A Study of the Efficacy and Safety of RO7198457 in Combination With Atezolizumab Versus Atezolizumab Alone Following Adjuvant Platinum-Doublet Chemotherapy in Participants Who Are ctDNA Positive After Surgical Resection of Stage II-III Non-Small Cell Lung Cancer

STATUS

Recruiting
End date

Sep 30, 2025
participants needed

80
sponsor

Hoffmann-La Roche

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Updated on 19 February 2024

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cancer

ct scan

atezolizumab

lung cancer

immunomodulators

cancer chemotherapy

hepatitis

hiv test

non-small cell lung cancer

small cell lung cancer

Summary

Show definitions

This study will evaluate the efficacy, safety, pharmacokinetics, immunogenicity and biomarkers of RO7198457 plus atezolizumab compared with atezolizumab alone in patients with Stage II-III non-small cell lung cancer (NSCLC) who are circulating tumor DNA (ctDNA) positive following surgical resection and have received standard-of-care adjuvant platinum-doublet chemotherapy.

Details

Condition	Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer
Age	18years - 100years
Treatment	Atezolizumab, RO7198457
Clinical Study Identifier	NCT04267237
Sponsor	Hoffmann-La Roche
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age >= 18 years
	Resected Stage II-III Non-small Cell Lung Cancer (NSCLC) per American Joint Committee on Cancer staging criteria, 8th revised edition
	Complete R0 resection of Stage II or III NSCLC prior to enrollment and adequate recovery from surgery
	Pathological evaluation of mediastinal lymph nodes preoperatively or intraoperatively
	ctDNA (circulating tumor DNA) identified in plasma after resection of Stage II-III NSCLC and prior to start of adjuvant platinum-doublet therapy, as determined by central testing
	Treatment with at least two cycles of adjuvant platinum-doublet chemotherapy regimens for resected NSCLC
	No unequivocal evidence of disease after surgery and adjuvant platinum-doublet chemotherapy, as assessed on imaging (computed tomography [CT] scan or magnetic resonance imaging [MRI]) within 28 days prior to randomization
	Availability of adequate tumor material
	Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
	Adequate hematologic and end-organ function
	Negative HIV test at screening
	Negative hepatitis B test at screening
	Negative hepatitis C test at screening
Exclusion Criteria
	Participants with a known mutation in exons 18-21 of epidermal growth factor receptor (EGFR) or with a known anaplastic lymphoma kinase (ALK) or reactive oxygen species (ROS) alteration
	History of malignancy other than disease under study within 5 years prior to enrollment, with the exception of malignancies with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
	Induction and neoadjuvant systemic therapy prior to resection of NSCLC
	Radiotherapy prior to or after resection of NSCLC
	Prior systemic investigational therapy
	Prior anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, or a cancer vaccine
	Treatment with systemic immunostimulatory agents within 6 weeks or 5 drug elimination half-lives, prior to initiation of study treatment
	Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during study treatment
	Treatment with monoamine oxidase inhibitors (MAOIs) within 3 weeks prior to initiation of study treatment or requirement for ongoing treatment with MAOIs
	Active or history of autoimmune disease or immune deficiency
	Known primary immunodeficiencies, either cellular or combined T-cell and B-cell immunodeficiencies
	History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
	Significant cardiovascular disease
	Major surgical procedure, other than for diagnosis or for resection of disease under current study, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
	Known active or latent tuberculosis infection
	Recent acute infection
	Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment or within 5 months after the final dose of study treatment
	Prior allogeneic stem cell or solid organ transplantation
	Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participants at high risk from treatment complications
	Known clinically significant liver disease
	Previous splenectomy
	History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
	Known hypersensitivity to Chinese hamster ovary cell products or any component of the atezolizumab formulation
	Known allergy or hypersensitivity to any component of RO7198457
	Pregnant or lactating women

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A Study of the Efficacy and Safety of RO7198457 in Combination With Atezolizumab Versus Atezolizumab Alone Following Adjuvant Platinum-Doublet Chemotherapy in Participants Who Are ctDNA Positive After Surgical Resection of Stage II-III Non-Small Cell Lung Cancer