A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)
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, Durvalumab.
- 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 +27
- 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-201: A Randomized, Multicenter, Open-label Phase 3 Study of Pumitamig Monotherapy Compared to Durvalumab in Participants With Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy.
Overview
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
Interventions
- Drug Pumitamig
Specified dose on specified days - Drug Durvalumab
Specified dose on specified days
Primary outcome measures
- Progression-free survival (PFS) by blinded independent central review (BICR) (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) [Time frame: Up to 3 years]
Secondary outcome measures (6)
- Overall survival (OS) [Time frame: Up to approximately 9 years]
- PFS by investigator (per RECIST v1.1) [Time frame: Up to 3 years]
- Objective response (OR) by BICR (per RECIST v1.1) [Time frame: Up to 3 years]
- Disease control rate (DCR) by BICR (per RECIST v1.1) [Time frame: Up to 3 years]
- Duration of response (DOR) by BICR (per RECIST v1.1) [Time frame: Up to 3 years]
- Time to Response (TTR) by BICR (per RECIST v1.1) [Time frame: Up to 3 years]
Eligibility criteria
Inclusion criteria
- Participants must have a histologically- or cytologically-confirmed diagnoses of non-small cell lung cancer (NSCLC) with unresectable Stage III disease.
- Participants must have received at least 2 cycles of platinum-based concurrent chemoradiotherapy (a total dose of radiation of at least 54 Gy).
- Participants must have no progressive disease (PD) following treatment with concurrent chemoradiotherapy (CCRT).
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
Exclusion criteria
- Participants with non-squamous histology must not have documented Epidermal Growth Factor Receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements.
- Participants must not have an active autoimmune disease.
- Participants must not have significant cardiovascular impairment such as uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, major thrombotic or embolic events or major hemorrhagic events within 6 months prior to randomization, or significant risk of pulmonary hemorrhage.
- Participants must not have advanced/clinically significant lung disease (within 6 months prior to randomization) or history of interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids (≥ Grade 2), or current or suspected ILD or pneumonitis.
- Participants must not have any prior anticancer therapy (outside of CCRT) for locally advanced Stage III 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
- Open label
- Primary purpose
- Treatment
Study locations
United States · 38 centers
- Southern Cancer Center Pc — Daphne
- Local Institution - 0780 — Chandler
- Intermountain Health Cancer Center Lutheran Hospital — Golden
- Medical Oncology Hematology Consultants, PA — Newark
- Local Institution - 0711 — Ocala
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital — Marietta
- Local Institution - 0398 — Chicago
- Local Institution - 0850 — Evanston
- … and 30 more centers
China · 26 centers
Center list to be confirmed — check the primary protocol.
Japan · 14 centers
Center list to be confirmed — check the primary protocol.
Germany · 13 centers
Center list to be confirmed — check the primary protocol.
India · 12 centers
Center list to be confirmed — check the primary protocol.
France · 11 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 11 centers
Center list to be confirmed — check the primary protocol.
Spain · 9 centers
Center list to be confirmed — check the primary protocol.
Argentina · 8 centers
- Local Institution - 0093 — Buenas Aires
- Local Institution - 0082 — Mar del Plata
- Hospital Privado Universitario de Córdoba — Córdoba
- Local Institution - 0097 — Rosario
- Instituto Medico Especializado Alexander Fleming — Buenos Aires
- Local Institution - 0078 — Buenos Aires
- Local Institution - 0761 — Buenos Aires
- Instituto de Investigaciones Clínicas Córdoba S.A. — Córdoba
Italy · 8 centers
Center list to be confirmed — check the primary protocol.
Romania · 8 centers
Center list to be confirmed — check the primary protocol.
Australia · 7 centers
- Gosford Hospital — Gosford
- Nepean Hospital — Penrith
- Lyell McEwin Hospital — Elizabeth Vale
- Grampians Health — Ballarat Central
- Local Institution - 0458 — Epping
- Joondalup Health Campus — Joondalup
- Local Institution - 0451 — Wentworthville
Belgium · 7 centers
- Local Institution - 0122 — Anderlecht
- Local Institution - 0111 — Charleroi
- Ziekenhuis Oost-Limburg, Campus St.-Jan — Genk
- UZ Gent — Ghent
- VITAZ — Sint-Niklaas
- UZ Leuven — Leuven
- Algemeen Ziekenhuis klina — Brasschaat
Brazil · 6 centers
- Local Institution - 0615 — Teresina
- Liga Norte Riograndense Contra o Câncer — Natal
- Local Institution - 0619 — Porto Alegre
- Fundação Pio XII - Hospital de Câncer de Barretos — Barretos
- Fundação Faculdade Regional de Medicina de São José do Rio Preto — São José do Rio Preto
- Local Institution - 0912 — São Paulo
Greece · 6 centers
Center list to be confirmed — check the primary protocol.
Mexico · 6 centers
Center list to be confirmed — check the primary protocol.
Netherlands · 6 centers
Center list to be confirmed — check the primary protocol.
South Korea · 6 centers
Center list to be confirmed — check the primary protocol.
Turkey (Türkiye) · 6 centers
Center list to be confirmed — check the primary protocol.
Bulgaria · 5 centers
- Local Institution - 0736 — Haskovo
- Complex Oncology Center - Ruse EOOD — Rousse
- Local Institution - 0826 — Sofia
- Local Institution - 0732 — Sofia
- Diagnostic and Consultative Center Convex — Sofia
Chile · 5 centers
- Local Institution - 0910 — Antofagasta
- Local Institution - 0855 — Las Condes
- Local Institution - 0478 — Santiago
- … and 2 more centers
Hungary · 5 centers
Center list to be confirmed — check the primary protocol.
Poland · 4 centers
Center list to be confirmed — check the primary protocol.
Switzerland · 4 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 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
- Universitätsklinik Innsbruck — Innsbruck
- Local Institution - 0192 — Linz
- Local Institution - 0207 — Vienna
Canada · 3 centers
- The Ottawa Hospital - General Campus — Ottawa
- St. Marys Hospital Center — Montreal
- IUCPQ — Québec
Hong Kong · 3 centers
Center list to be confirmed — check the primary protocol.
Ireland · 3 centers
Center list to be confirmed — check the primary protocol.
Sweden · 3 centers
Center list to be confirmed — check the primary protocol.
Singapore · 2 centers
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07361497 · CA266-0001