A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pumitamig, Pembrolizumab.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer (NSCLC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Austria, Belgium +31
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With PD-L1 ≥ 50%.
Overview
The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.
Interventions
- Drug Pumitamig
Specified dose on specified days - Drug Pembrolizumab
Specified dose on specified days
Primary outcome measures
- Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Time frame: Up to approximately 3 years]
- Overall survival (OS) [Time frame: Up to approximately 5 years]
Secondary outcome measures (6)
- PFS by investigator according to RECIST v1.1 [Time frame: Up to approximately 3 years]
- Objective Response (OR) by BICR according to RECIST v1.1 [Time frame: Up to approximately 3 years]
- Duration of response (DOR) by BICR according to RECIST v1.1 [Time frame: Up to approximately 3 years]
- Disease control rate (DCR) by BICR according to RECIST v1.1 [Time frame: Up to approximately 3 years]
- Time to Response (TTR) by BICR according to RECIST v1.1 [Time frame: Up to approximately 3 years]
- Time to definitive deterioration (TTDD) based on the Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) defined as the time from randomization until a definitive clinically meaningful worsening in symptoms or in NSCLC-SAQ total score [Time frame: Up to approximately 3 years]
Eligibility criteria
Inclusion criteria
- Participants must have a histologically or cytologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) (squamous and nonsquamous) with Stage IIIB/IIIC or Stage IV disease.
- Participants must have a programmed death ligand-1 (PD-L1) expression ≥ 50%.
- Participants must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Participants must have no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
Exclusion criteria
- Participants must not have any documented actionable genomic alteration (AGA) for which first-line (1L) approved therapies are indicated.
- Participants must not have any symptomatic untreated central nervous system (CNS) metastases, leptomeningeal metastases (carcinomatous meningitis) or spinal cord compression.
- Participants must not have any significant cardiovascular impairment as evidenced by uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, or major thrombotic or embolic events or major hemorrhagic events (within 6 months prior to randomization), or significant risk of pulmonary hemorrhage.
- Participants must not an active autoimmune disease.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 41 centers
- Southern Cancer Center Pc — Daphne
- Mohtaseb Cancer Center & Blood Disorders — Bullhead City
- Palo Verde Hematology Oncology — Glendale
- Local Institution - 0407 — Anaheim
- Local Institution - 0352 — Beverly Hills
- Orange Coast Memorial Medical Center — Fountain Valley
- Local Institution - 0027 — Los Alamitos
- Local Institution - 0422 — Los Angeles
- … and 33 more centers
China · 24 centers
Center list to be confirmed — check the primary protocol.
Japan · 18 centers
Center list to be confirmed — check the primary protocol.
Germany · 17 centers
Center list to be confirmed — check the primary protocol.
France · 14 centers
Center list to be confirmed — check the primary protocol.
Turkey (Türkiye) · 11 centers
Center list to be confirmed — check the primary protocol.
India · 10 centers
Center list to be confirmed — check the primary protocol.
Romania · 10 centers
Center list to be confirmed — check the primary protocol.
Spain · 9 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 9 centers
Center list to be confirmed — check the primary protocol.
Italy · 8 centers
Center list to be confirmed — check the primary protocol.
Brazil · 7 centers
- Local Institution - 0148 — Fortaleza
- Local Institution - 0066 — Natal/RN
- Local Institution - 0245 — Porto Alegre
- Fundação Pio XII - Hospital de Câncer de Barretos — Barretos
- Local Institution - 0375 — São Paulo
- Local Institution - 0090 — Taubaté
- Centro Paulista de Oncologia Clínica — São Paulo
Argentina · 6 centers
- Local Institution - 0076 — Mar del Plata
- Fundacion Estudios Clinicos — Rosario
- Sanatorio Plaza — Rosario
- Local Institution - 0420 — San Miguel de Tucumán
- Local Institution - 0058 — Buenos Aires
- Local Institution - 0374 — Córdoba
Australia · 6 centers
- Gosford Hospital — Gosford
- Nepean Hospital — Penrith
- Lyell McEwin Hospital — Elizabeth Vale
- Local Institution - 0201 — Epping
- Grampians Health — Mount Waverley
- Joondalup Health Campus — Joondalup
Mexico · 6 centers
Center list to be confirmed — check the primary protocol.
Netherlands · 6 centers
Center list to be confirmed — check the primary protocol.
Canada · 5 centers
- Local Institution - 0411 — Prince George
- Local Institution - 0002 — Halifax
- Local Institution - 0414 — Oshawa
- Local Institution - 0178 — Ottawa
- Local Institution - 0156 — Toronto
Chile · 5 centers
- Local Institution - 0361 — Antofagasta
- Local Institution - 0302 — Las Condes
- Local Institution - 0199 — Santiago
- Local Institution - 0293 — Concepción
- … and 1 more center
Poland · 5 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 5 centers
Center list to be confirmed — check the primary protocol.
Belgium · 4 centers
- ZAS Augustinus — Wilrijk
- Local Institution - 0333 — Auderghem
- Local Institution - 0109 — Leuven
- Algemeen Ziekenhuis klina — Brasschaat
Bulgaria · 4 centers
- Complex Oncology Center - Ruse EOOD — Rousse
- Local Institution - 0326 — Sofia
- Local Institution - 0047 — Sofia
- Local Institution - 0325 — Sofia
Colombia · 4 centers
Center list to be confirmed — check the primary protocol.
Czechia · 4 centers
Center list to be confirmed — check the primary protocol.
Hungary · 4 centers
Center list to be confirmed — check the primary protocol.
South Korea · 4 centers
Center list to be confirmed — check the primary protocol.
Switzerland · 4 centers
Center list to be confirmed — check the primary protocol.
Thailand · 4 centers
Center list to be confirmed — check the primary protocol.
Austria · 3 centers
- Kepler Universitaetsklinikum — Linz
- Local Institution - 0196 — Feldkirch
- Universitätsklinikum St. Pölten — Sankt Pölten
Finland · 3 centers
Center list to be confirmed — check the primary protocol.
Malaysia · 3 centers
Center list to be confirmed — check the primary protocol.
Peru · 3 centers
Center list to be confirmed — check the primary protocol.
Norway · 2 centers
Center list to be confirmed — check the primary protocol.
Portugal · 2 centers
Center list to be confirmed — check the primary protocol.
Singapore · 2 centers
Center list to be confirmed — check the primary protocol.
Sweden · 2 centers
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07361510 · CA266-0002 · 2025-523586-18 · U1111-1326-9286