Last Update: Nov 13, 2026
A Phase I, Open-label, Multi-center Study of TRB191 in Patients With Extensive Stage Small Cell Lung Cancer
ClinicalTrials.gov Identifier:
Novartis Reference Number:CTRB191A12101
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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). 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.

Extensive-stage Small Cell Lung Cancer
Phase1
Recruiting
120
Nov 17, 2026
Jul 30, 2030
All
18 Years - (Adult, Older Adult)

Interventions

Drug

TRB191

Subcutaneous injection of TRB191

Eligibility Criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Novartis Investigative Site

Recruiting

Tel Aviv,6423906,Israel

Worldwide Contacts

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Novartis Pharmaceuticals

Novartis Pharmaceuticals