PembRolIzuMab and Stereotactic Body Radiotherapy In Metastatic Non-small-cell lunG Cancer Patients

Sponsor
Royal Marsden NHS Foundation Trust
Study ID
NCT03436056
Phase
PHASE1
Status
Terminated

Conditions

  • Metastatic Non-small-cell lunG Cancer

Eligibility Criteria

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

Interventions

  • Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#) — RADIATION
    Stereotactic Body Radiotherapy (SBRT) dosed at 30 Gy in 3 fractions (#) in week 3
  • Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#) — RADIATION
    Stereotactic Body Radiotherapy (SBRT) dosed at 54 Gy in 3 fractions (#) in week 3
  • Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose — RADIATION
    Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose (MTD) determined in Part A in week 3
  • Pembrolizumab — DRUG
    Pembrolizumab in week 1 dosed at 200 mg (prior to SBRT) and then treatment with pembrolizumab will be continued dosed at 200 mg given every 3 weeks.

Study Details

This is a single centre non-randomised open label phase 1 trial of lung SBRT to part of a lung lesion in patients with advanced NSCLC in combination with pembrolizumab. This study will recruit up to 24 patients whose lung cancer has progressed beyond one line of palliative chemotherapy, and an EGFR or ALK inhibitor if an EGFR driver mutation or ALK gene rearrangement is present, respectively, and now requires further palliative systemic treatment.

Key Dates

Start date
Mar 1, 2018
Status verified
Jan 2026
Primary completion
Jul 8, 2019
Completion
Jul 8, 2019

Study Design

Enrollment
2 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: Dose escalation cohort - DOSE LEVEL 1
    Intervention: One dose pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
  • Other: Dose escalation cohort - DOSE LEVEL 2
    Intervention: One dose of pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
  • Other: Part B - Expansion cohort
    Intervention: One dose of pembrolizumab 200 mg (week 1) followed in by lung Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose determined in Part A in week 3, dosed at the maximum tolerated dose determined in Part A. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.

Primary Outcome Measure

Proportion of Patients With Dose Limiting Toxicity [ Time Frame: From first dose of Pembrolizumab to 12 weeks from the last dose of lung SBRT ]

Related coverage on Hipa.ai

Related Studies