Low-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer

Conditions

• Lung Non-Small Cell Carcinoma
• Stage IV Lung Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage IVB Lung Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Aldesleukin — BIOLOGICAL
  Given SC
• Pembrolizumab — BIOLOGICAL
  Given IV

Study Details

This early phase 1 trial will investigate the combination of low-dose interleukin-2 (IL-2) and pembrolizumab in patients with previously untreated stage IV non-small cell lung cancer (NSCLC). Preclinical data demonstrate reinvigoration of exhausted T cells into an effector-like phenotype with improved anti-tumor activity in response to this combination. This study will evaluate T cell function as well as clinical outcomes associated with this combination therapy.

Key Dates

Start date

Nov 1, 2022

Status verified

Feb 2026

Primary completion

Jan 7, 2027

Completion

Jan 7, 2028

Study Design

Enrollment

15 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (pembrolizumab, aldesleukin)
  Patients will be treated with pembrolizumab 200 mg IV once every 3 weeks in combination with IL-2 given at 5 million IU subcutaneously twice daily for 3 weeks (5 days on, 2 days off each week, first dose in clinic and subsequent doses at home). IL-2 will be given only for the three weeks, after which pembrolizumab will be continued as monotherapy at either 200 mg every 3 weeks or 400 mg every 6 weeks.

Primary Outcome Measure

Immune Response To Combination IL-2 and Pembrolizumab [ Time Frame: Change from Baseline at weeks 1, 2, 3, 6, 12, and 18 ]

Central Contacts

• Suresh S. Ramalingam, MD, FACP, FASCO
  404-778-5378
  [email protected]
• Ralph Millett, MD
  [email protected]

Locations (1)

Find similar trials in Atlanta, GA

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