Clinical Trials in Italy / NCT07361510
Recruiting
Phase 3
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)
NCT07361510 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Non-Small Cell Lung Cancer (NSCLC)
Investigational drug(s) / intervention(s)
Pumitamig: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
Study summary
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%.
Eligibility
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.
Primary outcome measure(s)
- Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 — Up to approximately 3 years
- Overall survival (OS) — Up to approximately 5 years
Trial sites (284)
| Facility | City | Region | Status |
|---|---|---|---|
| Southern Cancer Center Pc | Daphne | Alabama | Recruiting |
| Mohtaseb Cancer Center & Blood Disorders | Bullhead City | Arizona | Recruiting |
| Palo Verde Hematology Oncology | Glendale | Arizona | Recruiting |
| Beverly Hills Cancer Center | Beverly Hills | California | Recruiting |
| Orange Coast Memorial Medical Center | Fountain Valley | California | Recruiting |
| Local Institution - 0027 | Los Alamitos | California | Not Yet Recruiting |
| Local Institution - 0422 | Los Angeles | California | Not Yet Recruiting |
| Pacific Cancer Care | Monterey | California | Recruiting |
| Local Institution - 0403 | Oakland | California | Not Yet Recruiting |
| Local Institution - 0208 | Pleasant Hill | California | Not Yet Recruiting |
| BASS Cancer Center | Walnut Creek | California | Recruiting |
| Local Institution - 0340 | Lakewood | Colorado | Not Yet Recruiting |
| Clermont Oncology Center | Clermont | Florida | Recruiting |
| Advanced Research | Coral Springs | Florida | Recruiting |
| BRP- Hialeah Hospital | Hialeah | Florida | Recruiting |
| Florida Clinical Trials Group | Tamarac | Florida | Recruiting |
| University Cancer & Blood Center, LLC | Athens | Georgia | Recruiting |
| Local Institution - 0412 | Augusta | Georgia | Not Yet Recruiting |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital | Marietta | Georgia | Recruiting |
| Local Institution - 0423 | Urbana | Illinois | Not Yet Recruiting |
| Northwest Cancer Centers, P.C. | Dyer | Indiana | Recruiting |
| Missouri Cancer Associates | Columbia | Missouri | Recruiting |
| Local Institution - 0224 | Laurelton | New York | Not Yet Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| Optum Medical Care, PC | Westbury | New York | Recruiting |
| Novant Health Pharmacy Oncology Specialists | Winston-Salem | North Carolina | Recruiting |
| Local Institution - 0383 | Cincinnati | Ohio | Not Yet Recruiting |
| Local Institution - 0418 | Oklahoma City | Oklahoma | Not Yet Recruiting |
| Lancaster General Hospital | Lancaster | Pennsylvania | Recruiting |
| Local Institution - 0028 | Pittsburgh | Pennsylvania | Not Yet Recruiting |
| WellSpan Oncology Research | York | Pennsylvania | Recruiting |
| University Of Texas Medical Branch At Galveston | Galveston | Texas | Recruiting |
| Kelsey-Seybold Clinic Main Campus | Houston | Texas | Recruiting |
| Texas Oncology - San Antonio | San Antonio | Texas | Recruiting |
| Local Institution - 0381 | San Antonio | Texas | Not Yet Recruiting |
| Local Institution - 0337 | Richmond | Virginia | Not Yet Recruiting |
| Shenandoah Oncology, P.C. | Winchester | Virginia | Recruiting |
| Local Institution - 0384 | Spokane | Washington | Not Yet Recruiting |
| Charleston Area Medical Center (CAMC) | Charleston | West Virginia | Recruiting |
| HSHS St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | Recruiting |
+ 244 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More Bristol-Myers Squibb trials in Italy
Other trials for the same condition
Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)
Active, not recruiting
GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07361510 on ClinicalTrials.gov ↗ ← All trials in Italy