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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

ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorETOP IBCSG Partners Foundation

About this trial

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%.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

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.

Disqualifiers

EGFR-mutant or ALK-rearranged NSCLC.

Any small cell component

Prior neoadjuvant and/or adjuvant systemic treatment for NSCLC.

Treatment with an approved systemic therapy is completed >4 weeks before randomisation or

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cemiplimab

    Drug

    Cemiplimab, 350 mg i.v., every 3 weeks (±3 days), for 4 cycles, followed by 700 mg i.v., every 6 weeks (±1 week) for 6 cycles or until relapse or unacceptable toxicities, whichever occurs first.

Treatment groups

390 Participants
are divided into 2 treatment groups
Group A: Experimental Arm: CemiplimabExperimental treatment 1 intervention
Group B: Control Arm: ObservationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Disease-free survival (DFS)

Disease free survival (in patients with tumours with centrally confirmed PD-L1 expression of ≥1%).

Time frame
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.

Secondary outcomes

1

Overall survival (OS)

OS is defined as the time from the date of randomisation until death from any cause. Censoring (for patients who are not reported as having died) will occur at the date last known to be alive. Patients without post-randomisation information will be censored at the date of randomisation (plus 1 day).

Time frame
From the date of randomisation until death from any cause. Assessed for approximately up to 59 months.
2

Incidence, nature and severity of adverse events according to CTCAE v5.

All safety parameters will be summarised in tables to evaluate the toxicity/safety profile of the protocol treatment.

Time frame
From the date the patient has signed the Informed Consent until the trial end. Assessed for approximately up to 59 months.

Other outcomes

Sponsors and contacts

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ETOP IBCSG Partners Foundation

Lead sponsor

Regeneron Pharmaceuticals

Collaborator

Source ClinicalTrials.gov
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