Locally Advanced NSCLC Treated With Radiochemotherapy: Phase 2 Study on the Value of a Stereotactic Boost (Cybertaxcis II)

This is a monocentric, non-randomized, open-label, superiority phase II clinical investigation evaluating the efficacy of additional Cyberknife irradiation after a doublet of Platinum Salts-based chemotherapy and concomitant radiotherapy in patients with locally advanced non-small cell lung carcinoma (NSCLC), with an interim analysis.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Radiation: Cyberknife irradiation

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Study coordinator; Phone Number: +33 04 92 03 16 61; Email: DRCI-Promotion@nice.unicancer.fr

Study Locations

• France
  • Nice, France, 06000
    • Recruiting
    • Centre Antoine Lacassagne
    • Contact: Study coordinator; Email: DRCI-Promotion@nice.unicancer.fr
    • Principal Investigator: Pierre-Yves BONDIAU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients aged 18 years old or more
2. ECOG 0 to 2
3. Histologically proven non-small cell lung cancer
4. Stage III non-metastatic tumor, not allowing for immediate surgery

5. Volume(s) on the evaluation chest CT scan done at the end of conventional radiotherapy (between 34 & 46 Gy) meeting the following criteria:

   • 1 to 3 target volumes of less than 5 cm in greatest diameter
   • And allowing for the delivery of a CyberKnife boost to be carried out in compliance with the manufacturer requirements and with the doses delivered to the organs at risk (OAR/fractions) defined in appendix 2
6. Patients who have received a " Taxcis " treatment consisting in 2 cycles of induction chemotherapy (platinium-based doublet) and then at least 40 Gy of irradiation in combination with at least 2 cycles of concomitant chemotherapy (platinium-based doublet)
7. No contraindication to implantable venous devices (IVDs)
8. Patient who has read the patient information note and signed the consent form
9. If applicable, negative pregnancy test*
10. Eligible for National Health Insurance in France
11. Chest CT scan performed prior to Taxcis

Exclusion Criteria:

1. Positive EGFR mutation
2. Exercise-induced dyspnea associated with heart failure equal to or greater than stage III of the New York Heart Association (NYHA) classification, (appendix 3)
3. Coronary syndrome or heart failure in the last three months
4. Pulmonary function test contraindicating radiotherapy: PFT-FEV1 inferior to 1 L.
5. After radio-chemotherapy, presence of any toxicity contraindicating Cyberknife irradiation

6. Vulnerable populations and participants as defined in Articles 64 to 68 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017:

   • Incapacitated participants who have not given or refused informed consent prior to the onset of their incapacity, who are not under the provisions of article 64 ;
   • Pregnant or breast-feeding women who are not covered by the provisions of article 66 ;
   • Adults under legal protection or unable to express their consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arms; After their radiochemotherpy (Taxcis protocol), the eligible patients will be included in the study and will have a Cyberknife boost (5 sessions of 8 Gray, over 2 weeks maximum). They will have follow-up visits for 2 years post-treatment. Then, their disease and survival status will be recorded until 5 years post-treatment.	Radiation: Cyberknife irradiation; Additional Cyberknife irradiation after a doublet of Platinum Salts-based chemotherapy and concomitant radiotherapy in inoperable patients with locally advanced non-small cell lung carcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate progression-free survival at 24 months after additional Cyberknife irradiation following concomitant radio-chemotherapy in patients with locally advanced non-small cell lung carcinoma (NSCLC).	Progression-free survival at 24 months will be assessed by calculating the time between the date of inclusion and the date of progression (according to RECIST 1.1 criteria) or death from any cause whichever come first. Patients who have not progressed, died or been lost to follow-up at the time of analysis will be censored at the date of last news.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate overall survival at 24 months and at 60 months	Overall survival at 24 months and at 60 months will be assessed by calculating the time between the date of inclusion and the date of death from all causes. Patients who have not died or been lost to follow-up at the time of analysis will be censored at the date of last news.	60 months
Evaluate specific survival at 24 months and at 60 months	Specific survival at 24 months and at 60 months will be assessed by calculating the time between the inclusion and the date of cancer-related death. Patients who have not died or been lost to follow-up at the time of analysis will be censored at the date of last news.	60 months
Evaluate the efficacy of the additional Cyberknife irradiation following concomitant radio-chemotherapy at 24 months	The overall response rate (complete or partial response, stabilization, progression) at 24 months will be defined by RECIST v 1.1 criteria. The objective response rate (CR or PR) will be estimated as the number of patients with a documented complete or partial response, divided by the number of analyzable patients, described for each evaluation. The median duration of response will be given with its 95% confidence interval.	24 months
Evaluate overall tolerability of the additional Cyberknife irradiation following concomitant radio-chemotherapy at 24 months	The overall tolerability of the additional Cyberknife irradiation following concomitant radio-chemotherapy throughout patient participation will be evaluated by clinical and biological means and rated according to the NCI CTCAE V5.0 scale.	24 months
Evaluate overall quality of life before Cyberknife, 1 month post-Cyberknife and 6 months post-Cyberknife	Quality of life will be assessed using the EORTC QLQ-C30 questionnaire (items 29-30)	6 months

Collaborators and Investigators

• Sponsor: Centre Antoine Lacassagne

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2025
• Primary Completion (Estimated): February 1, 2034
• Study Completion (Estimated): February 1, 2034

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2022/17; 2024-A01394-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No