Upfront Resection of Locally Advanced NSCLC Followed by Chemoradiotherapy

NCT05620199 | Unknown

• 1 other identifier: M22UPL
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Locally Advanced Non-Small Cell Lung Cancer; Chemoradiotherapy; Cavitation Lung; Surgery; Feasibility; Safety

Outcome Measures

Primary Outcomes (1)

• Intervention Feasibility

  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.

  2 years

Secondary Outcomes (2)

• Intervention Safety

  2 years

• Complications

  2 years

Study Arms (1)

Study population

EXPERIMENTAL

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.

Procedure: Upfront resection

Interventions

Upfront resection PROCEDURE

Resection of the primary tumor

Study population

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Leiden University Medical Center: collaborator
• Radboud University Medical Center: collaborator
• University Medical Center Groningen: collaborator
• Erasmus Medical Center: collaborator
• Maastricht University Medical Center: collaborator
• Zuyderland Medical Centre: collaborator
• Maxima Medical Center: collaborator

Study Officials

• Koen Hartemink, MD, PhD

  The Neterlands Cancer Institute (NKI), Antoni van Leeuwenhoek

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Luger, Bsc.

CONTACT

+31657341946; r.luger@nki.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: April 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: March 20, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share