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

Send

Updated on 19 February 2024

See if I qualify

cancer

ct scan

atezolizumab

lung cancer

immunomodulators

cancer chemotherapy

hepatitis

hiv test

non-small cell lung cancer

small cell lung cancer

Summary

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

How understandable was the trial content above?

Hard to understand

Easy to understand

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

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

I am at least 18 years old.

By sending a message, I agree to share my information with the study team for the selected site and consent to receive emails and text messages for trial updates, notifications, and related communication. TrialX values your privacy; your information will be handled in accordance with our Privacy Policy

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

non-small cell lung cancer

small cell lung cancer

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

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