Clinical trial · Interventional
Upfront Resection of Locally Advanced NSCLC Followed by Chemoradiotherapy
Upfront Resection of Locally Advanced NSCLC Followed by Chemoradiotherapy; Phase I Multicenter Study to Assess Treatment Feasibility and Safety
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
For patients with irresectable locally advanced non-small cell lung cancer (NSCLC) (e.g. multilevel or bulky N2 disease or presence of N3 lymph node metastases), current guidelines recommend treatment with chemoradiotherapy (CRT) followed by immune checkpoint inhibition (ICI, durvalumab). Chances of sterilization of a large (e.g. clinically staged T3 or T4 tumor) tumor volume by CRT alone are relatively small and these tumors are associated with a high local recurrence rate. Moreover, necrosis and cavitation of these tumors puts these patients at risk of fatal bleeding and might cause infectious complications, which lead to subsequent impaired quality of life (QoL) and to interruption of, or the need for postponing, (systemic) treatment. Upfront resection of the tumor in the lung, followed by postoperative CRT in patients who have a (potentially) resectable tumor could be a strategy to prevent complications of CRT in large volume and/or cavitating tumors with extensive mediastinal disease.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cavitation Lung | — | UNRESOLVED | — |
| Chemoradiotherapy | — | UNRESOLVED | — |
| Feasibility | — | UNRESOLVED | — |
| Locally Advanced Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Safety | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Upfront resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study population
- description
- All included patients will have an upfront surgery of the primary tumor, followed by chemoradiotherapy. Resection will be done within 2-4 weeks after presentation in the multidisciplinary team meeting (MDT). After resection, restaging will take place preceding start of CRT, which should start within 4-6 weeks after resection.
- interventionNames
- Procedure: Upfront resection
Primary outcomes (1)
- measure
- Intervention Feasibility
- timeFrame
- 2 years
- description
- Assessed by the number of patients completing the predefined treatment. Feasibility is proven if at least 15 out of 20 patients complete the treatment protocol consisting of upfront resection and chemoradiotherapy.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Provision of signed, written and dated IC prior to any study specific procedures. * Male or female aged at least 18 years. * Eastern Cooperative Oncology Group (ECOG)/WHO performance status of 0 or 1. * A pretreatment PET/CT scan (of the thorax and upper abdomen) and an MRI (or CT scan) of the brain is considered SoC and must be done prior to start of treatment. * Pathologically proven NSCLC, staged according to the 8th edition of the AJCC Staging Manual, with a clinical indication for concurrent CRT (according to current guidelines). * Pathology proven N2 or N3 lymph node metastasis. * Patients should be able to receive concurrent CRT. * Patients should be operable to the discretion of the treating pulmonary physician, surgeon and anesthesiologist, based on lung function testing and performance scoring. * EGFR/ALK mutations and never-smokers may be included in the study (since endpoints are settled after finishing CRT and before starting adjuvant systemic treatment). Exclusion Criteria: * Irresectable primary lung tumor before start of concurrent CRT. * Pneumonectomy deemed necessary (by the treating surgeon) to achieve a complete resection (R0). * Sulcus superior tumor with invasion of the thoracic wall. * cT3-4 based on satellite nodus/lesion in the ipsilateral lung. * Patients with a locoregional recurrence or a second primary lung cancer. * Patients with prior treatment with radiotherapy on the lung. * Patients with a history of other malignancies, except: * adequately treated non-melanoma skin cancer * curatively treated in-situ cancer, or * other malignancies curatively treated with no evidence of disease for \>5 years following the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy. * Small cell lung cancer or a pulmonary carcinoid tumor.
References
Publications (0)
Data not yet available