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Official title Impact of Respiratory Rehabilitation on Quality of Life in Patients With Metastatic Non-small Cell Lung Cancer Treated With Immunotherapy and Chemotherapy in the Maintenance Phase
ClinicalTrials.gov ID: NCT06441773
What this study is testing
- What it's testing
- Lung cancer is highly prevalent, with approximately 46,363 new cases in 2018, accounting for 20.6% of cancer deaths in France. At diagnosis, 70% of patients have advanced or metastatic cancer, treatable only by palliative care.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Unresolved toxicity from previous treatment of grade \> 1 (except alopecia) that, in the investigator's opinion, could interfere with respiratory...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brest, France
- Morlaix, France
- Quimper, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brest, France; Morlaix, France; Quimper, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.