Using ctDNA to Determine Therapies for Lung Cancer

• Status: Not yet recruiting
• Trial end date: 2025-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to look at whether the presence of circulating tumour DNA (ctDNA) in the blood can help to predict whether giving adjuvant treatment after surgery can decrease the chance of the cancer coming back in people with lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Bristol-Myers Squibb
• Treatments: Carboplatin; Gemcitabine; Nivolumab; Pemetrexed

Criteria

Inclusion Criteria:

• Age ≥ 18 years at the time of screening

• Written informed consent obtained from the subject prior to performing any protocol-related procedures

• Complete surgical resection of T1-2N0M0 or T3/T4 multifocal non-small cell lung cancer

• Any pathologic subtype of non-small cell lung cancer is eligible, including adenocarcinoma and squamous carcinoma. Patients with targetable genomic alterations without approved or available targeted adjuvant therapy options are eligible

• Patients with evidence of minimal residual disease based on detectable plasma ctDNA at 3-6 weeks post complete surgical resection are eligible.

• No prior chemotherapy or radiotherapy is allowed for the current diagnosis of resected non-small cell lung cancer

• Adequate organ and marrow function

Exclusion Criteria:

• Participants that should receive adjuvant chemotherapy per standard of care

• Receipt of any conventional or investigational anticancer therapy within 21 days or radiotherapy within 14 days prior to the scheduled first dose of study treatment

• Prior receipt of any immune-mediated anti-cancer therapies

• Incomplete surgical resection

• Concurrent enrolment in another therapeutic clinical study of systemic anti-cancer treatment. Enrolment in observational or supportive studies will be allowed

• Subjects with a recent history of myocardial infarction, congestive heart failure ≥ Class 3 based on New York Heart Association Functional Classification or stroke within the past 3 months prior to the scheduled first dose of study treatment

• Active autoimmune disorders within the past 3 years prior to the scheduled first dose of study treatment

• Have known uncontrolled human immunodeficiency virus (HIV)-1/2 infection

• History of primary immunodeficiency, solid organ transplantation, or active tuberculosis