Acasunlimab + Pembrolizumab for Lung Cancer

Recruiting in Palo Alto (17 mi)

+51 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Genmab

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called acasunlimab, alone and with pembrolizumab, in patients with non-small cell lung cancer who did not improve with standard treatments. The drugs aim to help the immune system fight cancer more effectively.

Eligibility Criteria

Adults with stage 4 non-small cell lung cancer who've had prior treatment including anti-PD-1/PD-L1 antibodies can join this trial. They should be relatively active (ECOG ≤1), have a life expectancy of at least 3 months, and tumors expressing PD-L1 in ≥1% of cells. Excluded are those with recent radiation or immunotherapy side effects, severe heart conditions, uncontrolled hypertension, certain genetic mutations unless previously treated for them, significant autoimmune disease risk, liver disease, organ transplants within the last 3 months or known allergies to trial drugs.

Inclusion Criteria

I am 18 years old or older.

I have stage 4 NSCLC and was treated with an anti-PD-1/PD-L1 drug.

My organs and bone marrow are functioning well.

+5 more

Exclusion Criteria

I have not used experimental drugs for stage 4 lung cancer.

I do not have severe heart failure, unstable chest pain, or irregular heartbeats.

I haven't taken high doses of steroids like prednisone before starting the trial.

+10 more

Participant Groups

The trial is testing acasunlimab alone and combined with pembrolizumab in patients whose lung cancer has worsened after standard care. It aims to see how safe these treatments are and how well they work against the cancer.

3Treatment groups

Experimental Treatment

Group I: Arm CExperimental Treatment2 Interventions

Treatment with acasunlimab + pembrolizumab once every 42 days

Group II: Arm BExperimental Treatment2 Interventions

Treatment with acasunlimab + pembrolizumab once every 21 days

Group III: Arm AExperimental Treatment1 Intervention

Treatment with acasunlimab once every 21 days for the first 2 cycles and then every 42 days in subsequent cycles