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ETOP ARCH

A clinical trial to investigate the efficacy of adjuvant immunotherapy with cemiplimab in patients with surgically removed non-small cell lung cancer who have not previously received chemotherapy.

Coordinating Investigator

  • Laetitia Mauti

    Laetitia Mauti

    Vice President Project Group Lung Cancer

Summary of the study

The ARCH trial is a clinical trial for people with early-stage non-small cell lung cancer that has been surgically removed but has not undergone chemotherapy after surgery. Chemotherapy is often given to prevent recurrence of the lung cancer. Following chemotherapy or in combination with it, immunotherapy is sometimes administered to help the immune system fight any remaining cancer cells. However, immunotherapy can currently only be administered together with or after chemotherapy. However, chemotherapy is not an option for everyone. Some are not healthy enough or decide against chemotherapy because of the side effects. It is currently unclear whether immunotherapy can help to reduce the likelihood of lung cancer recurring after surgery if chemotherapy could not or cannot be administered. In this clinical trial, we therefore want to find out whether immunotherapy with cemiplimab (Libtayo®) helps to reduce the recurrence of cancer after surgery, even without additional chemotherapy. The study will involve 390 patients from around 9 countries. In Switzerland, it is planned that 50 patients will take part.

Intervention studied

Patients taking part in the ARCH study had their lung cancer surgically removed before the start of the study and did not undergo subsequent chemotherapy. The lung cancer contains the PD-L1 molecule.

Patients are randomly assigned to one of two groups:
Group 1: Patients receive 10 cycles of immunotherapy with cemiplimab for approximately one year (the first four doses are given 3-weekly, the remaining doses 6-weekly).
Group 2: Patients in this group receive no additional drug treatment.

Overall, participation in the ARCH study lasts 3-4 years.

Cemiplimab is administered as an infusion directly into the vein. The treatment is carried out as long as the lung cancer remains stable and the side effects are tolerable.

The study participants must visit the study doctor in hospital at the following times:

  • before the start of the study
  • during treatment with cemiplimab 4 times at 3-week intervals, followed by 6 times at 6-week intervals.
  • Year 2 & 3 every 3 months

Disease(s) investigated

Lung cancer, known as non-small cell lung cancer (NSCLC), which is still at an early stage and has been surgically removed.

Inclusion and exclusion criteria

Criteria for participation

  • Completely surgically removed non-small cell lung cancer in early stage II-IIIA.
  • At least 1% of the cells in the tumor have the PD-L1 protein on their surface.
  • Chemotherapy is not an option after surgical removal of the cancer.

Exclusion criteria

  • Change in the EGFR gene or rearrangement of the genetic material (ALK rearrangement).
  • Systemic treatment before or after surgery for lung cancer.
  • Persistent or recent signs of a severe autoimmune disease requiring therapy.
  • Pregnant or breastfeeding women.
Further study information

Clinics

  • Kantonsspital Winterthur
    Kantonsspital Winterthur
  • Universitätsspital Basel
    Universitätsspital Basel

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