About this trial
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Pumitamig
DrugSpecified dose on specified days
Durvalumab
DrugSpecified dose on specified days
Treatment groups
Trial outcomes
Primary outcomes
Progression-free survival (PFS) by blinded independent central review (BICR) (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)
Secondary outcomes
Overall survival (OS)
PFS by investigator (per RECIST v1.1)
Objective response (OR) by BICR (per RECIST v1.1)
Disease control rate (DCR) by BICR (per RECIST v1.1)
Sponsors and contacts
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Bristol-Myers Squibb
Lead sponsor
BioNTech SE
Collaborator