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Active Not RecruitingNCT05096663

Testing the Use of Combination Immunotherapy Treatment (N-803 [ALT-803] Plus Pembrolizumab) Against the Usual Treatment for Advanced Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)

A Phase II/III Study of N-803 (ALT-803) Plus Pembrolizumab Versus Standard of Care in Participants With Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated With Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study)

Status
Active Not Recruiting
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
82 (actual)
Sponsor
SWOG Cancer Research Network · Network
Sex
All
Age
—
Healthy volunteers
Not accepted

Summary

This phase II/III Lung-MAP trial studies how well immunotherapy treatment with N-803 (ALT-803) and pembrolizumab working in treating patients with non-small cell lung cancer that has spread to other places in the body (advanced). Natural killer cells, part of our immune system, are always on alert and ready to defend our bodies from many kinds of infection or rogue cells, such as those that cause cancer. N-803 (ALT-803) may activate natural killer cells so that they can stimulate an immune response to help fight cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving N-803 (ALT-803) and pembrolizumab may help shrink and stabilize lung cancer or prevent it from returning.

Detailed description

PRIMARY OBJECTIVES: I. To compare overall survival (OS) between participants randomized to nogapendekin alfa (N-803 \[ALT-803\]) + pembrolizumab versus standard of care therapy. (Primary Resistance Cohort) II. To compare overall survival (OS) between participants randomized to N-803 (ALT-803) + pembrolizumab versus standard of care therapy. (Acquired Resistance Cohort) SECONDARY OBJECTIVES: I. To compare investigator assessed progression-free survival (IA-PFS) with confirmation of progression by immune response criteria between the treatment arms. II. To compare investigator assessed progression-free survival (IA-PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between the treatment arms. III. To compare the response rates between the arms. IV. To evaluate duration of response (DoR) among responders. V. To evaluate the frequency and severity of toxicities within each treatment arm. TRANSLATIONAL MEDICINE OBJECTIVE: I. To establish a blood repository to pursue future studies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive standard of care consisting of docetaxel intravenously (IV) over 30-60 minutes on day 1; gemcitabine IV over 30 minutes on days 1 and 8; pemetrexed IV over 10 minutes on day 1; or ramucirumab IV over 30-60 minutes and docetaxel IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive pembrolizumab IV over 30 minutes and nogapendekin alfa subcutaneously (SC) on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients then receive nogapendekin alfa SC on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTCobalaminGiven intramuscularly
DRUGDexamethasoneGiven orally (PO)
DRUGDocetaxelGiven IV
DIETARY_SUPPLEMENTFolic AcidGiven PO
DRUGGemcitabineGiven IV
DRUGNogapendekin AlfaGiven SC
BIOLOGICALPembrolizumabGiven IV
DRUGPemetrexedGiven IV
BIOLOGICALRamucirumabGiven IV

Timeline

Start date
2022-03-15
Primary completion
2027-02-01
Completion
2027-12-01
First posted
2021-10-27
Last updated
2025-05-15

Locations

350 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05096663. Inclusion in this directory is not an endorsement.