Atezolizumab Plus 8 Gy Single-fraction Radiotherapy for Advanced Oligoprogressive NSCLC

NCT04549428 | Terminated Phase 2

• 1 other identifier: IOSI-LUNG-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

Multicentre, phase II, open-label, single-arm study evaluating the preliminary efficacy, safety and tolerability of atezolizumab in association with palliative radiotherapy in adult patients diagnosed with advanced (stage IV) NSCLC, irrespective of PD-L1 status, and who have oligoprogressed to both immunotherapy with an anti PD-1 agent (e.g., pembrolizumab or nivolumab) and 1 line of chemotherapy.

Conditions

NSCLC Stage IV

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Percentage of patients with a complete response or partial response

  3 months

Secondary Outcomes (2)

• Overall Survival

  12 months

• Progression Free-Survival

  12 months

Study Arms (1)

Atezolizumab

EXPERIMENTAL

Atezolizumab will be administered at a fixed dose of 1,200 mg by intravenous infusion every 21 days on an outpatient basis until progression, intolerance or loss of clinical benefit, according to the its approved prescribing information. Palliative radiation therapy will be delivered concomitant to the 2nd dose of atezolizumab as a single fraction of 8 Gy

Drug: Atezolizumab

Interventions

Atezolizumab DRUG

Intravenous infusion every 21 days, until disease progression, intolerance or loss of clinical benefit.

Also known as: Tecentriq

Atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form
• Male or female aged ≥ 18 years
• Ability to comply with the procedures of the study protocol, in the investigator's judgment
• Histologically or cytologically confirmed diagnosis of metastatic (Stage IV) NSCLC as per the American Joint Committee on Cancer (AJCC) 8th edition
• No sensitizing EGFR mutation (L858R or exon 19 deletions), ALK fusion oncogene or ROS1 rearrangement detected
• Progressing to one line of chemotherapy defined as follows:a) A platinum-doublet.

You may not qualify if:

• c) As an exception, patients with oligoprogression to anti PD-1 agents alone for whom the investigator considers local treatment of metastases and continuation of immunotherapy appropriate (i.e. would not be eligible for 2nd line treatment) may be enrolled without a previous line of chemotherapy. In this case, approval by the Project Leader is necessary.
• Progressing to an anti-PD-1 agent, either associated to chemotherapy or as monotherapy (e.g., pembrolizumab or nivolumab)
• Life expectancy ≥ 8 weeks
• Patients with treated, asymptomatic central nervous system (CNS) metastases are eligible, provided they meet all of the following criteria:
• Measurable disease outside CNS.
• Only supratentorial and cerebellar metastases allowed (i.e., no metastases to midbrain, pons, medulla or spinal cord).
• No ongoing requirement for corticosteroids as therapy for CNS disease; anticonvulsants at a stable dose allowed.
• No stereotactic radiation within 7 days or whole-brain radiation within 14 days prior to initiating study treatment.
• No evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study.
• Patients with new asymptomatic CNS metastases detected at the screening scan must receive radiation therapy and/or surgery for CNS metastases. Following treatment, these patients may then be eligible without the need for an additional brain scan prior to initiating study treatment, if all other criteria are met, including clinical confirmation of no evidence of interim disease progression
• Measurable disease by RECIST v1.1. Previously irradiated lesions can only be considered as measurable disease if disease progression has been unequivocally documented at that site since radiation and the previously irradiated lesion is not the only site of disease.
• Oligoprogressive disease defined as follows:
• A minimum of 1 and a maximum of 4 progressing lesions (with up to 3 total organs and 3 lesions per organ, except skeletal lesions) as assessed by a Positron Emission Tomography-Computed Tomography (PET-CT) scan (contrast enhanced).
• Definition of progression is made by RECIST 1.1 criteria (new lesions or increased pre-existing ones).
• Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to initiating study treatment:

Sponsors & Collaborators

• Oncology Institute of Southern Switzerland: lead
• Ente Ospedaliero Cantonale, Bellinzona: collaborator
• Istituto Cantonale di Patologia: collaborator
• Clinical Trial Unit Ente Ospedaliero Cantonale: collaborator

Study Sites (3)

Oncology Institute of Southern Switzerland

Bellinzona, 6500, Switzerland

Location

Cantonal Hospital of Graubünden (KSGR)

Chur, 7000, Switzerland

Location

Geneva University Hospitals (HUG)

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Francesco Martucci, MD

  Oncology Institute of Southern Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 16, 2020
• Study Start: October 1, 2020
• Primary Completion: January 23, 2023
• Study Completion: May 31, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3)