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Using ctDNA to Determine Therapies for Lung Cancer (ctDNA Lung RCT)

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ClinicalTrials.gov Identifier: NCT04966663
Recruitment Status : Recruiting
First Posted : July 19, 2021
Last Update Posted : April 28, 2022
Bristol-Myers Squibb
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Complete Surgical Resection Circulating Tumor DNA Drug: Nivolumab Drug: Pemetrexed Drug: Gemcitabine Drug: Cisplatin Drug: Carboplatin Procedure: ctDNA blood test Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: From Liquid Biopsy to Cure: Using ctDNA Detection of Minimal Residual Disease to Identify Patients for Curative Therapy After Lung Cancer Resection
Actual Study Start Date : March 28, 2022
Estimated Primary Completion Date : August 1, 2025
Estimated Study Completion Date : December 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Adjuvant chemo-immunotherapy therapy

All participants will have blood taken for ctDNA testing.

A cycle is 21 days. Pemetrexed (for participants with non-squamous non-small cell lung cancer), intravenously (by vein) on Day 1 of Cycles 1-4, OR gemcitabine (for all other participants) on Days 1 and 8 of Cycles 1-4.

Cisplatin*, intravenously (by vein) on Day 1 of Cycles 1-4 Nivolumab, intravenously (by vein) on Day 1 of Cycles 1-4

*If cisplatin is not tolerated, carboplatin may be given instead

Drug: Nivolumab
Antineoplastic agent

Drug: Pemetrexed
Antineoplastic agent

Drug: Gemcitabine
Antineoplastic agent

Drug: Cisplatin
Antineoplastic agent

Drug: Carboplatin
Antineoplastic agent

Procedure: ctDNA blood test
Blood will be collected for ctDNA testing


All participants will have blood taken for ctDNA testing.

Participants will be followed as per standard of care every 3 months.

Procedure: ctDNA blood test
Blood will be collected for ctDNA testing

Primary Outcome Measures :
  1. Relapse Free Survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Rate of ctDNA clearance [ Time Frame: 12 weeks ]
  2. Overall survival [ Time Frame: 3 years ]
  3. Number of adverse events [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04966663

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Contact: Natasha Leighl, M.D. 416-946-4645 Natasha.Leighl@uhn.ca

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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Natasha Leighl, M.D.         
Sponsors and Collaborators
University Health Network, Toronto
Bristol-Myers Squibb
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Principal Investigator: Natasha Leighl Princess Margaret Cancer Centre
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04966663    
Other Study ID Numbers: CtDNA Lung RCT
First Posted: July 19, 2021    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors