A Study to Assess The Safety and Tolerability of Pumitamig-Based Therapy Administered Before Surgery in Participants With Early-Stage Non-Small Cell Lung Cancer (ROSETTA Lung-220)
First line of the email MUST contain NCT # and Site #.
CONTACT
Lead
Bristol-Myers Squibb
With
BioNTech SE
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants must have newly diagnosed, previously untreated participants with histologically confirmed non-small cell lung cancer (NSCLC) (squamous or non-squamous histology); resectable Stage IIA to IIIB (N2) disease (American Joint Committee on Cancer (AJCC) 9th edition).
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Participants must have an evaluable programmed death-ligand 1 (PD-L1) expression.
You may not be if
Participants must not have unresectable disease, N3 nodal involvement, or any evidence of distant metastatic disease (M1) at baseline assessment (suspected or confirmed).
Participants must not have active, known autoimmune disease.
Participants must not have 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.
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 who have current or suspected ILD or pneumonitis.
Participants must not have significant risk of bleeding or history of major hemorrhagic events (including gastrointestinal (GI) hemorrhage or hemorrhagic stroke).
Participants must not have GI or non-GI fistula, GI perforation, or intra-abdominal abscess.
Participants must not have prior systemic anticancer therapy, radiotherapy, or investigational therapy for NSCLC or contraindication to curative-intent surgery or study-specified chemotherapy.
Clareo Health | A Study to Assess The Safety and Tolerability of Pumitamig-Based Therapy Administered Before Surgery in Participants With Early-Stage Non-Small Cell Lung Cancer (ROSETTA Lung-220)
