ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 study of Pumitamig Monotherapy Compared to Durvalumab in Participants with Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy

Conditions

Unresectable Stage III non-small cell lung cancer without progression

Brief summary

to find out which medicine works better at delaying cancer growth (progression-free survival; PFS by BICR)

Detailed description

To see if participants live longer when taking pumitamig instead of durvalumab (Overall Survival; OS), Measuring how long it takes for the cancer to get worse, as judged by the participant’s doctor (PFS by investigator), Seeing how many participant’s tumors shrink or disappear with each medicine (Objective Response; OR), Seeing how many participants have their cancer stay the same size or shrink (Disease Control Rate; DCR), Measuring how long tumors stay smaller or stable after improving (Duration of Response; DOR), Timing how quickly tumors start to shrink after treatment (Time to Response; TTR), Look at how safe each medicine is and how well participants tolerate them

Related papers

No related papers found yet.

Papers published before 2002-11-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGBNT327 50 mg ml

DRUGDURVALUMAB

DRUGBNT327 20 mg ml

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
to find out which medicine works better at delaying cancer growth (progression-free survival; PFS by BICR)	—

Secondary

Measure	Time frame
To see if participants live longer when taking pumitamig instead of durvalumab (Overall Survival; OS), Measuring how long it takes for the cancer to get worse, as judged by the participant’s doctor (PFS by investigator), Seeing how many participant’s tumors shrink or disappear with each medicine (Objective Response; OR), Seeing how many participants have their cancer stay the same size or shrink (Disease Control Rate; DCR), Measuring how long tumors stay smaller or stable after improving (Duration of Response; DOR), Timing how quickly tumors start to shrink after treatment (Time to Response; TTR), Look at how safe each medicine is and how well participants tolerate them	—

Measure

Time frame

To see if participants live longer when taking pumitamig instead of durvalumab (Overall Survival; OS), Measuring how long it takes for the cancer to get worse, as judged by the participant’s doctor (PFS by investigator), Seeing how many participant’s tumors shrink or disappear with each medicine (Objective Response; OR), Seeing how many participants have their cancer stay the same size or shrink (Disease Control Rate; DCR), Measuring how long tumors stay smaller or stable after improving (Duration of Response; DOR), Timing how quickly tumors start to shrink after treatment (Time to Response; TTR), Look at how safe each medicine is and how well participants tolerate them

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Outcome results

None listed