A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Pumitamig

    Drug

    Specified dose on specified days

  • Durvalumab

    Drug

    Specified dose on specified days

Treatment groups

850 Participants
are divided into 2 treatment groups
Group A: Arm AExperimental treatment 1 intervention
Group B: Arm BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS) by blinded independent central review (BICR) (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)

Time frame
Up to 3 years

Secondary outcomes

1

Overall survival (OS)

Time frame
Up to approximately 9 years
2

PFS by investigator (per RECIST v1.1)

Time frame
Up to 3 years
3

Objective response (OR) by BICR (per RECIST v1.1)

Time frame
Up to 3 years
4

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

Time frame
Up to 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