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.

ROSETTA Lung-201: Pumitamig vs. Durvalumab for Stage III NSCLC after Chemoradiation

NCT: NCT07361497 · Status: RECRUITING · Phase: Phase 3 · Sponsor: Bristol-Myers Squibb · Started: 2026-03-16 · Est. Completion: 2033-12-31

Plain English Summary

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) is a Phase 3 clinical trial sponsored by Bristol-Myers Squibb studying Non-small Cell Lung Cancer (NSCLC). This trial tests if Pumitamig is as good as or better than Durvalumab in treating a specific type of lung cancer. It's for patients with unresectable Stage III Non-small Cell Lung Cancer (NSCLC) who have finished chemoradiation without their cancer getting worse. Participants will receive either Pumitamig or Durvalumab, and will be monitored regularly. Standard treatment after chemoradiation for this condition is the main alternative being compared. The trial aims to enroll 850 participants.

Official Summary

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

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you have Stage III NSCLC that cannot be removed by surgery and have completed at least 2 cycles of chemotherapy and radiation without the cancer progressing. You must have a good general health status (ECOG score of 0 or 1). You cannot join if you have certain genetic mutations (EGFR, ALK) if you have non-squamous NSCLC, have active autoimmune diseases, significant heart problems, or recent major blood clots or bleeding. You also cannot join if you have advanced lung disease, a history of lung inflammation requiring steroids, or have had any other cancer treatment for this stage of disease. This trial is studying Non-small Cell Lung Cancer (NSCLC), so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to see how long patients live without their cancer getting worse (progression-free survival), meaning the treatment is working to control the disease. The specific primary outcome measures are: Progression-free survival (PFS) by blinded independent central review (BICR) (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) (Up to 3 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a critical need for new treatments for patients with Stage III NSCLC who have completed chemoradiation, aiming to prevent cancer progression and improve outcomes. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Non-small Cell Lung Cancer (NSCLC), where improved treatment options are needed.

Investor Insight

This Phase 3 trial, sponsored by Bristol-Myers Squibb, is a significant investment in a competitive market for advanced lung cancer therapies, with a focus on improving upon existing standards of care Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 850 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if Pumitamig or Durvalumab is the right choice for you and what the potential benefits and risks are. Be prepared for regular clinic visits for treatment, scans, and blood tests to monitor your health and cancer. Understand that this is an open-label study, meaning both you and your doctor will know which treatment you are receiving. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full 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.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07361497?

NCT07361497 is a Phase 3 INTERVENTIONAL study titled "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)." It is currently recruiting and is sponsored by Bristol-Myers Squibb. The trial targets enrollment of 850 participants.

What conditions does NCT07361497 study?

This trial investigates treatments for Non-small Cell Lung Cancer (NSCLC). The primary condition under study is Non-small Cell Lung Cancer (NSCLC).

What treatments are being tested in NCT07361497?

The interventions being studied include: Pumitamig (DRUG), Durvalumab (DRUG). Specified dose on specified days

What does Phase 3 mean for NCT07361497?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT07361497?

This trial is currently "Recruiting." It started on 2026-03-16. The estimated completion date is 2033-12-31.

Who is sponsoring NCT07361497?

NCT07361497 is sponsored by Bristol-Myers Squibb. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07361497?

The trial aims to enroll 850 participants. The trial is currently recruiting and accepting new participants.

How is NCT07361497 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT07361497?

The primary outcome measures are: Progression-free survival (PFS) by blinded independent central review (BICR) (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) (Up to 3 years). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07361497 being conducted?

This trial is being conducted at 20 sites, including Daphne, Alabama; Chandler, Arizona; Golden, Colorado; Newark, Delaware and 16 more sites (United States).

Where can I find official information about NCT07361497?

The official record for NCT07361497 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07361497. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07361497 testing in simple terms?

This trial tests if Pumitamig is as good as or better than Durvalumab in treating a specific type of lung cancer. It's for patients with unresectable Stage III Non-small Cell Lung Cancer (NSCLC) who have finished chemoradiation without their cancer getting worse.

Why is this trial significant?

This trial addresses a critical need for new treatments for patients with Stage III NSCLC who have completed chemoradiation, aiming to prevent cancer progression and improve outcomes. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT07361497?

Common side effects may include fatigue, nausea, diarrhea, and skin reactions. More serious risks can involve lung inflammation (pneumonitis), liver problems, or severe allergic reactions. Both Pumitamig and Durvalumab can affect your immune system, potentially leading to autoimmune side effects. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07361497?

Ask your doctor if Pumitamig or Durvalumab is the right choice for you and what the potential benefits and risks are. Be prepared for regular clinic visits for treatment, scans, and blood tests to monitor your health and cancer. Understand that this is an open-label study, meaning both you and your doctor will know which treatment you are receiving. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07361497 signal from an investment perspective?

This Phase 3 trial, sponsored by Bristol-Myers Squibb, is a significant investment in a competitive market for advanced lung cancer therapies, with a focus on improving upon existing standards of care This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participants will receive either Pumitamig or Durvalumab, and will be monitored regularly. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.