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New treatment option for Non Small Cell Lung Cancer Metastatic
Official title PALACE: Cemiplimab Trial According to ctDNA Levels
ClinicalTrials.gov ID: NCT06917573
What this study is testing
What is Cemiplimab?
Cemiplimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non small cell lung cancer metastatic.
Also referred to as REGN2810.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, non-randomised, phase II, multicenter clinical trial. 63 stage IV or stage IIIB/C not candidates for definitive chemo/radiotherapy or surgical resection non-small cell lung cancer (NSCLC) per the 8th edition TNM with no prior systemic anti-cancer therapy will be enrolled in this trial to determine whether therapy decision making based on ctDNA analysis improves overall survival.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
- 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 confirmed stage IV or stage IIIB/C not candidates for definitive chemo/radiotherapy or surgical resection non-small cell lung cancer...
- PDL1 ≥50%
- ECOG performance status 0-1
- Patients aged ≥ 18 years
- Prior adjuvant or neoadjuvant chemotherapy for early stage is permitted if completed at least 6 months prior to enrolment
You likely can't join if
- Patients whose tumors harbor an activating mutation in EGFR, ALK translocation, or ROS Proto-Oncogene 1 (ROS1) rearrangements sensitive to available...
- Patients with grade ≥2 neuropathy
- Pregnant or breastfeeding women
- Patients with a weight loss \>10% within the previous 3 months
- Patients with carcinomatous meningitis
- Patients with a history of other malignant diseases within the past 3 years
See the full eligibility criteria
- Histologically confirmed stage IV or stage IIIB/C not candidates for definitive chemo/radiotherapy or surgical resection non-small cell lung cancer (NSCLC) per the 8th edition TNM with no prior systemic anti-cancer...
- PDL1 ≥50%
- ECOG performance status 0-1
- Patients aged ≥ 18 years
- Prior adjuvant or neoadjuvant chemotherapy for early stage is permitted if completed at least 6 months prior to enrolment
- Presence of at least one measurable lesion by CT-scan per RECIST version 1.1
- Anticipated life expectancy \>12 weeks
- Correct hematological, hepatic and renal function
- Patient consent must be obtained in the appropriate manner as established in the applicable local and regulatory requirements
- Patients must be accessible for treatment and follow-up
- Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 3 days before enrolment.
- All sexually active men and women of childbearing potential must use a highly effective contraceptive method during the study treatment and for a period of at least 4 months following the last administration of trial...
- Patients whose tumors harbor an activating mutation in EGFR, ALK translocation, or ROS Proto-Oncogene 1 (ROS1) rearrangements sensitive to available targeted inhibitor therapy
- Patients with grade ≥2 neuropathy
- Pregnant or breastfeeding women
- Patients with a weight loss \>10% within the previous 3 months
- Patients with carcinomatous meningitis
- Patients with a history of other malignant diseases within the past 3 years
- Patients must have recovered from a major surgery at least 14 days prior to enrolment
- Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol
- Prior treatment with antineoplasic drugs or thoracic radiotherapy for any reason different from the ones specific in the inclusion criteria
- Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemo-radiotherapy with curative intent for non-metastatic disease less than 6 months before enrollment since the last chemotherapy...
- Patients with a combination of small cell lung cancer and non-small cell lung cancer, a carcinoid lung tumor or large cell neuroendocrine carcinoma
- Has known allergy or hypersensitivity to components of study drug
- Significant comorbidities that preclude the administration of chemotherapy according to the investigator's criteria
- Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
- Untreated brain metastasis(es) that may be considered active
- Immunosuppressive corticosteroid doses within 4 weeks prior to the first dose of cemiplimab
- Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiency virus; or diagnosis of immunodeficiency
- History of interstitial lung disease or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.
- History of documented allergic reactions or acute hypersensitivity reactions attributed to antibody treatments
- Patients with a history of solid organ transplant
- Receipt of live vaccines within 30 days of first study treatment
- Women of childbearing potential, or sexually active men, who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment prior to the start of the first treatment...
The study team makes the final eligibility decision.
Where it's taking place
- Alicante, Alicante, Spain
- Elche, Alicante, Spain
- Badalona, Barcelona, Spain
- Barcelona, Barcelona, Spain
- L'Hospitalet de Llobregat, Barcelona, Spain
- Bilbao, Bilbao, Spain
- Jerez de la Frontera, Cádiz, Spain
- Girona, Girona, Spain
- A Coruña, La Coruña, Spain
- Las Palmas de Gran Canaria, Las Palmas, Spain
- Leganés, Madrid, Spain
- Madrid, Madrid, Spain
- Palma de Mallorca, Mallorca, Spain
- Málaga, Málaga, Spain
- Palma de Mallorca, Palma de Mallorca, Spain
- Salamanca, Salamanca, Spain
- Valencia, Valencia, Spain
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 study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Alicante, Alicante, Spain; Elche, Alicante, Spain; Badalona, Barcelona, Spain; Barcelona, Barcelona, Spain; L'Hospitalet de Llobregat, Barcelona, Spain; Bilbao, Bilbao, Spain and 11 more location(s). 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.