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Immunotherapy

Phase 2

Stage III Non-small Cell Lung Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Dec 17, 2025

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

Clinical trial landscape

Immunotherapy · 1 trial · 3 indications

Phase 2 1
NCT06102057PACCELIO - FDG-PET Based Small Volume Accelerated Immuno Chemoradiotherapy in Locally Advanced NSCLCStage III Non-small Cell Lung Cancer
RECRUITING110 Analytics
PHASE2RECRUITING
PACCELIO - FDG-PET Based Small Volume Accelerated Immuno Chemoradiotherapy in Locally Advanced NSCLC
Stage III Non-small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Comparison of the Completion rate of Experimental Arm to Conventional Arm
approximately 22 weeks after start of radio-chemotherapy

To assess the feasibility of an FDG-PET-based small volume accelerated chemoradiotherapy followed by immunotherapy with durvalumab compared to standard FDG-PET-based chemoradiotherapy followed by immunotherapy with durvalumab Completion rate defined as rate of patients having received: * the prescribed radiotherapy dose ± 2 fractions and * simultaneous platinum-based chemotherapy and · immunotherapy consolidation with durvalumab starting within 42 days after the last dose of chemoradiotherapy and * either at least 3 doses of durvalumab or less than 3 doses of durvalumab in case immunotherapy was permanently discontinued due to documented extrathoracic immune-related toxicity.

Secondary Endpoints

Comparison of the Occurrence of adverse events and serious events of Experimental Arm to Conventional Arm
up to 78 weeks
Comparison of the Time to locoregional progression of Experimental Arm to Conventional Arm
time from randomization to progression in the primary tumor or any of mediastinal lymph nodes, up to 143,5 weeks
Comparison of the Time to locoregional in-RT-field progression of Experimental Arm to Conventional Arm
time from rando to progression in primary tumor or mediastinal lymph nodes within the target volume, up to 143,5 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Conventional ArmACTIVE_COMPARATORstandard FDG-PET-based radiotherapy with concurrent standard of care chemotherapy
Experimental ArmEXPERIMENTALFDG-PET-based small volume accelerated radiotherapy with concurrent standard of care chemotherapy

Interventions

NameTypeDescription
standard RadiotherapyRADIATIONstandard FDG-PET-based radiotherapy
ChemotherapyDRUGconcurrent standard of care chemotherapy
ImmunotherapyDRUGstandard of care consolidation therapy with durvalumab (fixed dose of 1500 mg q4w) for up to 12 months or until progression of disease, unacceptable toxicity, patient´s wish, or investigator´s decision, whichever comes first.
Experimental RadiotherapyRADIATIONFDG-PET-based small volume accelerated radiotherapy
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Written informed consent * Patients irrespective of sex and gender, aged 18 years or older at the time of signing the ICF * Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study as determi...

Countries:GermanySwitzerland
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Frequently asked questions about Immunotherapy

What is Immunotherapy used for in Stage III Non-small Cell Lung Cancer?

Immunotherapy is an investigational small molecule being studied for the treatment of Stage III Non-small Cell Lung Cancer, specifically in patients with locally advanced, unresectable disease. It is currently in Phase 2 clinical development and is being evaluated as part of a combination regimen with chemo-radiotherapy.

Who is developing Immunotherapy?

Immunotherapy is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting a Phase 2 clinical trial to evaluate this investigational treatment in patients with Stage III Non-small Cell Lung Cancer.

What phase is Immunotherapy in?

Immunotherapy is currently in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is actively recruiting participants to evaluate its safety and efficacy in Stage III Non-small Cell Lung Cancer.

What clinical trials is Immunotherapy in?

Immunotherapy is being evaluated in a single Phase 2 clinical trial with the identifier NCT06102057. This trial, titled PACCELIO, is a randomized, active-controlled study investigating FDG-PET based small volume accelerated immuno chemoradiotherapy in locally advanced NSCLC. The trial is recruiting 110 participants in Germany and Switzerland.

How does Immunotherapy work?

Immunotherapy is a small molecule designed to modulate the immune system to fight cancer. While the specific molecular target has not been disclosed, it is being studied in combination with chemoradiotherapy to enhance the immune response against tumor cells in patients with Stage III Non-small Cell Lung Cancer.