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)

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Cyanocobalamin (Vitamin B12).

It had two arms (groups): Arm A (standard of care) (active comparator) and Arm B (pembrolizumab, nogapendekin alfa) (experimental).

Patients receive standard of care consisting of docetaxel 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.

Patients receive pembrolizumab IV over 30 minutes and nogapendekin alfa 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.

The registry classes the interventions as biological, dietary supplement and drug.

More on the Plan

To compare overall survival (OS) between participants randomized to nogapendekin alfa (N-803 \[ALT-803\]) + pembrolizumab versus standard of care therapy.

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.

Who Took Part

The registry lists 82 actual participants took part.

It was open to people of any sex.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participants must have been assigned to S1800D by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1800D is determined by the LUNGMAP or S1400 protocol. Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study randomization. For participants who received consolidation anti-PD-1 or anti-PD-L1 therapy following concurrent chemoradiation for Stage III disease as their only line of anti-PD-1 or anti-PD-L1 therapy:. Participants must have recovered (=\< grade 1) from any side effects of prior therapy, except for alopecia. Note: Pemetrexed is not FDA-approved for squamous cell NSCLC and must not be used to treat participants with squamous cell NSCLC.

The full record lists 27 inclusion and 28 exclusion criteria; among the exclusions: participants must not have experienced the following:; any grade 3 or worse immune-related adverse event (irae). exception: asymptomatic nonbullous/nonexfoliative rash; any unresolved grade 2 irae.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Cyanocobalamin (Vitamin B12) study did not mask who received what.

It started in 2022-03-15 with completion listed for 2027-06-30.

It ran at 350 sites in United States (350).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Overall survival (time frame: Up to 2 years).

It also tracked 2 secondary outcomes, for example Investigator-assessed progression-free survival (IA-PFS) and Duration of response (DoR).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Cyanocobalamin (Vitamin B12) in 82 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.