RightFit
RecruitingPhase 3

Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor

A Randomised, Open-label, Phase 3 Trial Comparing the Efficacy and Safety of OSE2101 Versus Docetaxel in HLA-A2 Positive Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) With Secondary Resistance to Immune Checkpoint Inhibitor

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests OSE2101, a cancer treatment vaccine, against docetaxel, a chemotherapy drug. It is for adults with non-small cell lung cancer that has spread and has become resistant to immune checkpoint treatment after first responding. Patients must also have HLA-A2, a marker found by a blood test.

Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance. Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have the HLA-A2 marker, confirmed by the study’s blood test.
  • Have non-small cell lung cancer confirmed by tissue or cell tests. Both squamous and non-squamous types can qualify.
  • Have cancer that has spread and cannot be treated with surgery or radiation aimed at curing it.
  • Have cancer that became resistant to immune checkpoint treatment, which helps the immune system fight cancer, after first responding.
  • Do not have EGFR, ALK, or ROS1 gene changes that qualify for targeted drugs. Testing is not required for people with squamous cancer who are at least 50 and have smoked at least 15 pack-years, such as one pack a day for 15 years.
  • Some other gene changes, such as KRAS G12C or BRAF, may be allowed if targeted drugs are not available locally and the study sponsor agrees.
  • Other study entry rules also apply.

Who can't join

    Simplified for readability. The official criteria below are what the study team uses.

    Official eligibility criteria

    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.

    Study sites (79)

    CA

    CO

    CT

    DC

    FL

    IL

    KS

    LA

    MA

    MD

    NE

    NY

    OH

    SC

    TN

    WA