Pumitamig vs Durvalumab for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments, Pumitamig (a new potential drug) and Durvalumab, to determine which is more effective for individuals with Non-small Cell Lung Cancer (NSCLC) that cannot be surgically removed. It targets those who have already undergone a combination of chemotherapy and radiation without cancer progression. Suitable candidates have confirmed NSCLC, have completed at least two cycles of specific chemotherapy and radiation, and have not experienced cancer progression after this treatment. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Pumitamig, when combined with chemotherapy, generally has a manageable safety profile for patients. Side effects are usually mild and align with expectations from past studies. No new safety concerns emerged, and few patients discontinued treatment early due to side effects. Although serious side effects occurred, they were uncommon, indicating that the treatment is generally well-tolerated.
Durvalumab has already received FDA approval for certain types of lung cancer, confirming its safety through thorough human testing. While it can cause side effects, these are typically known and manageable with medical care.
Both Pumitamig and Durvalumab have demonstrated safety in treating conditions like lung cancer, though monitoring for side effects during treatment remains important.12345Why do researchers think this study treatment might be promising?
Pumitamig is unique because it targets lung cancer cells differently from the current standard treatments like chemotherapy and immunotherapy. Most treatments for lung cancer work by either killing fast-growing cells or boosting the immune system to attack cancer cells. But Pumitamig introduces a novel mechanism by specifically targeting certain proteins involved in cancer cell growth, offering the potential for more precise and effective treatment. Researchers are excited about Pumitamig because it could lead to fewer side effects and improve outcomes for patients who might not respond well to existing therapies.
What evidence suggests that this trial's treatments could be effective for lung cancer?
This trial will compare Pumitamig with Durvalumab for lung cancer. Research has shown that Pumitamig, a special type of antibody, produces promising results in fighting cancer. In earlier studies with patients who have small cell lung cancer, Pumitamig slowed the cancer and helped patients live longer without progression. This suggests it might also be effective for non-small cell lung cancer. The treatment targets two pathways that aid cancer growth, potentially increasing its effectiveness. While more research is needed, these findings offer a positive sign for those considering this treatment option.15678
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for adults with Stage III Non-small Cell Lung Cancer that can't be removed by surgery. They must have finished at least two rounds of platinum-based chemo and radiation without their cancer getting worse, and be in good physical shape (able to perform daily activities). People with autoimmune diseases, certain gene mutations, serious lung or heart conditions, or those who've had other recent cancer treatments can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Concurrent Chemoradiation Therapy
Participants receive platinum-based concurrent chemoradiation therapy
Treatment
Participants receive either Pumitamig or Durvalumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Durvalumab
- Pumitamig
Trial Overview
The study compares Pumitamig and Durvalumab as follow-up treatments after patients have already received chemoradiation therapy. The goal is to see which drug works better at keeping the cancer from advancing further in people whose tumors couldn’t be surgically removed.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
BioNTech SE
Industry Sponsor
Prof. Dr. Ugur Sahin
BioNTech SE
Chief Executive Officer since 2008
MD from University of Cologne
Prof. Özlem Türeci
BioNTech SE
Chief Medical Officer since 2018
MD from Saarland University
Citations
PD-L1xVEGF-A bispecific antibody pumitamig (BNT327/ ...
“Today's data add to the growing body of evidence indicating the potential of pumitamig to improve outcomes across a wide range of solid tumors, ...
NCT07361510 | A Study to Evaluate the Efficacy of ...
The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung ...
3.
ddw-online.com
ddw-online.com/bispecific-antibody-trial-shows-encouraging-antitumour-activity-36440-202509/Bispecific antibody trial shows encouraging antitumour ...
The interim analysis included 43 patients with untreated extensive-stage small cell lung cancer (Cohort 1) who received pumitamig in combination ...
4.
pharmacytimes.com
pharmacytimes.com/view/pumitamig-shows-positive-trend-in-pfs-treating-patients-with-es-sclcPumitamig Shows Positive Trend in PFS Treating Patients ...
Interim trial data presented at the 2025 World Conference on Lung Cancer shows pumitamig's promising efficacy in patients with extensive ...
5.
investors.biontech.de
investors.biontech.de/system/files-encrypted/nasdaq_kms/assets/2025/11/11/13-27-51/BNTX%20Innovation%20Series%20%28R%26D%29%20Day%202025_final_%20website.pdfQ2 2025 BNTX Presentation - BioNTech
Non-Small Cell Lung Cancer is One of the Highest Incidence Cancers Globally1. 63. 1. Globocan – Cancer Tomorrow. 2. CancerMPact® 2024 ...
Study Details | NCT06712316 | Safety, Efficacy, and ...
This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC).
7.
clinicaltrialsarena.com
clinicaltrialsarena.com/news/biontech-bms-pumitamig-bispecific-tnbc-phase-ii/BioNTech and BMS' bispecific touts 59.3% nine-month PFS ...
Alongside its promising efficacy, pumitamig plus chemotherapy was fairly well tolerated, with severe treatment-emergent adverse events (TEAEs) ...
Global Phase 2 Randomized Trial of BNT327 (Pumitamig; ...
... Pumitamig (BNT327/BMS986545) in Patients with Extensive-Stage Small Cell Lung Cancer Shows Encouraging Antitumor Activity. "The data are being presented ...
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