The Selective Personalized Radio-Immunotherapy for Locally Advanced Non-Small Cell Lung Cancer Trial 2

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT07146230
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Durvalumab is a human mAb of the immunoglobulin G 1 kappa subclass that blocks the interaction of PD-L1 (but not PD-L2) with PD 1 on T cells and CD80 (B7.1) on immune cells.
  • Monalizumab — DRUG
    Monalizumab is a humanized mAb of the IgG4 subtype that specifically binds and inhibits Cluster of Differentiation 94 (CD94)/NK cell protein group 2 A(NKG2A).
  • Oleclumab — DRUG
    Oleclumab is a human IgG1λ mAb that selectively binds to and inhibits the ectonucleotidase activity of CD73.
  • Radiotherapy — RADIATION
    PET based dose painted radiotherapy. If these treatment techniques are not available for some reason treatment may be delivered using a sequential boost technique (2.75 Gy x 17 to the low-risk PTV followed by 2.75 Gy x 3 to the high-risk planning target volume).

Study Details

This is a randomized trial evaluating the efficacy and safety of sequential dual-agent immunotherapy and risk-adapted radiotherapy for patients with locally advanced non-small cell lung cancer (NSCLC) with a PD-L1 tumor proportion score of at least 50%. Participants will be randomized between two dual-agent immunotherapy regimens: durvalumab + monalizumab versus durvalumab + oleclumab.

Key Dates

Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab + Monalizumab Arm
    Durvalumab 1500 mg IV and monalizumab 1500 mg IV on day 1 of a 28-day cycle for two cycles, followed by four weeks of risk adapted, dose-painted, radiotherapy, followed by durvalumab 1500 mg IV and monalizumab 1500 mg IV on day 1 of 28-day cycle for up to ten cycles.
  • Experimental: Durvalumab + Oleclumab Arm
    Durvalumab 1500 mg IV on day 1 and oleclumab 3000 mg IV on day 1 and 15 of a 28-day cycle for two cycles, followed by four weeks risk adapted, dose-painted radiotherapy, followed by durvalumab 1500 mg and oleclumab 3000 mg on day 1 of 28-day cycles for up to ten cycles.

Primary Outcome Measure

Response rate observed using FDG-PET imaging [ Time Frame: Following completion of two cycles of induction dual-agent immunotherapy; approximately 9 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10461
Nitin R Ohri, MD
[email protected]
718-405-8550

Find similar trials in The Bronx, NY

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Montefiore Medical Center· The Bronx, NY

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