Respiratory rehabilitation for quality of life in advanced NSCLC on maintenance chemo-immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study enrolls adults with histologically confirmed stage IV NSCLC who are on maintenance chemotherapy and pembrolizumab, to compare a structured respiratory rehabilitation program against standard care. It focuses on whether targeted breathing and endurance training can reduce symptoms and improve daily function and overall quality of life. The approach builds on evidence of benefit in other lung conditions, with limited data in advanced NSCLC. Outcomes center on quality of life, physical function, and safety in a maintenance-treatment setting. Locations include CHU Brest, CH Morlaix, and CH Cornouaille under the University Hospital, Brest.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically proven stage IV non-small cell lung cancer patient
* First-line treatment with chemotherapy combined with immunotherapy in the maintenance phase
* Adenocarcinoma patient: maintenance with Alimta combined with pembrolizumab
* Squamous cell carcinoma patient: maintenance with pembrolizumab alone
* Age of at least 18 years
* Performance status of 0 or 1
* Estimated life expectancy \> 12 weeks
* No contraindications to respiratory rehabilitation
* Adequate organ function, demonstrated by laboratory results within the last 3 weeks, allowing maintenance treatment:
* Normal liver function: bilirubin \< 1.5 x ULN, ALT and AST \< 2.5 x ULN or \< 5 x ULN in the case of liver metastases.
* Renal function (creatinine clearance calculation of at least \> 45 mL/min).
* Hematological function: absolute neutrophil count \> 1.5 x 10\^9/L and/or platelets \> 100 x 10\^9/L, hemoglobin \> 8 g/dL.
* Informed consent to participate in the study must be signed
* Patient must be affiliated with or beneficiary of social security

Exclusion Criteria:

* Small cell lung cancer, mesothelioma, neuroendocrine lung cancer
* Patients with orthopedic disorders preventing respiratory rehabilitation that, in the investigator's opinion, could interfere with respiratory rehabilitation
* Unresolved toxicity from previous treatment of grade \> 1 (except alopecia) that, in the investigator's opinion, could interfere with respiratory rehabilitation
* Symptomatic brain metastases (corticosteroid treatment is allowed if the doses administered are stable for at least one month before inclusion)
* Bone metastases preventing respiratory rehabilitation
* Contraindication to respiratory rehabilitation
* Uncontrolled infection
* Pregnancy and breastfeeding
* Surgery within two months prior to inclusion that could interfere with respiratory rehabilitation
* Persons under legal protection (guardianship or curatorship) or deprived of liberty

Where it's running

• CH Morlaix
  Morlaix, France Recruiting
• CH Cornouaille
  Quimper, France Recruiting
• CHU Brest
  Brest, France Not yet recruiting

Study contacts

• Study coordinator: Florence Jacquemine Péguet-Ménard
• Email: jacquemine.menard@chu-brest.fr
• Phone: 06.23.25.64.50

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.