2023-505211-21-00CompletedPhase 2
A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer
A Phase II, Randomized, Multicenter, Double-Blind, Controlled Study of Tobemstomig Plus Platinum-Based Chemotherapy versus Pembrolizumab Plus Platinum-Based Chemotherapy in Patients with Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Jul 2026
Brief summary (registry, in English)
To evaluate the efficacy of tobemstomig in combination with platinum‑based chemotherapy (Arm A) compared with pembrolizumab plus platinum‑based chemotherapy (Arm B) on the basis of progression‑free survival (PFS) after randomization and objective response rate (ORR)
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 81 (actual)
- First submitted
- 30 Jan 2024
- Start date
- 10 Mar 2023
- Lead sponsor
- F. Hoffmann-La Roche AG
- Diseases
- Lung cancer
- EU CT number
- 2023-505211-21-00
- EudraCT number
- 2022-001440-18
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 81
- 24 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of leptomeningeal disease
- Active or history of autoimmune disease or immune deficiency
Lab values
- NSCLC known to have a mutation in the EGFR gene or an ALK fusion oncogene. Known targetable c-ROS oncogene 1 (ROS1), BRAFV600E or RET proto-oncogene genomic aberrations
Other
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. Untreated or clinically unstable spinal cord compression
- Uncontrolled tumor-related pain. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once a month or more frequently)
Who the study is looking for
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically or cytologically documented locally advanced, unresectable (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC who are not eligible for curative surgery and/or definitive chemoradiotherapy
- No prior systemic treatment for metastatic NSCLC
- Known tumor PD-L1 status
- Confirmed availability of representative tumor specimens
- Adequate hematologic and end-organ function
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| JESSA Ziekenhuis | Hasselt | Belgium | Completed |
| UZ Brussel | Jette | Belgium | Completed |
| UZ Leuven | Leuven | Belgium | Completed |
| A.Z. Sint-Maarten | Mechelen | Belgium | Completed |
| Universitaetsklinikum Essen (AoR) | Essen | Germany | Completed |
| Complexo Hospitalario Universitario A Coruña | A Coruña | Spain | Completed |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Completed |
| Institut Catala D'oncologia | L'Hospitalet de Llobregat | Spain | Completed |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Completed |
| Hospital Universitario Regional de Málaga | Málaga | Spain | Completed |
| Hospital Son Llatzer | Palma | Spain | Completed |
| Besancon University Hospital Center | Besancon Cedex | France | Completed |
| Centre Leon Berard | Lyon | France | Completed |
| Assistance Publique Hopitaux de Paris | Paris | France | Completed |
| Institut De Cancerologie De L Ouest | St Herblain | France | Completed |
| Institut de Cancérologie Strasbourg Europe | Strasbourg | France | Completed |
| Centre Hospitalier Universitaire de Toulouse | Toulouse | France | Completed |
| AORN San Giuseppe Moscati Avellino | Avellino | Italy | Completed |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico | Bologna | Italy | Completed |
| IRCCS Ospedale Policlinico San Martino | Genoa | Italy | Completed |
| European Institute Of Oncology S.r.l. | Milan | Italy | Completed |
| Fondazione IRCCS San Gerardo dei Tintori | Monza | Italy | Completed |
| Istituto Oncologico Veneto | Padova | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.