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RecruitingPhase 3

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)

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.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares pumitamig with durvalumab after chemotherapy and radiation given at the same time. It is for people with stage III non-small cell lung cancer that cannot be removed by surgery.

A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage III non-small cell lung cancer confirmed by a tissue or cell test, which cannot be removed by surgery.
  • Have had at least 2 cycles of platinum-based chemotherapy given with radiation, with a total radiation dose of at least 54 Gy.
  • Have cancer that has not gotten worse after chemotherapy and radiation.
  • Be fully active or able to do light work, with limits only on hard physical activity (ECOG score of 0 or 1).

Who can't join

  • For non-squamous cancer, a type of lung cancer: have documented EGFR or ALK gene changes.
  • Have an active autoimmune disease, in which the body's defenses attack healthy tissue.
  • Have serious heart or blood vessel problems, such as uncontrolled high blood pressure despite treatment, heart failure, abnormal rhythms in the heart's lower chambers, or active heart artery disease within the past 6 months.
  • Have had major blood clots or major bleeding within the past 6 months, or have a high risk of bleeding in the lungs.
  • Have had serious lung disease within the past 6 months; past lung scarring or inflammation needing steroid treatment throughout the body; or current or suspected lung scarring or inflammation.
  • Have had any other cancer treatment for stage III disease besides chemotherapy and radiation given at the same time.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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. Exclusion 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.

Study sites (38)

AL

CO

DE

FL

GA

IL

IN

KY

MA

MI

  • Karmanos Cancer Institute · Detroit, MI 48201Khalil Choucair, Site 0419 · Study contactMore trials in Detroit

MN

MO

NC

NY

OH

OR

TN

TX

VA