Stage IIIA Non-small Cell Lung CancerPLANETNCT05167487
Pathological Response After Neoadjuvant Treatment on NSCLC
An observational study of Stage IIIA Non-small Cell Lung Cancer, run by Fundación GECP at 17 sites in Spain.
Trial summary
This is a non-interventional, observational, multicenter and retrospective study. Being limited to the collection of patient data already filled in the Tumor Thoracic Registry data base and the data from stage IIIA clinical trials case report forms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IIIA Non-small Cell Lung Cancer
- What is being tested?
- Cisplatin and Carboplatin
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 17 sitesSpain
- Study dates
- 13 Dec 2021to 1 Dec 2028
- 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: The study will include all resectable stage IIIA patients who have received platinum-based neoadjuvant treatment and surgery and that were diagnosed as stage IIIA from 2010 to 2017.The cohort of patients identified for the current study will be based on a portion of patients included in the Thoracic Tumor Registry (TTR) and in stage IIIA clinical trials approved by Spanish Health Authorities which the sponsor is Fundación GECP.
Who may be able to join
- Patients with resectable stage IIIA disease (according to American Joint Committee on Cancer [AJCC] lung cancer edition 7 or 8) who were included in the Tumor Thoracic Registry data base and in stage IIIA clinical trials which the sponsor is Fundación GECP.
- Patients with histologically N2 involvement confirmed
- Patients diagnosed as stage IIIA from 2010 and 2017
- Patients who have received neoadjuvant platinum-based treatment and surgery
- Age ≥ 18 years at time of study entry
- PET /TC at diagnosis
Who cannot join
- Patients who received chemoradiotherapy neoadjuvant treatment
- Patients who were not resected after neoadjuvant treatment
- Patients who were diagnosed after June 2017
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
Spain17 sites, 17 recruiting
- Recruiting
Hospital Universitario De A Coruna
A Coruña, A Coruña, 15006
Teresa Hermida, MD
Teresa Hermida, MD
- Recruiting
Hospital General Universitario de Alicante
Alicante, Alicante, 03010
Ignacio Aranda, MD
Ignacio Aranda, MD
- Recruiting
ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
José Luis Mate, MD
José Luis Mate, MD
- Recruiting
Hospital Universitario Cruces
Barakaldo, Vizcaya, 48903
Mónica Saiz, MD
Mónica Saiz, MD
- Recruiting
Hospital Vall d'Hebron
Barcelona, Barcelona, 08035
Irene Sansano, MD
Irene Sansano, MD
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041
Laura López Vilaró, MD
Laura López Vilaró, MD
- Recruiting
ICO Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908
Nuria Baixeras, MD
Nuria Baixeras, MD
- Recruiting
Hospital Universitario Insular de Gran canaria
Las Palmas de Gran Canaria, Gran Canaria, 35016
Maria del Carmen Camacho, MD
Maria del Carmen Camacho, MD
- Recruiting
Hospital Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, 35010
María Luz Plaza, MD
María Luz Plaza
- Recruiting
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Melchor Saiz Pardo, MD
Melchor Saiz Pardo, MD
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040
Federico Rojo, MD
Federico Rojo, MD
- Recruiting
Hospital 12 De Octubre
Madrid, Madrid, 28041
Ana Belén Enguita, MD
Ana Belén Enguita, MD
- Recruiting
Hospital Universitario la Paz
Madrid, Madrid, 28046
Isabel Esteban, MD
Isabel Esteban, MD
- Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Mariano Provencio, MD
Clara Salas, MD
- Recruiting
Hospital Universitario Regional de Málaga
Málaga, Málaga, 29010
Pino Flores, MD
Pino Flores, MD
- Recruiting
Hospital Universitario La Fe
Valencia, Valencia, 46026
Nuria Mancheño, MD
Nuria Mancheño, MD
- Recruiting
Complejo Hospitalario Universitario de Vigo
Vigo, Pontevedra, 36036
Ana González, MD
Ana González, MD
About this study
Official title: Retrospective Observational Study of Resectable Stage IIIA Non-small Cell Lung Cancer Patients: Pathological Response After Neoadjuvant Treatment and Patient Outcomes
This is a non-interventional, observational, multicenter and retrospective study. Being limited to the collection of patient data already filled in the Tumor Thoracic Registry data base and the data from stage IIIA clinical trials case report forms.
Read the detailed description
This is a non-interventional, observational, multicenter and retrospective study that will not under any circumstances interfere in the physician's normal clinical practice. Being limited to the collection of patient data already filled in the Tumor Thoracic Registry (TTR) data base and the data from stage IIIA clinical trials case report forms, it does not entail any diagnostic or therapeutic procedure outside of normal clinical practice.
The primary objective is to assess pathological response after neoadjuvant treatment as a subrogate endpoint for overall survival and disease-free survival in resectable stage IIIA non-small cell lung cancer patients.
It is estimated that around 15-20 Spanish sites are enrolling patients with these characteristics in the TTR or in the stage IIIA clinical trials of the Fundación GECP.
Pathologists and physician's of these sites will be invited to participate in the PLANET study as all cases will be clinical-pathologically re-evaluated to reach the study objectives. Each pathologist will re-evaluate the specimens from the selected patients under common criteria.The sample size would be 150 patients enrolled in the study.
- Conditions
- Stage IIIA Non-small Cell Lung Cancer
- Being tested
- Cisplatin, Carboplatin
- Keywords
- Neoadjuvant Treatment, Observational study, Resectable IIIA patients, Non small cell lung cancer, Pathological response
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called Cis-diammine-dichloroplatinum, Platinol
Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.
CarboplatinDrug
Also called Paraplatin
Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: platinum-based neoadjuvant treatment and surgery. | Resectable stage IIIA non-small cell lung cancer patients treated with platinum-based neoadjuvant treatment and surgery. Receives: Drug: Cisplatin; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess pathological response after neoadjuvant treatment as a subrogate endpoint for overall survival and disease-free survival in resectable stage IIIA non-small cell lung cancer patients.
Pathological response will be assessed as complete pathological response, major pathological response (defined as ≤10% of viable tumor cells) and incomplete pathological response.
Measured: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months
Secondary outcomes (4)
To describe the percentage of residual viable tumor in this population of patients under common criteria
- No response or more than 70% of viable tumor: Lymph node major pathological response negative (LN-MPR)- B) ≤70% of viable tumor cells: Lymph node major pathological response positive (LN-MPR)+ C) No evidence of any viable tumor (including primary tumor): Complete pathological response
Measured: From the end of neoadjuvant treatment until the last follow up or death,assessed up to 45 months
To describe the histopathological changes within tumor bed associated to tumor response
Types of histopathological changes within tumor bed: fibrosis, lymphoid aggregates and others
Measured: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months
To correlate pathological response and post-surgical complications
Pathological response will be assessed as complete pathological response, major pathological response (defined as ≤10% of viable tumor cells) and incomplete pathological response.
Measured: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months
To describe the relation between nodal downstaging after neoadjuvant treatment and overall survival
Downstaging after surgery is a reduction in the stage of a cancer. Overall Survival defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive.
Measured: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start13 Dec 2021
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IIIA Non-small Cell Lung CancerStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación GECP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariano Provencio, MD, Study chair, President of Grupo Español de Cáncer de Pulmón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167487
- Sponsor's protocol ID
- GECP 21/03_PLANET
- Acronym
- PLANET
- Status last verified
- Feb 2026
- First submitted
- 5 Nov 2021
- Last updated
- 6 Feb 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 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Study of Resectable Stage IIIA Non-small Cell Lung Cancer Patients: Pathological Response After Neoadjuvant Treatment and Patient Outcomes
- ClinicalTrials.gov ID
- NCT05167487
- Acronym / sponsor ID
- PLANET / GECP 21/03_PLANET
- Conditions
- Stage IIIA Non-small Cell Lung Cancer
- Keywords
- Neoadjuvant Treatment, Observational study, Resectable IIIA patients, Non small cell lung cancer, Pathological response
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fundación GECPUniversity, hospital or other
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 22 Dec 2021 (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.
This is a non-interventional, observational, multicenter and retrospective study. Being limited to the collection of patient data already filled in the Tumor Thoracic Registry data base and the data from stage IIIA clinical trials case report forms.
Detailed description
This is a non-interventional, observational, multicenter and retrospective study that will not under any circumstances interfere in the physician's normal clinical practice. Being limited to the collection of patient data already filled in the Tumor Thoracic Registry (TTR) data base and the data from stage IIIA clinical trials case report forms, it does not entail any diagnostic or therapeutic procedure outside of normal clinical practice.
The primary objective is to assess pathological response after neoadjuvant treatment as a subrogate endpoint for overall survival and disease-free survival in resectable stage IIIA non-small cell lung cancer patients.
It is estimated that around 15-20 Spanish sites are enrolling patients with these characteristics in the TTR or in the stage IIIA clinical trials of the Fundación GECP.
Pathologists and physician's of these sites will be invited to participate in the PLANET study as all cases will be clinical-pathologically re-evaluated to reach the study objectives. Each pathologist will re-evaluate the specimens from the selected patients under common criteria.The sample size would be 150 patients enrolled in the study.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: platinum-based neoadjuvant treatment and surgery. | – | Drug: Cisplatin, Drug: CarboplatinResectable stage IIIA non-small cell lung cancer patients treated with platinum-based neoadjuvant treatment and surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include all resectable stage IIIA patients who have received platinum-based neoadjuvant treatment and surgery and that were diagnosed as stage IIIA from 2010 to 2017.The cohort of patients identified for the current study will be based on a portion of patients included in the Thoracic Tumor Registry (TTR) and in stage IIIA clinical trials approved by Spanish Health Authorities which the sponsor is Fundación GECP.
Key inclusion criteria (6 listed)
- Patients with resectable stage IIIA disease (according to American Joint Committee on Cancer [AJCC] lung cancer edition 7 or 8) who were included in the Tumor Thoracic Registry data base and in stage IIIA clinical trials which the sponsor is Fundación GECP.
- Patients with histologically N2 involvement confirmed
- Patients diagnosed as stage IIIA from 2010 and 2017
- Patients who have received neoadjuvant platinum-based treatment and surgery
- Age ≥ 18 years at time of study entry
Key exclusion criteria (3 listed)
- Patients who received chemoradiotherapy neoadjuvant treatment
- Patients who were not resected after neoadjuvant treatment
- Patients who were diagnosed after June 2017
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 |
|---|---|---|
| CisplatinAlso: Cis-diammine-dichloroplatinum, PlatinolRoute of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery. | Drug | Experimental: platinum-based neoadjuvant treatment and surgery. |
| CarboplatinAlso: ParaplatinRoute of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery. | Drug | Experimental: platinum-based neoadjuvant treatment and surgery. |
Primary outcome
To assess pathological response after neoadjuvant treatment as a subrogate endpoint for overall survival and disease-free survival in resectable stage IIIA non-small cell lung cancer patients.
Time frame: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months
Pathological response will be assessed as complete pathological response, major pathological response (defined as ≤10% of viable tumor cells) and incomplete pathological response.
4 secondary outcomes
To describe the percentage of residual viable tumor in this population of patients under common criteria
Time frame: From the end of neoadjuvant treatment until the last follow up or death,assessed up to 45 months
To describe the histopathological changes within tumor bed associated to tumor response
Time frame: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months
To correlate pathological response and post-surgical complications
Time frame: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months
To describe the relation between nodal downstaging after neoadjuvant treatment and overall survival
Time frame: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 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 6 Feb 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
President of Grupo Español de Cáncer de Pulmón
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage IIIA Non-small Cell Lung Cancer, run by Fundación GECP at 17 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 6 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 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
To assess pathological response after neoadjuvant treatment as a subrogate endpoint for overall survival and disease-free survival in resectable stage IIIA non-small cell lung cancer patients. (time frame: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months). 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 6 Feb 2026.