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NCT Number: NCT06634199

Study of Antitumor Immune Response After cCRT and IO Treatment in Non-resectable III Stage NSCLC Patients

Observational, multicenter, one-arm, non-comparative study. Data will be recorded in a retrospectively manner. The study will be based on secondary data collected from patient clinical chart completed by the doctor during routine visits. The primary objective is describe the antitumor immune response generated in the context of IO (immunotherapy) treatment after cCRT in patients with unresectable NSCLC treated in real world.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Hospitalario Universitario Del Ferrol, Ferrol, A Coruña, Spain

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About this study

The study is based on the collection of blood samples and tumor sample analysis, in real world NSCLC stage IIIA/B and IIIC; PD-L1>1%; non-resectable patients on treatment with IO after cCRT without progression. The patients participating in this study will not receive treatment in relation to the study, no drugs will be provided. Patients will be treated as per standard clinical practice. All data collected for this study will be collected retrospectively from patient clinical chart. Only secondary data collected will be analyzed together will samples analysis information.The duration of the study is expected to be 3 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with histologically- or cytologically- documented NSCLC who present unresectable stage IIIA-IIIB-IIIC disease, according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology).
  • ECOG 0-1.
  • PDL1>1%.
  • Age ≥ 18 years at time of study
  • Patients without progression after cCRT, that are going to receive IO treatment (Durvalumab) for 12 months as subsequent treatment as per standard clinical practice
  • Patient capable of proper therapeutic compliance and accessible for correct follow-up.
  • Patients must have signed, dated and IRB/EC-approved written informed consent form in accordance with regulatory and institutional guidelines.

Exclusion criteria

  • Patients who refuse to sign and date an IRB/IEC-approved written informed consent form.
  • No possibility of venipuncture
  • Any medical, mental, or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.

Treatment and study plan

Durvalumab

Drug

Chemo-radiotherapy + Durvalumab for non-resectable stage III NSCLC patients according to clinical practice of each participant hospital

Other names: Imfinzi

Primary outcomes

  1. Overall survival (OS)

    Time frame: To evaluate the Overall Survival at 12, 18, 24 and 36 months

    Defined from the date of diagnosis to death from any cause. Patients alive at the end of follow-up or lost to follow-up are censored at the last contact time. The probability of remaining free of events at specific timepoints

  2. Progression-free survival (PFS)

    Time frame: To evaluate the Progression-free survival at 12, 18, 24 and 36 months

    Defined from the diagnosis date to the date of investigator-determined disease relapse or death, whichever occurs first. The probability of remaining free of events at specific timepoints

Secondary outcomes

  1. Association between ctDNA clearance (no detection of ctDNA) after IO treatment and Progression free survival (PFS) or Overall survival (OS).

    Time frame: From date of end of treatment until the date of last follow up, assessed up to 36 months

    Association between the baseline ctDNA and ctDNA clearance with each one of the OS or PFS

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Pereira

CONTACT

[email protected]

+34934302006

Sponsors and collaborators

Lead sponsor

Fundación GECP

Other

Registry information

Official study title

Study of Antitumor Immune Response Generated After Concurrent Chemo-radiotherapy (cCRT) and IO Treatment in Non-resectable Stage IIIA/B and IIIC NSCLC Patients Treated in Real World.

Acronym: SIENNA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 9, 2024
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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