Non-small Cell Lung Cancer (NSCLC)
Conditions
Keywords
Pumitamig, Locally advanced, Unresectable, Stage 3 Non-small Cell Lung Cancer (NSCLC), CA2660001
Brief summary
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
Interventions
DRUGPumitamig
Specified dose on specified days
DRUGDurvalumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
BioNTech SE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) by blinded independent central review (BICR) (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) | Up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | Up to approximately 9 years |
| PFS by investigator (per RECIST v1.1) | Up to 3 years |
| Objective response (OR) by BICR (per RECIST v1.1) | Up to 3 years |
| Disease control rate (DCR) by BICR (per RECIST v1.1) | Up to 3 years |
| Duration of response (DOR) by BICR (per RECIST v1.1) | Up to 3 years |
| Time to Response (TTR) by BICR (per RECIST v1.1) | Up to 3 years |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Mexico, Netherlands, Poland, Puerto Rico, Romania, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed