RightFit
RecruitingPhase 2

A Study To Assess the Safety, Tolerability, and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

A Phase 2, Randomized, Open-label, Study Assessing the Safety, Tolerability and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

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 adding imzokitug to pumitamig and platinum-doublet chemotherapy, a two-drug cancer treatment. It compares safety, side effects, and how well treatment works with and without imzokitug. It is for people with advanced non-small cell lung cancer who have not had whole-body cancer treatment for advanced disease.

The purpose of this study is to assess the safety, tolerability, and efficacy of Imzokitug in combination with Pumitamig and Platinum-Doublet Chemotherapy (PDCT) versus Pumitamig and PDCT as first-line treatment for participants with Locally Advanced or Metastatic 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 non-small cell lung cancer confirmed by a tissue test that is stage IV (has spread far) or has come back and cannot be removed by surgery.
  • Have not had whole-body cancer treatment as the main treatment for advanced cancer.
  • Provide a tumor tissue sample collected within 5 months of signing the study consent form.
  • Be fully active or able to do light work despite limits on hard physical activity.
  • Have cancer that can be measured using the study’s rules.

Who can't join

  • Have a known cancer gene change with an approved targeted drug recommended as the first treatment.
  • Have had cancer treatment that uses the immune system to fight cancer.
  • Have untreated cancer that has spread to the brain or spinal cord.
  • Other study rules may also affect who can join.

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

Official eligibility criteria

Inclusion Criteria * Participants must have histologically confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) (squamous or non-squamous) or recurrent unresectable disease per the American joint committee on cancer (AJCC) Staging System 9th edition. * Participants must have no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease. * Tumor tissue (fresh or archival) obtained within 5 months of enrollment (signing of informed consent) for each participant must be submitted by the site. * Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Exclusion Criteria * Participants must not have any documented actionable genomic alterations (AGAs) for which first line approved targeted therapies are indicated. * Participants must not have prior treatment with immuno-oncology therapies. * Participants must not have untreated central nervous system (CNS) metastases. * Other protocol-defined Inclusion/Exclusion criteria apply.

Study sites (12)

DC

GA

KY

MD

MS

NE

NY

OH

TX

WI