A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer
Key facts
- Where
- Avellino, Bologna, Genoa, Milan, Monza, Padova és Rome, OlaszországSee the 7 sites
- Phase
- 2. fázis
Where in Olaszország
- AORN San Giuseppe Moscati AvellinoAvellino, OlaszországNo longer taking part
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, OlaszországNo longer taking part
- IRCCS Ospedale Policlinico San MartinoGenoa, OlaszországNo longer taking part
- European Institute Of Oncology S.r.l.Milan, OlaszországNo longer taking part
- Fondazione IRCCS San Gerardo dei TintoriMonza, OlaszországNo longer taking part
- Istituto Oncologico VenetoPadova, OlaszországNo longer taking part
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- F. Hoffmann-La Roche AG
- Trial code
- EU 2023-505211-21-00
- Record updated
- 2026. július 10.
- Original description
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)Read full original descriptionShow less
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
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)
Inclusion: 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.
Exclusion: History of leptomeningeal disease; Active or history of autoimmune disease or immune deficiency; 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; 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).