180 Participants Needed

Petosemtamab + Pembrolizumab for Lung Cancer

Recruiting at 2 trial locations
AR
Overseen ByAlejandro Ricart, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and safety of a new drug combination, petosemtamab and pembrolizumab, for treating certain types of advanced lung cancer. It focuses on individuals with squamous and non-squamous non-small cell lung cancer who have not received systemic therapy before. Participants should have stage IV lung cancer with specific protein levels in their tumors and no prior treatments for their metastatic cancer. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group, offering participants a chance to contribute to important advancements in lung cancer therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot have had any systemic anticancer therapy within 4 weeks before starting the study treatment. It's best to discuss your current medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using petosemtamab with pembrolizumab yields promising results for treating cancer. In studies involving patients with head and neck cancer, this combination helped 67% of them by shrinking or eliminating their cancer.

Although specific safety information for lung cancer is limited, pembrolizumab is already approved for treating various cancers and is generally considered safe. This suggests that the combination might also be safe. The known side effects of pembrolizumab, such as fatigue or nausea, are usually manageable.

This is a Phase 2 trial, indicating that the treatment has already passed initial safety tests in earlier studies. However, it is still under investigation to ensure its safety for a broader population. Joining the trial could involve risks, but it also offers the chance to benefit from a promising treatment.12345

Why do researchers think this study treatment might be promising for lung cancer?

Petosemtamab is unique because it targets specific proteins involved in the growth and spread of cancer cells, which is different from standard chemotherapy that broadly attacks all rapidly dividing cells. Researchers are excited because Petosemtamab, when used together with Pembrolizumab, an immunotherapy drug, may enhance the body's immune response against lung cancer. This combination aims to provide a more targeted and potentially more effective treatment option for patients with non-small cell lung cancer, offering hope for better outcomes and fewer side effects compared to traditional treatments.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

This trial will evaluate the combination of petosemtamab with pembrolizumab for treating lung cancer. Research has shown that this combination is promising. Earlier studies indicated that it helped 67% of patients, with some experiencing a complete disappearance of their cancer. After 12 months, 79% of patients were still alive, and the cancer did not worsen for an average of 9 months. These results suggest the treatment could work for different types of non-small cell lung cancer. Consistent success across various studies increases confidence in its potential.56789

Are You a Good Fit for This Trial?

Adults with metastatic non-small cell lung cancer, either squamous or non-squamous type, can join this trial. They must have normal magnesium and calcium levels, be able to follow study rules and use contraception if needed. Participants should be over 18 years old with a measurable tumor, in good physical condition (ECOG 0 or 1), expected to live at least 12 weeks, have proper blood counts and kidney/liver function.

Inclusion Criteria

I agree to use effective birth control during the study.
I can sign consent and follow study rules, including birth control needs.
I am 18 years old or older.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive petosemtamab in combination with Pembrolizumab as first-line treatment for metastatic non-small cell lung cancer

Up to 6-12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4.5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Petosemtamab

Trial Overview

The trial is testing the effectiveness of a new treatment combination: Petosemtamab plus Pembrolizumab for patients who haven't been treated before for their lung cancer. The goal is to see how well these drugs work together as an initial therapy.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: First line squamous non-small cell lung cancer patientsExperimental Treatment1 Intervention
Group II: First line non-squamous non-small cell lung cancer patientsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merus B.V.

Lead Sponsor

Merus N.V.

Lead Sponsor

Trials
10
Recruited
2,700+

Citations

Dr Fayette on the Efficacy of Petosemtamab Plus ...

The combination elicited an overall response rate (ORR) of 67% (95% CI, 45%-84%), including 1 complete response (CR), 12 partial responses (PRs) ...

Merus' Petosemtamab with Pembrolizumab Interim Data ...

63% response rate observed among 43 evaluable patients. - 79% overall survival rate at 12-months; 9 months median progression-free survival.

Petosemtamab Combo Earns Breakthrough Therapy ...

Among 24 evaluable patients, data showed an overall response rate (ORR) of 67% (n = 16/24; 95% CI, 45%-84%), which included 1 complete response ...

Petosemtamab + Pembrolizumab for Lung Cancer

The study will test the efficacy and safety of petosemtamab in combination with Pembrolizumab in first line patients with squamous non-small ...

Petosemtamab With Pembrolizumab Generates Early ...

“Petosemtamab combined with pembrolizumab in the first line demonstrated a 67% response [rate], regardless of HPV status and regardless of PD-L1 ...

NCT07353957 | Study to Investigate Petosemtamab in ...

The study will test the efficacy and safety of petosemtamab in combination with Pembrolizumab in first line patients with squamous non-small cell lung ...

FDA Grants Breakthrough Therapy Designation to ...

Petosemtamab combined with pembrolizumab shows a 67% ORR in first-line treatment of PD-L1 positive recurrent/metastatic HNSCC. The FDA's ...

Clinical Trials

... trial comparing the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab. ... non-small cell lung cancer (NSCLC) and other solid tumors. Our ...

Petosemtamab (MCLA-158) with pembrolizumab as first- ...

Interim data of petosemtamab monotherapy at the RP2D in 2L/3L HNSCC led to a 37.2% overall response rate (ORR; per investigator) with 6.0 months ...