Active Cancer NIHR-supported project Lungs & Breathing

MK2870-023 A Phase 3 Study of Pembrolizumab in combination with Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) followed by Pembrolizumab with or without maintenance MK 2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer

In plain English

AI plain-English summary

A new trial is testing whether adding a targeted drug called MK-2870 to the immunotherapy pembrolizumab can help people with metastatic squamous non-small cell lung cancer live longer. This matters because current first-line treatment—chemotherapy plus pembrolizumab—does not work for everyone, and the cancer often becomes resistant. MK-2870 works differently: it attaches to specific targets on cancer cells and delivers a treatment that destroys them directly. The trial asks whether combining this targeted attack with immunotherapy can improve outcomes beyond what pembrolizumab alone can achieve. If the combination proves effective, it could offer a new standard maintenance therapy for a common and aggressive form of lung cancer. People whose disease does not worsen after initial chemotherapy and immunotherapy would then have a second, more targeted option to keep the cancer in check for longer. This would directly affect the daily lives of patients by potentially extending survival and delaying the need for further, more toxic treatments.

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Researchers are looking for new ways to treat people with metastatic non-small cell lung cancer (NSCLC). Current treatments for metastatic NSCLC are chemotherapy and immunotherapy. Pembrolizumab and MK-2870 are the trial medicines. MK-2870 attaches to specific targets on cancer cells and delivers treatment to destroy those cells.Researchers want to learn if adding MK-2870 to pembrolizumab can treat metastatic NSCLC. The goal of this trial is to learn if people who receive pembrolizumab with MK-2870 live longer overall compared to pembrolizumab alone.About 851 people, aged at least 18 years old, will be in this trial and:• Have metastatic squamous NSCLC• Have not received treatments for metastatic NSCLC• Do not have another type of lung cancerThis trial has 2 parts:Part 1 (Induction therapy): Everyone will receive pembrolizumab and chemotherapy for about 3 months as their first treatment.Part 2 (Maintenance therapy): People who don’t have the cancer get worse after completing induction therapy will receive more treatment. In Part 2, people will have an equal chance to receive:• Pembrolizumab with MK-2870 OR• Pembrolizumab alonePeople will receive 2 or all of these treatments through a needle into a vein (intravenous infusion):• Pembrolizumab, given every 3 weeks during Part 1 and every 6 weeks during Part 2• MK-2870, given every 2 weeks during Part 2• Chemotherapy, given every 1 or 3 weeks during Part 1People will receive pembrolizumab for up to about 2 years. People will receive MK-2870 until the cancer gets worse or they don’t tolerate it.Both the people in the trial and the researcher will know which trial treatment a person is getting. During the trial, people will give urine, blood, and tumour samples, have imaging tests and physical examinations, and answer questions.A person may be in this trial for about 5 years.

Researchers

Jason Adhikaree (Principal Investigator)

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A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery
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A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician’s Choice in Participants With Triple Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) At Surgery
An Open-label, Multicenter, Phase 3 Randomized, Active-Comparator- Controlled Clinical Study of Pembrolizumab (MK-3475) in Combination With Sacituzumab Govitecan Versus MK-3475 Monotherapy as First-line Treatment in Participants With PD L1 TPS Greater than or Equal to 50% Metastatic Non-small Cell Lung Cancer (KEYNOTE D46/EVOKE-03)

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