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

NCT06627738 | Recruiting Phase 2

• 2 other identifiers: 2022/172024-A01394-43
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Evaluate overall survival at 24 months and at 60 months

  60 months

• Evaluate specific survival at 24 months and at 60 months

  60 months

• Evaluate the efficacy of the additional Cyberknife irradiation following concomitant radio-chemotherapy at 24 months

  24 months

• Evaluate overall tolerability of the additional Cyberknife irradiation following concomitant radio-chemotherapy at 24 months

  24 months

• Evaluate overall quality of life before Cyberknife, 1 month post-Cyberknife and 6 months post-Cyberknife

  6 months

Study Arms (1)

Experimental Arms

EXPERIMENTAL

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

Interventions

Cyberknife irradiation RADIATION

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

Experimental Arms

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 years old or more
• ECOG 0 to 2
• Histologically proven non-small cell lung cancer
• Stage III non-metastatic tumor, not allowing for immediate surgery
• Volume(s) on the evaluation chest CT scan done at the end of conventional radiotherapy (between 34 \& 46 Gy) meeting the following criteria:
• 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
• 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)
• No contraindication to implantable venous devices (IVDs)
• Patient who has read the patient information note and signed the consent form
• If applicable, negative pregnancy test\*
• Eligible for National Health Insurance in France
• Chest CT scan performed prior to Taxcis

You may not qualify if:

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

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06000, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study coordinator

CONTACT

+33 04 92 03 16 61; DRCI-Promotion@nice.unicancer.fr

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: October 3, 2024
• First Posted: October 4, 2024
• Study Start: June 10, 2025
• Primary Completion (Estimated): February 1, 2034
• Study Completion (Estimated): February 1, 2034
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

FR (1)