Pembrolizumab and Intismeran for Non-Small Cell Lung Cancer

A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)

Recruiting Phase 3 Interventional Study
Carcinoma, Non-Small-Cell Lung
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
680 (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
Who this trial is looking for

This trial is looking for people with non-small cell lung cancer who did not have a complete response to treatment before surgery. Participants will receive either a combination of two treatments or a placebo along with pembrolizumab after surgery.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with non-small cell lung cancer
  • I have not received previous treatment for my cancer
  • I have a good performance status
  • I have not achieved a complete response after chemotherapy
  • My tumors do not have specific genetic mutations for other treatments
  • I am well controlled on HIV treatment, if applicable
  • I have undetectable hepatitis B or C viral loads, if applicable

You may not be able to join if

  • I have been diagnosed with small cell lung cancer
  • I have had previous treatment for my current lung cancer
  • I have received prior therapy with PD-1 or PD-L1 agents
  • I have received prior systemic cancer treatments outside this study
  • I have received prior treatment with a cancer vaccine
  • I have had radiation therapy within the last 2 weeks
  • I have received a live vaccine within the last 30 days

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond comple…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable clinical Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) \[American J…
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