Atezolizumab Plus Induction Chemotherapy Plus CT-radiotherapy. (APOLO) (NCT04776447) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Atezolizumab Plus Induction Chemotherapy Plus CT-radiotherapy. (APOLO)
Spain38 participantsStarted 2021-06-16
Plain-language summary
Open-label, non-randomized, phase II multi-centre controlled clinical trial.
51 non-resectable stage IIIA-IIIB non-small cell lung cancer patients will be enrolled in this trial to evaluate the efficacy of the treatment (Atezolizumab + Induction chemotherapy (CT) + CT-Radiotherapy) in terms of the Progression Free Survival at 12 months
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, aged ≥ 18 years old and ≤ 75 years.
* ECOG Scale (Eastern Cooperative Oncology Group) of performance status of 0 or 1.
* Histologically or cytologically confirmed, non-resectable Stage IIIA-IIIB NSCLC according to the 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology.
* PET-CT (Positron Emission Tomography -Computed tomography) and brain computed tomography or Magnetic resonance imaging (MRI) at baseline to confirm the absence of distant disease.
* Mediastinal involvement could be considered without histological confirmation when no margin can be distinguished in the lymph node mass.
* No prior treatment with anti-neoplastic drugs or thoracic radiotherapy for Stage IIIA-IIIB NSCLC.
* Patients who have received prior neo-adjuvant, adjuvant chemotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from enrollment since the last chemotherapy.
* Presence of at least one measurable disease by CT-SCAN, as defined by RECIST v1.1.
* Adequate hematologic and organ function defined by the following laboratory results obtained within 14 days prior to enrollment:
* Neutrophils ≥ 1500 cells/μL without granulocyte colony-stimulating factor support.
* Lymphocyte count ≥ 500/μL.
* Platelet count ≥ 100,000/μL without transfusion.
* Haemoglobin ≥ 10.0 g/dL. Patients may be transfused to meet this criterion.
* INR or aPTT ≤ 1.…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the efficacy of the treatment in terms of the Progression Free Survival (PFS) at 12 months
Timeframe: From the date of the end of treatment until 12 months