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A phase II trial of Atezolizumab plus induction chemotherapy (CT) plus chemo-radiotherapy and Atezolizumab maintenance therapy in non-resectable stage IIIA-IIIB-IIIC non-small cell lung cancer (NSCLC) patients (APOLO)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514803-33-00
Enrollment
51
Registered
2024-07-15
Start date
2021-06-16
Completion date
2025-07-31
Last updated
2025-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer (NSCLC)

Brief summary

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.

Detailed description

"1. To evaluate the ORR of the treatment as measured by investigator-assessed overall response rate (ORR) according to RECIST v1.1.", 2. To evaluate the PFS rate at 24 months of the treatment., 3. To evaluate the Overall survival (OS) rate at 12 and 24 months of the treatment., 4. To evaluate the sites of first failure, 5. To evaluate the safety and tolerability of Atezolizumab in combination with chemotherapy and Atezolizumab as maintenance treatment.

Interventions

DRUGTecentriq 1 200 mg concentrate for solution for infusion

Sponsors

Fundacion GECP
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
"1. To evaluate the ORR of the treatment as measured by investigator-assessed overall response rate (ORR) according to RECIST v1.1.", 2. To evaluate the PFS rate at 24 months of the treatment., 3. To evaluate the Overall survival (OS) rate at 12 and 24 months of the treatment., 4. To evaluate the sites of first failure, 5. To evaluate the safety and tolerability of Atezolizumab in combination with chemotherapy and Atezolizumab as maintenance treatment.

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026