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Tests treatment safety and results for Non-Small Cell Lung Cancer
Official title 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
ClinicalTrials.gov ID: NCT06931717
What this study is testing
What is Cemiplimab?
Cemiplimab is an investigational medicine, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathological stage II-IIIA (UICC/ AJCC staging 9th edition) NSCLC Brain imaging should have been performed to complete staging, either preoperatively...
- 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.
You likely can't join if
- EGFR-mutant or ALK-rearranged NSCLC.
- Any small cell component
- Prior neoadjuvant and/or adjuvant systemic treatment for NSCLC. Note: Previous treatment for another malignancy not excluded as per next criterion...
- Treatment with an approved systemic therapy is completed \>4 weeks before randomisation or
- Treatment with systemic biologic therapy is completed \>5 half-lives before randomisation and patient has recovered from any immune-mediated adverse...
- Participating in another treatment clinical trial for NSCLC.
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- Written Informed Consent must be signed and dated by the patient and the investigator prior to any trial-related intervention.
What rules you out
- EGFR-mutant or ALK-rearranged NSCLC.
- Any small cell component
- Prior neoadjuvant and/or adjuvant systemic treatment for NSCLC. Note: Previous treatment for another malignancy not excluded as per next criterion (Participating in another treatment clinical trial for NSCLC) is allowed...
- Treatment with an approved systemic therapy is completed \>4 weeks before randomisation or
- Treatment with systemic biologic therapy is completed \>5 half-lives before randomisation and patient has recovered from any immune-mediated adverse events and endocrinopathies are adequately managed with hormone...
- Participating in another treatment clinical trial for NSCLC.
- Diagnosis with another malignancy other than NSCLC that is progressing or requires active treatment. Exceptions:
- Non-melanoma skin cancer that has undergone potentially curative therapy
- In situ cervical carcinoma
- Any tumour that has been deemed to be definitively treated, such as definitively treated non-metastatic prostate cancer.
- Has any condition requiring ongoing/continuous corticosteroid therapy (\>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to randomisation. Physiologic replacement doses are allowed even if they...
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments. The following are not exclusions: vitiligo, childhood asthma that has...
- Encephalitis, meningitis, organic brain disease (e.g., Parkinson's disease) or uncontrolled seizures within 1 year prior to randomisation.
- Myocardial infarction within 6 months prior to randomisation.
- Known history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis within 5 years prior to randomisation.
- Uncontrolled infection with HIV, hepatitis B, or hepatitis C infection; or the patient has a diagnosis of immunodeficiency.
- Patients with known HIV infection who have controlled infection [undetectable viral load (HIV RNA PCR) and CD4 count above 350 either spontaneously or on a stable antiviral regimen] are allowed to be included in the...
- Patients with hepatitis B (HBsAg+) with controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection and receiving antiviral therapy for hepatitis B) may be included in the study. Patients...
- Patients who are hepatitis C virus antibody positive (HCV Ab+) with controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) may be included...
- Any infection requiring hospitalisation or treatment with intravenous anti-infectives within 2 weeks before randomisation.
- Receipt of a live vaccine within 28 days before randomisation.
- Receipt of a COVID-19 vaccination within 1 week before randomisation.
- Prior allogeneic stem cell transplantation or received organ transplants at any time, or autologous stem cell transplantation within 12 weeks before randomisation.
- Known or suspected hypersensitivity to cemiplimab or its excipients.
- Women who are pregnant, planning to become pregnant or are in the period of lactation.
- Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.
- Patients who are, or have an immediate family member who is, a member of the clinical study team, unless prior approval has been obtained from the sponsor (ETOP IBCSG Partners Foundation).
- Judgement by the investigator that the patient is unlikely to comply with study procedures, restrictions and requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
- Talinn, Estonia
- Angers, France
- Avignon, France
- Buch, Germany
- Essen, Germany
- München, Germany
- Oldenburg, Germany
- Cork, Ireland
- Dublin, Ireland
- Meldola, Italy
- Milan, Italy
- Novara, Italy
- Pavia, Italy
- Perugia, Italy
- Prato, Italy
- Siena, Italy
- Treviso, Italy
- Verona, Italy
- Singapore, Singapore
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria; Talinn, Estonia; Angers, France; Avignon, France; Buch, Germany; Essen, Germany and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.