Health Trials

A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)

ConditionNon-Small Cell Lung Cancer (NSCLC)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have a histologically or cytologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) (squamous and nonsquamous) with Stage IIIB/IIIC or Stage IV disease.

Participants must have a programmed death ligand-1 (PD-L1) expression ≥ 50%.

Participants must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Participants must have no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.

Disqualifiers

Participants must not have any documented actionable genomic alteration (AGA) for which first-line (1L) approved therapies are indicated.

Participants must not have any symptomatic untreated central nervous system (CNS) metastases, leptomeningeal metastases (carcinomatous meningitis) or spinal cord compression.

Participants must not have any significant cardiovascular impairment as evidenced by uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, or major thrombotic or embolic events or major hemorrhagic events (within 6 months prior to randomization), or significant risk of pulmonary hemorrhage.

Participants must not an active autoimmune disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pumitamig

    Drug

    Specified dose on specified days

  • Pembrolizumab

    Drug

    Specified dose on specified days

Treatment groups

750 Participants
are divided into 2 treatment groups
Group A: Arm A: PumitamigExperimental treatment 1 intervention
Group B: Arm B: PembrolizumabActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Time frame
Up to approximately 3 years
2

Overall survival (OS)

Time frame
Up to approximately 5 years

Secondary outcomes

1

PFS by investigator according to RECIST v1.1

Time frame
Up to approximately 3 years
2

Objective Response (OR) by BICR according to RECIST v1.1

Time frame
Up to approximately 3 years
3

Duration of response (DOR) by BICR according to RECIST v1.1

Time frame
Up to approximately 3 years
4

Disease control rate (DCR) by BICR according to RECIST v1.1

Time frame
Up to approximately 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

BioNTech SE

Collaborator

Source ClinicalTrials.gov
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