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NCT Number: NCT05167487

Pathological Response After Neoadjuvant Treatment on NSCLC

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario De A Coruna, A Coruña, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Cisplatin

Drug

Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.

Other names: Cis-diammine-dichloroplatinum, Platinol

carboplatin

Drug

Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.

Other names: Paraplatin

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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

  2. 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

    Types of histopathological changes within tumor bed: fibrosis, lymphoid aggregates and others

  3. 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

    Pathological response will be assessed as complete pathological response, major pathological response (defined as ≤10% of viable tumor cells) and incomplete pathological response.

  4. 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

    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.

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

Retrospective Observational Study of Resectable Stage IIIA Non-small Cell Lung Cancer Patients: Pathological Response After Neoadjuvant Treatment and Patient Outcomes

Acronym: PLANET

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Dec 22, 2021
Registry last updated
Feb 6, 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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