Atezolizumab Plus Induction Chemotherapy Plus CT-radiotherapy. (APOLO) (APOLO)
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|ClinicalTrials.gov Identifier: NCT04776447|
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : June 2, 2022
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
|Condition or disease||Intervention/treatment||Phase|
|Lung Diseases Carcinoma, Non-Small-Cell Lung Stage IIIA Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Respiratory Tract Neoplasms Carcinoma Bronchiogenic Stage III Thoracic Neoplasms||Drug: Carboplatin Drug: Placlitaxel Drug: Atezolizumab||Phase 2|
This is an open-label, non-randomized, phase II multi-centre controlled clinical trial.The total sample size is 51 patients. The population to be included are non-resectable stage IIIA-IIIB non-small cell lung cancer patients.
Patients randomised will receive induction treatment (Atezolizumab 1200mg+ Carboplatin AUC5+Paclitaxel 200 mg/m2 for 3 cycles) and concurrent chemotherapy (CT) -radiotherapy treatment for 3 cycles. At the end of concurrent treatment Atezolizumab 1200mg maintenance treatment will start and will be administered for 12 months (16 cycles).
The primary objective is to assess the efficacy of the treatment (Atezolizumab + Induction chemotherapy (CT) + CT-Radiotherapy) in terms of the Progression Free Survival (PFS) at 12 months according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
PFS are defined as the time from inclusion until objective tumor progression or death.
Patient accrual is expected to be completed within 2 years, treatment is planned to extend during 1.5 years and the patients will be followed up for 2 years. The study will end once survival follow-up has concluded.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Design: Open-label, non-randomized, phase II multi-centre controlled clinical trial.|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Atezolizumab Plus Induction Chemotherapy (CT) Plus Chemo-radiotherapy and Atezolizumab Maintenance Therapy in Non-resectable Stage IIIA-IIIB Non-small Cell Lung Cancer (NSCLC) Patients|
|Actual Study Start Date :||June 16, 2021|
|Estimated Primary Completion Date :||November 15, 2026|
|Estimated Study Completion Date :||November 15, 2027|
Experimental: Experimental: Atezolizumab plus induction chemotherapy plus CT-radiotherapy
Atezolizumab: 1200mg, IV infusion Carboplatin: AUC5, IV infusion Paclitaxel: 200 mg/m2 The treatment will start within 1-5 days from enrollment. The treatment will be 3 cycles administered at 21-day intervals.
Concurrent Chemotherapy (CT)-Radiotherapy Treatment:
Chemotherapy and radiotherapy treatment will be at the discretion of the principal investigator of each site. It is recommended to use as concurrent chemotherapy treatment a platinum based doublet.
After the 3rd cycle of the induction treatment, concurrent treatment will start, 1st concurrent cycle will be administered from day 1 of cycle 3 of induction treatment.
Concurrent chest radiotherapy will be administered starting at day 1 of cycle 1 of concurrent chemo-radiotherapy.
Maintenance with Atezolizumab:
Atezolizumab: 1200mg, IV infusion After the 3rd cycle of the concurrent treatment, Atezolizumab maintenance treatment will start from day 1 of cycle 6 and will be administered for 12 months.
Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) plating. Stability: 24 hours at ambient temperature in 5% glucose, glucosamine or physiologic saline. It is recommended not to dilute with chlorinated solutions for this could affect the carboplatin.
Route of administration: Intravenous infusion.
Guidelines of Carboplatin administration: According to the standard of each center.
Other Name: ATC code: L01XA02
Other Name: Carboplatinum
Structure: A diterpene whose composition is: 5b, 20-epoxy-1, 2a, 4,7b, 10b, 13a-hexahidroxytax-11-en 9 one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)- N-benzoyl-3-phenylisoserine.
Stability: Concentrations of 0.3-1.2 mg/ml in 5% dextrose or normal saline have demonstrated chemical and physical stability for more than 27 hours at ambient temperature (25ºC approximately). The intact vial must be stored between 15º and 25ºC.
Guidelines of Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml.
Other Name: Taxol
Atezolizumab is a humanized immunoglobulin (IgG1) monoclonal antibody that is produced in Chinese hamster ovary (CHO) cells. Atezolizumab targets programmed death-ligand 1 (PD-L1) on tumor-infiltrating immune cells (ICs) or tumor cells (TCs) and prevents interaction with the programmed death-1 (PD-1) receptor and B7.1 (CD80), both of which function as inhibitory receptors expressed on T cells and other immune cells.
Patients will receive 1200 mg of atezolizumab administered by IV infusion every 21 days (+/- 3 days) in a monitored setting where there is immediate access to trained personnel and adequate equipment/medicine to manage potentially serious reactions.
Other Name: Tecentriq
- To assess the efficacy of the treatment in terms of the Progression Free Survival (PFS) at 12 months [ Time Frame: From the date of the end of treatment until 12 months ]To assess the efficacy of the treatment (Atezolizumab + Induction chemotherapy (CT) + CT-Radiotherapy) in terms of the Progression Free Survival (PFS) at 12 months according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.PFS is defined as the time from inclusion until objective tumor progression or death.
- To evaluate the Overall Response Rate (ORR) of the treatment [ Time Frame: From the date of randomization to the date of last follow up, assessed up to 36 months ]To evaluate the ORR of the treatment as measured by investigator-assessed overall response rate (ORR) according to RECIST v1.1.
- To evaluate the Overall survival (OS) rate [ Time Frame: From the date of the end of treatment until 12 and 24 months ]To evaluate the Overall survival (OS) rate at 12 and 24 months of the treatment.
- To evaluate the sites of first failure [ Time Frame: From the date of the end of treatment until the date of last follow up, assessed up to 36 months ]To evaluate the sites of first relapse or progression
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: From the subject's written consent to participate in the study through 30 days after the final administration of the drug ]Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04776447
|Contact: Eva Pereiraemail@example.com|
|Study Chair:||Mariano Provencio, MD||Fundación GECP President|