E-Newsletter - October 2020
Spotlight on Alliance Trials
 

Alliance Trial Studies Immunotherapy in Non-small Cell Lung Cancer

Alliance A081801: Integration of immunotherapy into adjuvant therapy for resected NSCLC: ALCHEMIST chemo-IO

Jacob M. Sands, MD, of the Dana-Farber Cancer Institute, is leading Alliance A080801, a phase III ALCHEMIST trial that compares the addition of pembrolizumab to adjuvant chemotherapy versus chemotherapy alone for the treatment of stage IB (>4cm), II, or IIIA (7th ed) non-small cell lung cancer that has been removed by surgery. 

Metastatic non-small cell lung cancer claims far more lives than any other cancer diagnosis [1]. Although surgically resectable non-small cell lung cancer is considered curable, many experience recurrence of the disease. Adjuvant chemotherapy post resection of stage IB-IIIA non-small cell lung cancer is an established standard of care that improves disease-free survival (DFS) and overall survival (OS), but unfortunately, many patients experience a relapse that impacts survival [2]. A regimen that reduces recurrence rates after surgical resection of early-stage non-small cell lung cancer could significantly impact outcomes for a number of patients.

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. The purpose of this trial is to evaluate if the addition of pembrolizumab to usual chemotherapy can improve upon usual chemotherapy alone for non-small cell lung cancer.

This trial’s primary objective is two-fold: 1) to compare the DFS and OS (dual primary endpoints) between combination MK-3475 (pembrolizumab) plus standard of care versus standard of care in patients with stage IB-IIIA non-small cell lung cancer, and 2) to compare the DFS and OS between sequential MK-3475 (pembrolizumab) following standard of care versus standard of care followed by observation in patients with stage IB-IIIA non-small cell lung cancer.

Patients will be randomly assigned to one of three groups. Those in Group 1 will receive platinum doublet chemotherapy (which may include: cisplatin or carboplatin + pemetrexed; cisplatin + gemcitabine; or carboplatin + paclitaxel) intravenously for four cycles. Each cycle lasts 21 days. After this treatment, the oncologist may decide to treat the patient with radiation therapy. Once all treatment has been completed, patients will be observed through clinic visits. Those in Group 2 will receive platinum doublet chemotherapy intravenously for four cycles. Each cycle lasts 21 days. After this treatment, the oncologist may decide to treat the patient with radiation therapy. Once patients have completed this first portion of treatment, patients will be given pembrolizumab intravenously for 17 total cycles (once every 21 days). Those in Group 3 will receive platinum doublet chemotherapy and pembrolizumab intravenously for four cycles. Each cycle lasts 21 days. After this treatment, the oncologist may decide to treat the patient with radiation therapy. Once patients have completed this first portion of treatment, patients will be given additional pembrolizumab alone for 13 more cycles for a total of 17 cycles (once every 21 days). All patients in each group will be followed for up to10 years.     

For complete information on the trial design, treatment plan, and patient eligibility, refer to the study protocol, which can be found on the Alliance website or the CTSU website.  

Study Chair: Jacob M. Sands, MD, Dana-Farber Cancer Institute | E-mail: jacob_sands@dfci.harvard.edu
Activated: 6/03/2020 | Status: Now recruiting participants
CT.gov Link: http://bit.ly/Alliance-A081801

  1. Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2018. CA Cancer J Clin 2018;68:7-30
  2. Pignon JP, Tribodet H, Scagliotti G, et al. Lung Adjuvant Cisplatin Evaluation: A Pooled Analysis by the LACE Collaborative Group. J Clin Oncol 2008;26:3552-59

 

For other articles in this issue of Alliance E-News, see below.