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Not yet recruitingPhase 2

A Study to Assess The Safety and Tolerability of Pumitamig-Based Therapy Administered Before Surgery in Participants With Early-Stage Non-Small Cell Lung Cancer (ROSETTA Lung-220)

ROSETTA Lung-220: A Phase 2, Open-Label, Multicenter, Multi-Arm Platform Study Evaluating Pumitamig and Other Novel Neoadjuvant Regimens in Participants With Resectable, Early-Stage (IIA to IIIB) Non-Small Cell Lung Cancer

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 tests pumitamig-based treatment and other study drugs before surgery for early-stage non-small cell lung cancer. It looks at safety, how well people handle treatment, and whether surgery can be done afterward. It is for people with newly diagnosed, untreated cancer that can be removed by surgery.

The purpose of this study is to assess the safety, tolerability, and surgical feasibility of preoperative Pumitamig-based therapy and other molecules in resectable, Early-Stage Non-Small Cell Lung Cancer

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

Eligibility

Who can join

  • Have newly diagnosed non-small cell lung cancer confirmed by a tissue test, with no past treatment.
  • Have stage IIA to IIIB (N2) cancer that can be removed by surgery.
  • Be fully active or able to do light work, even if hard physical activity is limited.
  • Have a PD-L1 level that can be measured. PD-L1 is a protein linked to how the immune system responds to cancer.

Who can't join

  • Cancer cannot be removed by surgery, has spread to lymph nodes classified as N3, or may have spread to distant parts of the body.
  • Have a known, active autoimmune disease, in which the immune system attacks the body.
  • Have serious heart or blood vessel problems, such as high blood pressure not controlled by treatment, heart failure, active heart artery disease within the past 6 months, abnormal rhythms in the heart’s lower chambers, or major blood clots.
  • Have serious lung disease within the past 6 months; past lung inflammation or scarring that needed steroid treatment throughout the body; or current or suspected lung inflammation or scarring.
  • Have a high risk of bleeding or past major bleeding, including bleeding in the stomach or intestines or a stroke caused by bleeding.
  • Have an abnormal tunnel between body parts, a hole in the stomach or intestines, or a pocket of infection inside the belly.
  • Have had whole-body cancer drugs, radiation, or experimental treatment for this lung cancer, or cannot safely have surgery meant to cure the cancer or the study’s chemotherapy.
  • Other study rules also apply.

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

Official eligibility criteria

Inclusion Criteria * Participants must have newly diagnosed, previously untreated participants with histologically confirmed non-small cell lung cancer (NSCLC) (squamous or non-squamous histology); resectable Stage IIA to IIIB (N2) disease (American Joint Committee on Cancer (AJCC) 9th edition). * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Participants must have an evaluable programmed death-ligand 1 (PD-L1) expression. Exclusion Criteria * Participants must not have unresectable disease, N3 nodal involvement, or any evidence of distant metastatic disease (M1) at baseline assessment (suspected or confirmed). * Participants must not have active, known autoimmune disease. * Participants must not have 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. * 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 who have current or suspected ILD or pneumonitis. * Participants must not have significant risk of bleeding or history of major hemorrhagic events (including gastrointestinal (GI) hemorrhage or hemorrhagic stroke). * Participants must not have GI or non-GI fistula, GI perforation, or intra-abdominal abscess. * Participants must not have prior systemic anticancer therapy, radiotherapy, or investigational therapy for NSCLC or contraindication to curative-intent surgery or study-specified chemotherapy. * Other protocol-defined Inclusion/Exclusion criteria apply.

Study sites (9)

CA

FL

IL

MA

OR

PA

TN

TX