Observational study on treatment duration of PD1/PDL1 inhibitors in lung cancer patients

Observational Retro-prospective Study on Programmed Cell Death 1/ Programmed Cell Death Ligand1 (PD1/PDL1) Inhibitors Treatment Duration in Patients With Non Small Cell Lung Carcinoma

This study looks at how long people with non-small cell lung cancer can safely stay on PD1/PDL1 inhibitors and whether continuing treatment for more than 24 months helps them feel better.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Milano Bicocca (Academic / other)
• Drugs / interventions: Pembrolizumab, Nivolumab, Atezolizumab, immunotherapy, radiation
• Locations: 10 sites (Ancona and 9 other locations)
• Trial ID: NCT05418660 on ClinicalTrials.gov

What this trial studies

This observational study aims to analyze the treatment duration of PD1/PDL1 inhibitors in patients with non-small cell lung cancer (NSCLC) who have been treated for at least 24 months. It will involve a multicenter, international approach, categorizing patients into two cohorts based on whether they continued or stopped treatment after 24 months. The study will assess the effectiveness and safety of immunotherapy, considering various baseline characteristics and biomarkers that may predict treatment response. The goal is to gather data that could inform optimal treatment duration and improve patient quality of life.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed NSCLC who have received PD1/PDL1 inhibitors for at least 24 months and have shown a complete or partial response.

Not a fit: Patients who have not received at least 24 months of treatment with PD1/PDL1 inhibitors or those with other types of lung cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify the optimal duration of immunotherapy for NSCLC patients, potentially reducing side effects and improving quality of life.

How similar studies have performed: Other studies have shown promising results with PD1/PDL1 inhibitors in NSCLC, but this specific approach to treatment duration is novel and requires further investigation.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years
2. Histologically / cytologically confirmed diagnosis of NSCLC, with or without brain metastases
3. Illness measurable according to Response Evaluation Criteria in Solid Tumours (iRECIST) criteria
4. At least 24 months of treatment with Pembrolizumab, Nivolumab or Atezolizumab
5. Complete response (CR)/ partial response (RP)/ stable disease at the end of 24-month treatment. The maintenance of the response may also have been obtained after loco-regional treatment, e.g. surgery or radiotherapy, in the case of oligoprogression for a maximum of 3 locoregional treatments (e.g. radiotherapy, surgery) throughout the period of treatment and suspension. Even progression at the brain level, treated with radiation therapy or surgery, can be considered, provided that it is followed by a disease control for at least 3 months.
6. At least 3 months of follow-up or death within three months after stopping the 24-month treatment.
7. Informed consent freely granted and acquired before the start of the study, for alive and contactable patients.

Exclusion Criteria:

1. Initial chemo-immunotherapy treatment or association with other immunotherapy or other drugs in the context of clinical trials.
2. Permanent discontinuation of treatment with anti PD-1 / PD-L1 for adverse events.
3. More than 3 loco-regional treatments for maintaining the radiological response
4. Suspension of immunotherapy for a period longer than 40 days during the 24-month treatment.

Where this trial is running

Ancona and 9 other locations

• AOU Ospedali Riuniti — Ancona, Italy (Recruiting)
• Azienda Ospedaliero Universitaria Careggi — Firenze, Italy (Recruiting)
• Ospedale Policlinico San Martino — Genova, Italy (Recruiting)
• Azienda Ospedaliero Universitaria — Modena, Italy (Recruiting)
• Fondazione IRCCS San Gerardo dei Tintori — Monza, Italy (Recruiting)
• Istituto Nazionale dei Tumori — Napoli, Italy (Recruiting)
• Azienda Ospedaliero Universitaria San Luigi — Orbassano, Italy (Recruiting)
• Azienda Ospedaliero Universitaria — Parma, Italy (Recruiting)
• Azienda Ospedaliera Marche Nord — Pesaro, Italy (Recruiting)
• Azienda Sanitaria Universitaria Friuli Centrale — Udine, Italy (Recruiting)

Study contacts

• Principal investigator: Diego Cortinovis, MD — Fondazione IRCCS San Gerardo dei Tintori, Monza
• Study coordinator: Diego Cortinovis, MD

Conditions Non-small Cell Lung Cancer; NSCLC; Immunotherapy; nivolumab; atezolizumab; pembrolizumab