Stereotactic Body Radiotherapy for Oligo-Progression Metastatic Non-Small Cell Lung Cancer

NCT06523673 | Recruiting Phase 3 DMC

• 1 other identifier: OPPRESS
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if Stereotactic Body Radiotherapy (SBRT) can treat the oligo-progressive metastatic non-small cell lung cancer (NSCLC) after first-line chemotherapy. The main questions it aims to answer are: Does SBRT improve progression-free survival in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy? Does SBRT improve overall survival and quality of life in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy? Researchers will compare SBRT in combination with standard of care (SOC) and SOC only to see if SBRT works to treat oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy. Participants will: Take SBRT in combination with SOC or SOC only. Visit the clinic for checkups and tests as required by the study. Keep a diary of their symptoms and complete the quality of life assessment questionnaire.

Conditions

Metastatic Non-Small Cell Lung Cancer; NSCLC Stage IV; OligoProgressive Metastatic Disease

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  Progression-free survival, PFS: Time from date of randomization until the date of first documented progression or date of death from any cause after the second-line treatment, whichever came first.

  Time from date of randomization until the date of first documented progression or date of death from any cause after the second-line treatment, whichever came first, assessed up to 18 months.

Secondary Outcomes (3)

• Overall Survival (OS)

  Time from date of randomization to death (from any cause), assessed up to 36 months.

• Quality of Life (QoL)

  From enrollment to the end of survival follow-up at 36 months.

• Safety of SBRT

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

SBRT arm

EXPERIMENTAL

SBRT is administered to the site of progression. During SBRT treatment, maintenance therapy was with ICI or bevacizumab or combined single-agent chemotherapy. After the occurrence of progression that is no longer suitable for SBRT treatment, switch to second-line systemic therapy (same as SOC).

Radiation: Stereotactic Body Radiotherapy; Drug: second-line systemic therapy

SOC arm

ACTIVE COMPARATOR

Second-line systemic therapy is based on docetaxel or albumin-paclitaxel. The combination of immunotherapy or anti-vascular drugs is evaluated by the study physician. The specific drug regimen is determined in conjunction with the patient's wishes. Palliative radiotherapy is acceptable.

Drug: second-line systemic therapy

Interventions

Stereotactic Body Radiotherapy RADIATION

The dose of radiation therapy is determined by the radiologist based on the clinical parameters of the lesion, including tumor size and location. In most cases, radiotherapy fractionation regimens range from 27-30 Gy/3 Fractions or 30-50 Gy/5 Fractions, and appropriate radiotherapy doses covering 27-70 Gy/3-10 Fractions can also be selected by the radiologist based on radiation limitations of neighboring endangered organs.

Also known as: SBRT, Stereotactic Ablative Radiotherapy (SABR)

SBRT arm

second-line systemic therapy DRUG

a second-line docetaxel/albumin-bound paclitaxel-based systemic therapy regimen

Also known as: docetaxel-based chemotherapy, albumin-bound paclitaxel-based chemotherapy, immunotherapy

SBRT arm; SOC arm

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years. Gender is not limited.
• Histologically and/or cytologically confirmed stage IV metastatic NSCLC.
• Eastern Cooperative Oncology Group (ECOG) score of 0-2.
• Patients who had prior first-line chemotherapy with clinical benefit lasting for ≥3 months.
• Driver gene-negative NSCLC patients with oligo-progression during first-line chemotherapy combined with Immune Checkpoint Inhibitors (ICI). Driver gene-positive NSCLC patients, such as epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion positivity, are allowed to enroll if oligo-progression occurred during treatment with first-line chemotherapy combined with bevacizumab ± ICI after failure of Tyrosine Kinase Inhibitor (TKI) therapy.
• Progressive sites were assessed as ≤5 according to RECIST v1.1 criteria combined with positron emission tomography / computertomography (PET/CT), and all were located extracranially. Progressive lymph node lesions are counted by region, with each lymph node region amenable to concurrent SBRT (which may contain multiple progressive lymph nodes) counted as 1 progressive site.
• All progressive sites should be visible on radiologic imaging and assessed as suitable for SBRT treatment by a radiotherapist.
• Intracranial progressive lesions and symptomatic lesions can be treated with palliative radiotherapy and local therapy prior to enrollment and are not counted within the oligo-progressive sites.
• Expected survival time greater than 3 months.
• Comprehensive examination completed within 28 days prior to enrollment in the study and a complete blood count/differential, collected within 15 days, showing that the patient has normal internal organ function and normal bone marrow function.
• Negative serum or urine pregnancy test in females of childbearing age within 14 days prior to study enrollment.
• Patients are willing to provide written informed consent and must be willing to adhere to the prescribed follow-up schedule.

You may not qualify if:

• Currently participating in an interventional clinical study treatment that may affect this study, or have been treated with another investigational drug or investigational device that may affect this study within 4 weeks prior to first treatment.
• Pregnant or lactating women.
• Progression sites deemed unsuitable for SBRT treatment as assessed by radiotherapy specialists.
• Presence of untreated intracranial metastases or symptomatic progressive sites.
• History of malignancy other than NSCLC or untreated primary malignancy within the past 3 years.
• Serious active comorbidities that would interfere with treatment in this study.
• History or evidence of disease that could interfere with the results of the trial, prevent the subject from participating in the study throughout, abnormal values of treatment or laboratory tests, or other conditions that, in the opinion of the investigator, make enrollment inappropriate.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery; Immunotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Immunomodulation; Biological Therapy

Study Officials

• Fuming Qiu, PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fuming Qiu, PhD

CONTACT

86+13858005908; qiufuming@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 26, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)