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%

In order to be eligible to participate in this study, a patient must meet all of the following criteria:
– Histologically or cytologically confirmed diagnosis of NSCLC (squamous and non-squamous) with Stage IIIB/IIIC or Stage IV disease per the UICC/AJCC Staging System 9th edition.
– PD-L1 expression ≥ 50%, as determined by Sponsor pre-approved local PD-L1 IHC assays (VENTANA PD-L1 [SP263] assay, Agilent PD-L1 IHC 22C3 pharmDx, or Agilent PD-L1 IHC 28-8 pharmDx) or central test.
– Tumor tissue (fresh or archival if obtained within 6 months prior to signing IC) must be submitted.
– Measurable disease as defined by RECIST v1.1 with at least 1 measurable extracranial lesion.
– No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
Note: Prior chemoradiation for locally advanced disease or chemotherapy as neoadjuvant or adjuvant therapy is permitted if disease progression occurred ≥6 months after the last dose. Prior immunotherapy as neoadjuvant and/or adjuvant therapy or as part of CCRT is permitted if disease progression occurred ≥12 months after the last dose.
– ECOG Performance Status 0-1

A potential patient who meets any of the following criteria will be excluded from participation in this
study:
– Tumors exhibiting mixed histologies including small cell components and sarcomatoid components.
– Any documented AGA for which 1L approved therapies are indicated. Testing should be performed as part of clinical practice and in accordance with local Health Authority regulations.
– Symptomatic untreated CNS metastases, leptomeningeal metastases (carcinomatous meningitis) or spinal cord compression.
– Significant cardiovascular impairment as evidenced by uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease, ventricular arrhythmias, or major thrombotic or embolic events.
– Active autoimmune disease. Note: Participants with Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll.
– Advanced/clinically significant lung disease (within 6 months prior to randomization) or history of ILD or pneumonitis requiring treatment with systemic steroids (≥ Grade 2), or who have current or suspected ILD or pneumonitis.
– Have a significant risk of pulmonary hemorrhage: tumors with clear radiographic evidence of major blood vessel invasion, invasion of major airways or vital organs or evidence of major cavitation, or clinically significant hemoptysis (≥ 1 teaspoon/5 mL) within 4 weeks prior to randomization.
– Significant risk of bleeding or history of major hemorrhagic events (including GI hemorrhage or hemorrhagic stroke) within 6 months prior to randomization
– GI or non-gastrointestinal fistula, GI perforation, or intra-abdominal abscess (within 6 months prior to randomization)
– Serious non-healing wound, skin ulcer, or non-healing bone fracture (within 4 weeks prior to randomization)
– Urine protein by dipstick ≥2+ and 24-h urine protein ≥ 1g/24 hours
– Prior organ allograft or allogeneic bone marrow transplantation