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 range18 Years – 75 Years
SexALL
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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.…
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