Therapeutic cancer vaccine for patients with advanced lung cancer resistant to immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 clinical trial evaluates the efficacy of OSE2101, a therapeutic cancer vaccine, in patients with non-small cell lung cancer (NSCLC) who have developed secondary resistance to immune checkpoint inhibitors. The study is multicenter and randomized, with participants assigned to either receive OSE2101 monotherapy or standard of care treatment with docetaxel. Patients will be stratified based on their tumor histology and performance status to ensure balanced groups. The trial aims to assess the potential of OSE2101 to improve outcomes in this challenging patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female, aged ≥ 18 years
2. Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory
3. Patients with histologically or cytologically squamous or non-squamous documented NSCLC, metastatic stage at study entry, not eligible for definite surgery or radiation, without EGFR, ALK and ROS1 gene alterations eligible for targeted therapy; for patients with squamous NSCLC, the molecular tests are not mandatory if age ≥ 50 years old and smoker ≥ 15 pack years; other sensitizing mutations known to be immunosensitive are eligible in case of lack of local access to targeted therapy (i.e.; KRAS G12C and BRAF mutations) after Sponsor' agreement.
4. Patients with secondary resistance to ICI;

Other inclusion and exclusion criteria will apply per protocol.

Where it's running

• Clinical Research Advisors, LLC
  Beverly Hills, California, United States Recruiting
• Lutheran Medical Center - Cancer Centers of Colorado
  Wheat Ridge, Colorado, United States Recruiting
• Eastern Connecticut Hematology and Oncology Associates
  Norwich, Connecticut, United States Recruiting
• Georgetown Lombardi Comprehensive Cancer Center
  Washington D.C., District of Columbia, United States Recruiting
• Cancer Specialists of North Florida - Fleming Island
  Fleming Island, Florida, United States Recruiting
• Cancer Specialists of North Florida - Riverside
  Jacksonville, Florida, United States Recruiting

+157 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Caroline Chevalier, MSc, MPH
• Email: caroline.chevalier@ose-immuno.com
• Phone: +33 630 842 002

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.