Treatment study of immunotherapy and chemotherapy for non-small cell lung cancer

Study ID: ALCHEMIST Chemo-IO

Testing the addition of immunotherapy to chemotherapy for non-small cell lung cancer: ALCHEMIST Chemo-IO Study

Researchers conducting this randomized phase III trial seek to determine if the FDA-approved immunotherapy Keytruda® (pembrolizumab) and the usual chemotherapy can help patients diagnosed with non-small cell lung cancer who have undergone surgical removal of their tumors.

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. Chemotherapy works in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing or spreading to other parts of the body.

The purpose of this trial is to determine if the addition of pembrolizumab to usual chemotherapy is better or worse than usual chemotherapy alone for treating non-small cell lung cancer. Each participant is randomized into one of three groups. All participants receive the initial treatment of platinum-based chemotherapy (based on the treating physician’s choice) every 21 days for 4 cycles.

  • Arm 1: Patients then undergo observation.
  • Arm 2: After initial treatment of chemotherapy ends, patients then receive pembrolizumab intravenously every 21 days for 17 cycles.
  • Arm 3: Patients receive the initial treatment of chemotherapy as well as pembrolizumab every 21 days for 4 cycles. After that, they receive pembrolizumab alone every 21 days for 13 cycles.

This phase III trial compares the addition of pembrolizumab to usual chemotherapy vs. usual chemotherapy for the treatment of stage IB, II, or IIIA non-small cell lung cancer that has been removed by surgery.

Eligible participants are those whose genetic testing shows no EGFR exon 19 deletion or EGFR L858 R mutation and no ALK rearrangement.

Each participant is randomized into one of three study arms:

  • Arm 1 Initial therapy: 1 of 4 platinum doublet regimens based on the treating physician’s choice. Treatment repeats every 21 days for 4 cycles. Continuance therapy: observation
  • Arm 2 Initial therapy: 1 of 4 platinum doublet regimens based on the treating physician’s choice. Treatment repeats every 21 days for 4 cycles. Continuance therapy: Pembrolizumab IV over 25-40 minutes on day 1. Treatment repeats every 21 days for 17 cycles.
  • Arm 3 Initial therapy: 1 of 4 platinum doublet regimens based on the treating physician’s choice and pembrolizumab IV over 25-40 minutes on day 1. Treatment repeats every 21 days for 4 cycles. Continuance therapy: Pembrolizumab IV over 25-40 minutes on day 1. Treatment repeats every 21 days for 13 cycles.

Inclusion Snapshot

  • Must have been previously registered in trial A151216 
  • Must have been diagnosed with stage IB, II or IIIA non-small cell lung cancer
  • Must have undergone surgical removal of their tumors
  • Genetic testing must show no EGFR genetic deletion or mutation or ALK gene anomaly
  • Must not have received prior therapy for current lung cancer diagnosis
  • Other inclusion and exclusion criteria apply

Contact Information

Lankenau Institute for Medical Research trial