NCT06627738 Locally Advanced NSCLC Treated With Radiochemotherapy: Phase 2 Study on the Value of a Stereotactic Boost
| NCT ID | NCT06627738 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Centre Antoine Lacassagne |
| Condition | Carcinoma, Non-Small-Cell Lung |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-06-10 |
| Primary Completion | 2034-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 42 participants in total. It began in 2025-06-10 with a primary completion date of 2034-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06627738 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carcinoma, Non-Small-Cell Lung. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06627738 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06627738 currently recruiting?
Yes, NCT06627738 is actively recruiting participants. Contact the research team at DRCI-Promotion@nice.unicancer.fr for enrollment information.
Where is the NCT06627738 trial being conducted?
This trial is being conducted at Nice, France.
Who is sponsoring the NCT06627738 clinical trial?
NCT06627738 is sponsored by Centre Antoine Lacassagne. The trial plans to enroll 42 participants.