Stereotactic Ablative Radiotherapy With Nivolumab for Early-Stage Operable Non-Small Cell Lung Cancer

Sponsor
Hospital Israelita Albert Einstein
Study ID
NCT04271384
Phase
PHASE2
Status
Completed

Conditions

  • Non-small Cell Lung Cancer Stage I

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nivolumab — COMBINATION_PRODUCT
    Combined neoadjuvant therapy consisting of nivolumab + SABR

Study Details

Stage 1 non-small cell lung cancer (NSCLC) carries up to 30% chance of relapse in 5 years. This a phase 2 study that aims to determine the pathological complete response of the combination of stereotactic ablative radiotherapy (SABR) plus nivolumab as neoadjuvant treatment in early-stage non-small cell lung cancer. The patients will receive standard SABR + nivolumab at a dose of 360 mg every 21 days for 3 doses. The patient will undergo surgery 10 weeks after the last radiotherapy dose.

Key Dates

Start date
Feb 12, 2020
Status verified
Dec 2023
Primary completion
Nov 15, 2023
Completion
Nov 15, 2023

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SABR + Nivolumab
    Pre-operative treatment with standard SABR (3 x 18 Gy or 5 x 10 Gy or 8 x 7.5 Gy) concomitant with nivolumab at 360 mg every 21 days x3 doses. Standard-of-care surgery to be performed after 12 weeks from D1 of treatment.

Primary Outcome Measure

Percentage of Pathologic complete response (pCR) after Pre-operative therapy [ Time Frame: 12 weeks after first day of neoadjuvant therapy ]

Related Studies