of TRB191. Tmax will be determined using non-compartmental method(s).
Measured: From pre-dose up to 120 or 240 hours post-dose
Arean under the serum concentration-time curve (AUC) of TRB191
PK parameters based on serum concentrations of TRB191. AUC will be determined using non-compartmental method(s).
Measured: From pre-dose up to 120 or 240 hours post-dose
Number of participants with anti-drug antibodies (ADA)
Number of participants with anti-TRB191 antibodies during treatment.
Measured: From baseline (pre-dose) up to approximately 24 months
Overall Response Rate (ORR) per RECIST v1.1
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).
Measured: Up to approximately 24 months
Disease Control Rate (DCR) per RECIST v1.1
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.
Measured: Up to approximately 24 months
Duration of Response (DOR) per RECIST v1.1
DOR is the time between the first documented response (CR or PR) and the date of progression as per local review and according to RECIST v 1.1, or death due to any cause.
Measured: Up to approximately 24 months
Progression-Free Survival (PFS) per RECIST v1.1
PFS is defined as the time from the date of start of treatment to the date of the first documented progression as per local review and according to RECIST v1.1 or death due to any cause.
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start17 Nov 2026 (estimated)
- Primary completion6 Aug 2030 (estimated)
- Study completion6 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908667
- Sponsor's protocol ID
- CTRB191A12101
- Other IDs
- 2026-526463-37
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Multi-center Study of TRB191 in Patients With Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07908667
- Acronym / sponsor ID
- CTRB191A12101
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Keywords
- Small cell lung cancer (SCLC), Extensive-stage small cell lung cancer (ES-SCLC), TRB191, Biologics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2026 (estimated)
- Primary completion
- 6 Aug 2030 (estimated)
- Study completion
- 6 Aug 2030 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity (IG) and preliminary anti-tumor activity and to determine a recommended dose (RD) of TRB191 in patients with extensive-stage small cell lung cancer (ES-SCLC).
Detailed description
This is a phase I, open-label, multi-center, first-in-human (FIH) study of TRB191 in adult patients with ES-SCLC. The study is comprised of a dose escalation part followed by a dose expansion part in second-line and beyond (2L+) ES-SCLC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRB191 single agent | Experimental | Drug: TRB191Treatment with TRB191 single agent in patients with extensive-stage small cell lung cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Histologically or cytologically confirmed and documented ES-SCLC
- Dose escalation: Patients with ES-SCLC and disease progression after one or more chemotherapy regimens (with or without PD-L1 inhibitor) according to the local standard of care (SOC). Prior treatment with a DLL3-targeted therapy is allowed, except in cohorts designed to evaluate TRB191 in patients who are naïve to prior DLL3-targeted therapy
- Dose expansion: Patients with ES-SCLC and disease progression after one or more chemotherapy regimens (with or without PD-L1 inhibitor), according to the local SOC. Patients must have received prior treatment with tarlatamab
Key exclusion criteria (6 listed)
- Patients with inadequate bone marrow function and/or organ functions with out-of-range laboratory values
- Impaired cardiac function or clinically significant cardiac disease
- Presence of symptomatic central nervous system (CNS) metastases or CNS metastases requiring local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry
- Treatment with anti-cancer therapies prior to the first dose of study treatment within the stated timeframes
- Pregnant or nursing woman, and women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRB191Subcutaneous injection of TRB191 | Drug | TRB191 single agent |
Primary outcome
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 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.
Incidence of Dose Limiting Toxicities (DLTs)
Time frame: 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.
Frequency of dose interruptions and reductions
Time frame: Up to approximately 24 months
Number of participants with dose adjustments (interruptions and reductions as a measure of tolerability.
Dose intensity
Time frame: Up to approximately 24 months
Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure.
8 secondary outcomes
Maximum serum concentration (Cmax) of TRB191
Time frame: From pre-dose up to 120 or 240 hours post-dose
Time to reach maximum serum concentration (Tmax) of TRB191
Time frame: From pre-dose up to 120 or 240 hours post-dose
Arean under the serum concentration-time curve (AUC) of TRB191
Time frame: From pre-dose up to 120 or 240 hours post-dose
Number of participants with anti-drug antibodies (ADA)
Time frame: From baseline (pre-dose) up to approximately 24 months
Overall Response Rate (ORR) per RECIST v1.1
Time frame: Up to approximately 24 months
Disease Control Rate (DCR) per RECIST v1.1
Time frame: Up to approximately 24 months
Duration of Response (DOR) per RECIST v1.1
Time frame: Up to approximately 24 months
Progression-Free Survival (PFS) per RECIST v1.1
Time frame: Up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRB191 in people with Extensive-stage Small Cell Lung Cancer, run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to approximately 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.