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%

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523586-18-00

Enrollment

Registered

2026-05-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Brief summary

Progression-free survival (PFS) assessed by BICR, to see if pumitamig works better than pembrolizumab by evaluating how long it takes before the cancer starts growing again by radiographic imaging techniques, Overall Survival (OS), to assess if people live longer when they take pumitamig compared to pembrolizumab

Detailed description

overall response of pumitamig versus pembrolizumab, how safe each medicine is, how well participants tolerate the medicines

Interventions

DRUGBNT327 20 mg ml

DRUGBNT327 50 mg ml

DRUGPEMBROLIZUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) assessed by BICR, to see if pumitamig works better than pembrolizumab by evaluating how long it takes before the cancer starts growing again by radiographic imaging techniques, Overall Survival (OS), to assess if people live longer when they take pumitamig compared to pembrolizumab	—

Secondary

Measure	Time frame
overall response of pumitamig versus pembrolizumab, how safe each medicine is, how well participants tolerate the medicines	—

Outcome results

None listed

Source: EU CTIS · Data processed: May 19, 2026