NIPH Clinical Trials Search

A Study of Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants with Unresectable Stage III NSCLC

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Non-small Cell Lung Cancer (NSCLC)
Date of first enrollment	15/05/2026
Target sample size	50
Countries of recruitment	Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,Chile,Japan,China,Japan,France,Japan,Germany,Japan,Greece,Japan,Hong Kong,Japan,Hungary,Japan,India,Japan,Ireland,Japan,Italy,Japan,Mexico,Japan,Netherlands,Japan,Poland,Japan,Romania,Japan,Singapore,Japan,South Korea,Japan,Spain,Japan,Sweden,Japan,Switzerland,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan
Study type	Interventional
Intervention(s)	Drug: Pumitamig Drug: Durvalumab

Outcome(s)

Primary Outcome	Progression-free survival (PFS) by blinded independent central review (BICR) (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)
Secondary Outcome	- Overall survival (OS) - PFS by investigator (per RECIST v1.1) - OR by BICR (per RECIST v1.1) - DCR by BICR (per RECIST v1.1) - DOR by BICR (per RECIST v1.1) - TTR by BICR (per RECIST v1.1)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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/Exclusion criteria apply.