INTerpath-009: This study is recruiting people with previously untreated non-small cell lung cancer to test if a personalised cancer vaccine plus immunotherapy after surgery can prevent the cancer from returningA 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 (INTerpath-009)

Trial purpose

Cancer treatment

Tumor type

Lung cancer

Age

18+

Trial acronym

INTerpath-009

Summary

The goal of this study is to learn if people who receive a personalised cancer vaccine (called intismeran autogene) and immunotherapy after surgery are cancer-free longer than people who receive a 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 tumours did not respond completely to treatment before surgery (neoadjuvant treatment).

Eligible participants will be randomly allocated (by chance) to one of two treatment arms (Experimental Arm or Active Comparator Arm).

Treatment details
Before surgery (neoadjuvant treatment), participants will receive the following every 3 weeks for up to 4 treatment cycles:

• pembrolizumab immunotherapy IV infusion and
• standard background chemotherapy (specific drugs to be chosen by your doctor).

Participants will then have a surgical resection (removal) of their cancer.

After surgery (adjuvant treatment), participants will receive:

• pembrolizumab IV infusion every 6 weeks for up to 7 cycles
• plus one of the following injections every 3 weeks for up to 9 doses
  • intismeran autogene (experimental group)
  • placebo (active comprator group).

Conditions

This trial is treating people with stage II, IIIA or IIIB (N2) non-small cell lung cancer (NSCLC) that is able to be removed with surgery (resectable)