A Randomised Phase III Trial of Adjuvant Cemiplimab in Patients With Resected Stage II-IIIA NSCLC Who Have Not Received Prior Adjuvant Chemotherapy
ARCH is a randomised, stratified, multicentre, phase III trial. Protocol treatment consists of cemiplimab, 350 mg i.v., every 3 weeks, for 4 cycles, followed by 700 mg i.v., every 6 weeks for 6 cycles or until relapse or unacceptable toxicities, whichever occurs first. The primary objective of the study is to determine the efficacy of adjuvant cemiplimab, as measured by disease-free survival, in patients without prior adjuvant platinum-based chemotherapy, compared to observation without adjuvant treatment. The primary objective will be assessed in patients with tumours with centrally confirmed PD-L1 expression of ≥1%.
• Pathological stage II-IIIA (UICC/ AJCC staging 9th edition) NSCLC Brain imaging should have been performed to complete staging, either preoperatively or postoperatively. If brain imaging has not been performed, a contrast-enhanced CT or MRI of the brain must be performed at screening prior randomisation.
• Complete resection with negative surgical margins (R0).
‣ Acceptable types of surgical resection include any of the following:
• Lobectomy, sleeve lobectomy, bilobectomy, or pneumectomy.
• Segmentectomy for tumours ≤2 cm is permitted in patients with poor pulmonary reserve or another major comorbidity that contraindicates lobectomy.
‣ Wedge resection is not allowed.
⁃ Lymph node dissection should be done according to applicable guidelines.
⁃ No disease recurrence following surgical resection.
• Tumour PD-L1 expression of ≥1%, determined locally using a locally approved immuno-histochemistry test.
• Availability of archival FFPE tumour tissue for central PD-L1 expression testing.
• Patient is not considered for adjuvant platinum-based chemotherapy due to:
‣ Documented patient refusal; or
⁃ Patient is unfit to receive adjuvant platinum-based chemotherapy (per investigator assessment) due to:
∙ ECOG PS2, or ECOG PS 0/1 and aged ≥70 years with substantial comorbidities or other contraindication(s) to platinum-based doublet chemotherapy.
• Estimated life expectancy of ≥3 months.
• Age ≥18 years.
• Patient has recovered from surgery-related complications.
• Adequate haematological, renal and liver function.
• Patient is able to comply with the trial protocol, in the investigator's judgment.
• Negative pregnancy test Female participants of childbearing potential (including women who had their last menstruation in the last 2 years), must have a negative serum pregnancy test within 5 weeks before randomisation. Pregnancy test must be repeated within 3 days before the first dose of protocol treatment and at every treatment visit (urine beta HCG test is sufficient).
• Use of highly effective contraceptive methods Female participants of childbearing potential (including women who had their last menstruation in the last 2 years) and male participants with a female partners of childbearing potential must agree to use a highly effective method of contraception for the duration of the protocol treatment and until 4 months after the last dose of cemiplimab.
• Written Informed Consent must be signed and dated by the patient and the investigator prior to any trial-related intervention.