Loading clinical trials...

RECRUITINGPHASE2

Using ctDNA to Determine Therapies for Lung Cancer

From Liquid Biopsy to Cure: Using ctDNA Detection of Minimal Residual Disease to Identify Patients for Curative Therapy After Lung Cancer Resection

NCT04966663•University Health Network, Toronto

View on ClinicalTrials.gov

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.

Detailed Description

For people who have early stage non-small cell lung cancer (NSCLC), the usual treatment is surgery. For many people, surgery is enough to get rid of all the cancer. However, for some people, there may be a little bit of cancer remaining. If there is some cancer left over, it may lead to the cancer regrowing. This is called relapse. Many cancers shed little bits of their DNA (deoxyribonucleic acid, molecules that contain instructions for how cells develop and function) into the bloodstream. A blood test can be used to test for the amount of circulating tumour DNA (ctDNA). Some studies have shown that the presence of ctDNA in the blood may predict cancer recurrence. The purpose of this research study is to see if adjuvant treatment (additional treatment given after primary treatment) can help decrease the risk of the cancer recurring in people with lung cancer who have ctDNA detected in their blood after surgery.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years at the time of screening
•2. Written informed consent obtained from the subject prior to performing any protocol-related procedures
•3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•4. Weight ≥ 35 kg
•5. Must have a life expectancy of at least 24 months
•6. Complete surgical resection of T1-2N0M0 NSCLC or T3/T4 multifocal NSCLC
•7. Any pathologic subtype of NSCLC is eligible, including adenocarcinoma and squamous carcinoma. Patients with targetable genomic alterations without approved or available targeted adjuvant therapy options are eligible
•8. Patients with detectable plasma ctDNA before or after complete surgical resection are eligible (RaDaR TM assay, Inivata Morrisville, North Carolina, USA).
•9. No prior chemotherapy or radiotherapy is allowed for the current diagnosis of resected NSCLC.
•10. Adequate organ and marrow function as defined in Table 4 (3.1.1)
+2 more criteria

Exclusion Criteria

•1. Participants that should receive adjuvant chemotherapy per standard of care (resected N1 or N2 disease, primary tumour \>=4 cm).
•2. 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;
•3. Prior receipt of any immune-mediated anti-cancer therapy including, but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1 antibodies including nivolumab and agents targeting CD73, CD39, or adenosine receptors;
•4. Incomplete surgical resection;
•5. Concurrent enrolment in another therapeutic clinical study of systemic anti-cancer treatment. Enrolment in observational or supportive studies will be allowed;
•6. 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;
•7. Active autoimmune disorders within the past 3 years prior to the scheduled first dose of study treatment. The following are exceptions to this criterion:
•1. Subjects with vitiligo or alopecia.
•2. Subjects with hypothyroidism (e.g., following Hashimoto syndrome) not requiring systemic treatment or stable on hormone replacement.
•3. Subjects with psoriasis not requiring systemic treatment.
+20 more criteria

Locations (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Key Dates

Start Date

March 28, 2022

Primary Completion Date

August 1, 2026

Completion Date

December 1, 2026

Last Updated

December 18, 2025

Enrollment

ESTIMATED participants

Conditions

Non Small Cell Lung CancerComplete Surgical ResectionCirculating Tumor DNA

Interventions

Nivolumab

DRUG

Pemetrexed

DRUG

Gemcitabine

DRUG

Cisplatin

DRUG

Carboplatin

DRUG

ctDNA blood test

PROCEDURE

Contacts

Natasha Leighl, M.D.

CONTACT

416-946-4645 Natasha.Leighl@uhn.ca

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

NCT06066138

Locally Advanced Alveolar Soft Part SarcomaMetastatic Alveolar Soft Part Sarcoma+8 more

View study

RECRUITING

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

NCT07485114

Renal Cell Carcinoma (Kidney Cancer)Non Small Cell Lung Cancer+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Using ctDNA to Determine Therapies for Lung Cancer

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)