A Clinical Study to Assess the Efficacy of Adjuvant Immunotherapy With Cemiplimab in Patients Wit… (NCT06931717) | Clinical Trial Compass
RecruitingPhase 3
A Clinical Study to Assess the Efficacy of Adjuvant Immunotherapy With Cemiplimab in Patients With Surgically Removed Non-small Cell Lung Cancer Who Have Not Received Prior 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%.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 c…
What they're measuring
1
Disease-free survival (DFS)
Timeframe: From the date of randomisation until disease recurrence (including loco-regional recurrence, a distant (metastatic) recurrence or a second primary) or death from any cause. Assessed for approximately up to 59 months.