Stereotactic Body Radiation Therapy Followed by Surgery in Treating Patients With Stage I-IIIA Non-small Cell Lung Cancer

NCT03348748 | Terminated Early Phase 1 DMC FDA Drug

• 2 other identifiers: I 50717NCI-2017-01950
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies the effects of stereotactic body radiation therapy followed by surgery in treating patients with stage I-IIIA non-small cell lung cancer. Stereotactic body radiation therapy is a method of radiation that uses imaging to precisely locate a tumor and then deliver very high radiation doses to the tumor site in order to limit normal tissue toxicity or damage.

Conditions

Stage I Non-Small Cell Lung Cancer AJCC v7; Stage IA Non-Small Cell Lung Carcinoma AJCC v7; Stage IB Non-Small Cell Lung Carcinoma AJCC v7; Stage II Non-Small Cell Lung Cancer AJCC v7; Stage IIA Non-Small Cell Lung Carcinoma AJCC v7; Stage IIB Non-Small Cell Lung Carcinoma AJCC v7; Stage IIIA Non-Small Cell Lung Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-related grade 3-5 adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0

  Comparison will be made with published historical and contemporaneous rates of toxicity with standard of care therapy for each of the study groups.

  Up to 10 weeks post-surgery

Secondary Outcomes (2)

• Overall survival

  Up to 5 years

• Progression free survival

  Up to 5 years

Other Outcomes (3)

• Change in the mediators of tumor antigen presentation, co-stimulatory molecules, and immune effector cell populations assessed using multicolor flow cytometry, immunohistochemistry, and enzyme-linked immunosorbent assay (ELISA)

  Baseline up to 10 weeks post-surgery

• Factors associated with T cell immunity in pathologic specimens

  After surgery

• Incidence of adverse events assessed using the NCI CTCAE v4.0

  Up to 10 weeks post-surgery

Study Arms (3)

Study 1 (highest-dose of SBRT, surgery)

EXPERIMENTAL

Patients with stage I or II NSCLC in the peripheral lung undergo highest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.

Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Drug: Stereotactic Body Radiation Therapy; Procedure: Thoracic Surgical Procedure

Study 2 (lowest-dose of SBRT, surgery)

EXPERIMENTAL

Patients with stage I or II NSCLC in the central lung undergo lowest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.

Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Drug: Stereotactic Body Radiation Therapy; Procedure: Thoracic Surgical Procedure

Study 3 (lowest- or higher-dose of SBRT, surgery)

EXPERIMENTAL

Patients with stage IIIA NSCLC in the any lung location undergo lowest- or higher-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.

Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Drug: Stereotactic Body Radiation Therapy; Procedure: Thoracic Surgical Procedure

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Study 1 (highest-dose of SBRT, surgery); Study 2 (lowest-dose of SBRT, surgery); Study 3 (lowest- or higher-dose of SBRT, surgery)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Study 1 (highest-dose of SBRT, surgery); Study 2 (lowest-dose of SBRT, surgery); Study 3 (lowest- or higher-dose of SBRT, surgery)

Stereotactic Body Radiation Therapy DRUG

Undergo lowest-dose of SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Study 2 (lowest-dose of SBRT, surgery)

Thoracic Surgical Procedure PROCEDURE

Undergo thoracic surgery

Also known as: Chest Surgery, Thoracic Surgery, Thoracic Surgical Procedures

Study 1 (highest-dose of SBRT, surgery); Study 2 (lowest-dose of SBRT, surgery); Study 3 (lowest- or higher-dose of SBRT, surgery)

Eligibility Criteria

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

You may qualify if:

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
• Have histologically proven diagnosis of: non-small cell lung cancer (NSCLC) (stage I, II, or IIIa)
• Neoadjuvant or induction chemotherapy or biological (immune, vaccine, etc.)therapy for stage IIIa is allowed
• Chemotherapy for another invasive malignancy is permitted if it has been treated definitively and the patient has remained disease free for \>3 years
• Participant is able to undergo surgery (planned lobectomy or wedge resection)
• Specifically, the participant has been or will have been cleared for surgery at the time of enrollment; the surgeon can accept the baseline tests done within 45 days prior to SBRT to clear the patient for surgery
• Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) during treatment
• Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

You may not qualify if:

• Contraindication to SBRT (this includes the inability to cooperate with any aspect of SBRT: such as the inability to lie still and breathe reproducibly)
• Previous radiotherapy to the volume of lung or mediastinum currently involved by tumor
• Previous surgery for this lung or mediastinum tumor
• Patients with active systemic, pulmonary, or pericardial infection
• Pregnant or nursing female participants
• Unwilling or unable to follow protocol requirements
• Any condition which in the investigator?s opinion deems the participant ineligible
• Received an investigational agent within 30 days prior to enrollment
• Stage IIIb

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery; Thoracic Surgical Procedures

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

Study Officials

• Anurag Singh

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 21, 2017
• Study Start: December 18, 2017
• Primary Completion: July 12, 2021
• Study Completion: November 10, 2025
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

US (1)