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New treatment option for Non Small Cell Lung Cancer
Official title Neoadjuvant Treatment With Atezolizumab and Atezolizumab as Maintenance for the Treatment of Stage III Non Small-Cell Lung Cancer (NSCLC)
ClinicalTrials.gov ID: NCT07153445
What this study is testing
What is Atezolizumab?
Atezolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non small cell lung cancer.
Also referred to as Tecentriq.
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, phase II, multi-centre clinical trial. 97 Patients with stage IIIA and IIIB non-small cell lung cancer will be enrolled.
- Phase 2: a mid-size study of how well it works
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
- Previously untreated patients with histologically- or cytologically- documented Non Small-Cell Lung Cancer (NSCLC) who present stage IIIA - IIIB...
- Confirm the absence of distant disease
- ECOG (Performance status) 0-1
- Adequate hematologic and organ function
- All patients are notified of the investigational nature of this study and signed a written in-formed consent in accordance with institutional and...
You likely can't join if
- Patients mutation or an amplification in the EGFRgene, ALK fusion oncogene.
- Known STK-11 ligand alterations, MDM2 amplifications or ROS1 translocations.
- Weight loss \>10% within the previous 3 months.
- Patients that receive previous treatment with antineoplasic drugs, chest radiotherapy, or previous surgery for lung cancer.
- Malignancies other than Non Small-Cell Lung Cancer (NSCLC) within 3 years prior to enrolment
- Pleural or pericardial effusion
See the full eligibility criteria
- Previously untreated patients with histologically- or cytologically- documented Non Small-Cell Lung Cancer (NSCLC) who present stage IIIA - IIIB disease (according to 8th version of the International Association for the...
- Confirm the absence of distant disease
- ECOG (Performance status) 0-1
- Adequate hematologic and organ function
- All patients are notified of the investigational nature of this study and signed a written in-formed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any...
- Adequate lung function
- Patients aged \> 18 years
- For female patients of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception
- For male patients with female partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form of contraception
- Oral contraception should always be combined with an additional contraceptive method
- Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within 8 days prior to initiation of study drug.
- Patient capable of proper therapeutic compliance and accessible for correct follow-up
- Patients mutation or an amplification in the EGFRgene, ALK fusion oncogene.
- Known STK-11 ligand alterations, MDM2 amplifications or ROS1 translocations.
- Weight loss \>10% within the previous 3 months.
- Patients that receive previous treatment with antineoplasic drugs, chest radiotherapy, or previous surgery for lung cancer.
- Malignancies other than Non Small-Cell Lung Cancer (NSCLC) within 3 years prior to enrolment
- Pleural or pericardial effusion
- Known hypersensitivity or allergy to atezolizumab formulation.
- History of autoimmune disease or lung disease
- Positive test for human immunodeficiency viruses (HIV)
- Patients with active hepatitis B or hepatitis C or psitive for hepatitis C virus.
- Active tuberculosis.
- Symptomatic neuropathy grade \> 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
- Severe infections within 4 weeks prior to be included in the study
The study team makes the final eligibility decision.
Where it's taking place
- Alicante, Alicante, Spain
- Badalona, Barcelona, Spain
- Barcelona, Barcelona, Spain
- Bilbao, Bilbao, Spain
- Jerez de la Frontera, Cadiz, Spain
- Girona, Girona, Spain
- Granada, Granada, Spain
- A Coruña, La Coruña, Spain
- Las Palmas de Gran Canaria, Las Palmas, Spain
- Lugo, Lugo, Spain
- Madrid, Madrid, Spain
- Majadahonda, Madrid, Spain
- Palma de Mallorca, Palma de Mallorca, Spain
- Pamplona, Pamplona, Spain
- Salamanca, Salamanca, Spain
- Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain
- Seville, Sevilla, Spain
- Reus, Tarragona, 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 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 Alicante, Alicante, Spain; Badalona, Barcelona, Spain; Barcelona, Barcelona, Spain; Bilbao, Bilbao, Spain; Jerez de la Frontera, Cadiz, Spain; Girona, Girona, Spain and 13 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.