Active Cancer NIHR-supported project Lungs & Breathing

Phase 3 Randomized Double-blind Placebo-controlled Study of Adjuvant Pembrolizumab W/WO V940 in Resectable Stages II-IIIB(N2) NSCLC for patients not achieving pCR after receiving Neoadjuvant Pembrolizumab with Platinum-based Doublet Chemotherapy Followed by Surgery

Funder NIHR (part of DHSC)
Recipient organisation NIHR Bristol Clinical Research Facility
NIHR support Recorded as supported by this research centre
Period Jan 2025 — Nov 2028

In plain English

AI plain-English summary

A third of patients with resectable non-small cell lung cancer (NSCLC) will see their tumours fail to fully disappear after pre-surgery chemotherapy and immunotherapy, leaving them at high risk of relapse. This phase 3 trial tests whether adding a personalised cancer vaccine (V940) to standard post-surgery immunotherapy (pembrolizumab) can keep those patients cancer-free for longer. The problem is stark: even after surgery and modern neoadjuvant treatment, residual cancer cells in the removed tissue signal a poor prognosis. Current post-surgery care offers no targeted option for these patients. This trial randomises 680 adults who did not achieve a complete pathological response to receive either V940 plus pembrolizumab or placebo plus pembrolizumab for up to 10 months after surgery, with neither patient nor doctor knowing who gets the vaccine. If V940 proves effective, it would give surgeons and oncologists a new tool to prevent recurrence in the highest-risk surgical NSCLC patients—a group currently left with few options beyond surveillance. The study runs for up to 12 years per participant, tracking how long they remain cancer-free.

View original technical description
Researchers are looking for new ways to treat non-small cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer and can sometimes be removed with surgery. Researchers want to know if giving V940 and pembrolizumab, the study medicines, after surgery can help prevent the cancer from coming back in people with NSCLC whose tumours did not respond completely to neoadjuvant (pre surgical) treatment. V940 is designed to help a person’s immune system attack their specific cancer. Pembrolizumab is an immunotherapy.The goal of this study is to learn if participants who receive V940 and pembrolizumab after surgery are cancer free longer than participants who receive placebo and pembrolizumab. About 680 participants with NSCLC will be in this study. They will be at least 18 years old and:• Have NSCLC that can be removed with surgery • Can receive pembrolizumab and chemotherapy• Have not had prior treatment for NSCLCParticipants will have surgery to remove the NSCLC and will also receive 3 of these treatments:• Chemotherapy of the researcher’s choice before surgery• Pembrolizumab every 3 weeks before surgery and every 6 weeks after surgery• V940 every 3 weeks after surgery• Placebo every 3 weeks after surgeryParticipants may be in this study for about 12 years. This study has 2 parts:Part 1 (before surgery): Participants will receive pembrolizumab and chemotherapy for 3 months and then have surgery to remove the NSCLC. Part 2 (after surgery): Participants who have signs of cancer cells in their tissues removed during surgery will have an equal chance to receive either:• V940 for about 4 months and pembrolizumab for about 10 months• Placebo for about 4 months and pembrolizumab for about 10 monthsNeither the participants nor the researchers will know if a person receiving V940 or placebo (double-blind study).

Researchers

Gareth Ayre (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

Phase 3 Randomized Double-blind Placebo-controlled Study of Adjuvant Pembrolizumab W/WO V940 in Resectable Stages II-IIIB(N2) NSCLC for patients not achieving pCR after receiving Neoadjuvant Pembrolizumab with Platinum-based Doublet Chemotherapy Followed by Surgery (V940-009)
A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy
A Phase 2/3, adaptive, randomized, open-label, clinical study to evaluate neoadjuvant and adjuvant V940 (mRNA-4157) in combination with pembrolizumab (MK-3475) versus standard of care and pembrolizumab monotherapy in participants with resectable locally advanced cutaneous squamous cell carcinoma (LA cSCC)
A Phase 2/3, adaptive, randomized, open-label, clinical study to evaluate neoadjuvant and adjuvant V940 (mRNA-4157) in combination with pembrolizumab (MK-3475) versus standard of care, and pembrolizumab monotherapy in participants with resectable locally advanced cutaneous squamous cell carcinoma (LA cSCC) (INTerpath-007)
A Phase 2, Randomized, Double-blind, Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Participants With Renal Cell Carcinoma

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