Non-small Cell Lung Cancer Stage IIISIENNANCT06634199
Study of Antitumor Immune Response After cCRT and IO Treatment in Non-resectable III Stage NSCLC Patients
An observational study of Non-small Cell Lung Cancer Stage III and PDL1 Gene Mutation, run by Fundación GECP at 22 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Stage III, PDL1 Gene Mutation
- What is being tested?
- Durvalumab
- How many people
- 50 participants
- Where
- 22 sitesSpain
- Study dates
- 3 Oct 2024to 4 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Real world non-small cell lung cancer (NSCLC) stage IIIA/B and IIIC; PD-L1>1%; non-resectable patients in treatment with IO after concurrent chemo-radiotherapy without progression.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
Spain22 sites, 22 recruiting
- Recruiting
Hospitalario Universitario A Coruña
A Coruña, La Coruña, 15006
Rosario García Campelo, MD
Rosario García Campelo, MD
- Recruiting
Hospital General Universitario de Alicante
Alicante, Alicante, 03010
Natividad Martínez-Banaclocha, MD
Natividad Martínez-Banaclocha, MD
- Recruiting
ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Ainhoa Hernández, MD
Ainhoa Hernández, MD
- Recruiting
Hospital Universitari Vall d' Hebron
Barcelona, Barcelona, 08035
Patricia Iranzo, MD
Patricia Iranzo, MD
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041
Andrés Barba, MD
Andrés Barba, MD
- Recruiting
Hospital De Basurto
Bilbao, Bilbao, 48013
Mª Angeles Sala González, MD
Mª Angeles Sala González, MD
- Recruiting
Hospital General Universitario de Ciudad Real
Ciudad Real, Ciudad Real, 13005
Patricia Cruz, MD
Patricia Cruz, MD
- Recruiting
Complejo Hospitalario Universitario Del Ferrol
Ferrol, A Coruña, 15405
Javier Afonso Afonso, MD
Javier Afonso Afonso, MD
- Recruiting
ICO Girona, Hospital Josep Trueta
Girona, Girona, 17007
Joaquim Bosch, MD
Joaquim Bosch, MD
- Recruiting
Hospital Universitari de Gran Canària Doctor Negrín
Las Palmas de Gran Canaria, Las Palmas, 35010
David Aguiar Bujanda, MD
David Aguiar Bujanda
- Recruiting
Hospital Universitario Lucus Augusti
Lugo, Lugo, 27003
Begoña Campos, MD
Begoña Campos, MD
- Recruiting
Hospital Universitario De La Princesa
Madrid, Madrid, 28006
Jose Miguel Sanchez Torres, MD
Jose Miguel Sanchez Torres
- Recruiting
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Carlos Aguado, MD
Carlos Aguado, MD
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040
Manuel Dómine, MD
Manuel Dómine, MD
- Recruiting
Hospital Universitario La Paz
Madrid, Madrid, 28046
Javier de Castro, MD
Javier de Castro, MD
- Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Mariano Provencio, MD
Mariano Provencio, MD
- Recruiting
Hospital Universitario Central De Asturias
Oviedo, Oviedo, 33011
Sena Valcárcel González, MD
Sena Valcárcel González, MD
- Recruiting
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010
Ana Cardeña Gutierrez, MD
Ana Cardeña Gutierrez, MD
- Recruiting
Hospital Virgen del Rocio
Seville, Sevilla, 41013
Reyes Bernabé, MD
Reyes Bernabé, MD
- Recruiting
Hospital Universitario Y Politécnico La Fe
Valencia, Valencia, 46026
Oscar Juan, MD
Oscar Juan, MD
- Recruiting
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, 47003
Andrea Medina del Valle, MD
Andrea Medina del Valle, MD
- Recruiting
Complexo Hospitalario Universitario De Vigo
Vigo, Vigo, 36204
Martín Lazaro, MD
Martín Lázaro, MD
About this study
Official 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.
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.
Read the detailed description
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.
- Being tested
- Durvalumab
- Keywords
- Lung Cancer, Chemo radiotherapy, ctDNA, Inmunotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called Imfinzi
Chemo-radiotherapy + Durvalumab for non-resectable stage III NSCLC patients according to clinical practice of each participant hospital
| Study group | Role | What they receive |
|---|---|---|
| Observational Study Group | Real world non-small cell lung cancer (NSCLC) stage IIIA/B and IIIC; PD-L1>1%; non-resectable patients in treatment with IO after concurrent chemo-radiotherapy without progression. Receives: Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
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
Measured: To evaluate the Overall Survival at 12, 18, 24 and 36 months
Progression-free survival (PFS)
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
Measured: To evaluate the Progression-free survival at 12, 18, 24 and 36 months
Secondary outcomes (1)
Association between ctDNA clearance (no detection of ctDNA) after IO treatment and Progression free survival (PFS) or Overall survival (OS).
Association between the baseline ctDNA and ctDNA clearance with each one of the OS or PFS
Measured: From date of end of treatment until the date of last follow up, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start3 Oct 2024
- Primary completion4 Nov 2027 (estimated)
- Study completion4 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer Stage IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación GECP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariano Provencio, MD, Study chair, Fundación GECP President
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634199
- Sponsor's protocol ID
- GECP 23/04_SIENNA
- Acronym
- SIENNA
- Status last verified
- Jan 2026
- First submitted
- 7 Oct 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06634199
- Acronym / sponsor ID
- SIENNA / GECP 23/04_SIENNA
- Keywords
- Lung Cancer, Chemo radiotherapy, ctDNA, Inmunotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fundación GECPUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 4 Nov 2027 (estimated)
- Study completion
- 4 Nov 2027 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Study Group | – | Drug: DurvalumabReal world non-small cell lung cancer (NSCLC) stage IIIA/B and IIIC; PD-L1>1%; non-resectable patients in treatment with IO after concurrent chemo-radiotherapy without progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Real world non-small cell lung cancer (NSCLC) stage IIIA/B and IIIC; PD-L1>1%; non-resectable patients in treatment with IO after concurrent chemo-radiotherapy without progression.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: ImfinziChemo-radiotherapy + Durvalumab for non-resectable stage III NSCLC patients according to clinical practice of each participant hospital | Drug | Observational Study Group |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Web page of the sponsor where users can find more information about Fundación GECP studiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mariano Provencio, MD study chair
Fundación GECP President
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer Stage III and PDL1 Gene Mutation, run by Fundación GECP at 22 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Pereira (+34934302006, gecp@gecp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: To evaluate the Overall Survival at 12, 18, 24 and 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.