Pathological Response After Neoadjuvant Treatment on NSCLC (PLANET)

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.

Study Overview

• Status: Recruiting
• Conditions: Stage IIIA Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Cisplatin; Drug: Carboplatin

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Eva Pereira; Phone Number: +34934302006; Email: gecp@gecp.org

Study Locations

• Spain
  • A Coruña
    • A Coruña, A Coruña, Spain, 15006
      • Recruiting
      • Hospital Universitario de A Coruña
      • Contact: Teresa Hermida, MD
      • Principal Investigator: Teresa Hermida, MD
  • Alicante
    • Alicante, Alicante, Spain, 03010
      • Recruiting
      • Hospital General Universitario de Alicante
      • Contact: Ignacio Aranda, MD
      • Principal Investigator: Ignacio Aranda, MD
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Recruiting
      • ICO Badalona, Hospital Germans Trias i Pujol
      • Contact: José Luis Mate, MD
      • Principal Investigator: José Luis Mate, MD
    • Barcelona, Barcelona, Spain, 08035
      • Recruiting
      • Hospital Vall d'Hebron
      • Contact: Irene Sansano, MD
      • Principal Investigator: Irene Sansano, MD
    • Barcelona, Barcelona, Spain, 08041
      • Recruiting
      • Hospital De La Santa Creu I Sant Pau
      • Contact: Laura López Vilaró, MD
      • Principal Investigator: Laura López Vilaró, MD
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
      • Recruiting
      • ICO Hospitalet
      • Contact: Nuria Baixeras, MD
      • Principal Investigator: Nuria Baixeras, MD
  • Gran Canaria
    • Las Palmas de Gran Canaria, Gran Canaria, Spain, 35016
      • Recruiting
      • Hospital Universitario Insular de Gran Canaria
      • Contact: Maria del Carmen Camacho, MD
      • Principal Investigator: Maria del Carmen Camacho, MD
  • Las Palmas
    • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
      • Recruiting
      • Hospital Dr. Negrín
      • Contact: María Luz Plaza, MD
      • Principal Investigator: María Luz Plaza
  • Madrid
    • Madrid, Madrid, Spain, 28040
      • Recruiting
      • Hospital Clinico San Carlos
      • Contact: Melchor Saiz Pardo, MD
      • Principal Investigator: Melchor Saiz Pardo, MD
    • Madrid, Madrid, Spain, 28046
      • Recruiting
      • Hospital Universitario La Paz
      • Contact: Isabel Esteban, MD
      • Principal Investigator: Isabel Esteban, MD
    • Madrid, Madrid, Spain, 28041
      • Recruiting
      • Hospital 12 de Octubre
      • Contact: Ana Belén Enguita, MD
      • Principal Investigator: Ana Belén Enguita, MD
    • Madrid, Madrid, Spain, 28040
      • Recruiting
      • Hospital Universitario Fundacion Jimenez Diaz
      • Contact: Federico Rojo, MD
      • Principal Investigator: Federico Rojo, MD
    • Majadahonda, Madrid, Spain, 28222
      • Recruiting
      • Hospital Universitario Puerta de Hierro
      • Contact: Mariano Provencio, MD
      • Principal Investigator: Clara Salas, MD
  • Málaga
    • Málaga, Málaga, Spain, 29010
      • Recruiting
      • Hospital Universitario Regional de Málaga
      • Contact: Pino Flores, MD
      • Principal Investigator: Pino Flores, MD
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36036
      • Recruiting
      • Complejo Hospitalario Universitario de Vigo
      • Contact: Ana González, MD
      • Principal Investigator: Ana González, MD
  • Valencia
    • Valencia, Valencia, Spain, 46026
      • Recruiting
      • Hospital Universitario La Fe
      • Contact: Nuria Mancheño, MD
      • Principal Investigator: Nuria Mancheño, MD
  • Vizcaya
    • Barakaldo, Vizcaya, Spain, 48903
      • Recruiting
      • Hospital Universitario Cruces
      • Contact: Mónica Saiz, MD
      • Principal Investigator: Mónica Saiz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients who received chemoradiotherapy neoadjuvant treatment
• Patients who were not resected after neoadjuvant treatment
• Patients who were diagnosed after June 2017

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental: platinum-based neoadjuvant treatment and surgery.; Resectable stage IIIA non-small cell lung cancer patients treated with platinum-based neoadjuvant treatment and surgery.	Drug: Cisplatin; Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.; Other Names: Platinol; Cis-diammine-dichloroplatinum; Drug: Carboplatin; Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.; Other Names: Paraplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe the percentage of residual viable tumor in this population of patients under common criteria	A) 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	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	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.	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.	From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months

Collaborators and Investigators

• Sponsor: Fundación GECP
• Investigators: Study Chair: Mariano Provencio, MD, President of Grupo Español de Cáncer de Pulmón

Publications and helpful links

Helpful Links

• Web page of the sponsor where users can find more information about Fundación GECP studies

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Observational study; Non small cell lung cancer; Pathological response; Neoadjuvant Treatment; Resectable IIIA patients
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Organic Chemicals; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Platinum Compounds; Carboplatin; Cisplatin
• Other Study ID Numbers: GECP 21/03_PLANET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No