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ctDNA-Guided Therapy for Lung Cancer (ctDNA Lung RCT Trial)

Phase 2
Recruiting
Led By Natasha Leighl
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate organ and marrow function as defined in Table 4 (3.1.1)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

ctDNA Lung RCT Trial Summary

This trial looks at whether ctDNA can help predict if adjuvant treatment after surgery will decrease the chance of cancer recurrence in lung cancer patients.

Who is the study for?
This trial is for adults over 18 with a specific type of lung cancer (NSCLC) that's been surgically removed. They must have detectable ctDNA, good organ function, and no prior chemo or radiotherapy for this cancer. Participants need to use effective contraception and not be pregnant or breastfeeding. Those with other recent cancers, certain infections like HIV, autoimmune diseases, or who've had recent major surgery can't join.Check my eligibility
What is being tested?
The study tests if checking for ctDNA in the blood after lung cancer surgery can guide adjuvant therapy to prevent cancer recurrence. It involves drugs like Gemcitabine, Cisplatin, Carboplatin, Nivolumab, Pemetrexed alongside the ctDNA blood test.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs used (like Nivolumab), fatigue from chemotherapy agents such as Gemcitabine and Cisplatin; kidney issues from Carboplatin; immune-related effects from Nivolumab; and nausea or anemia from Pemetrexed.

ctDNA Lung RCT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My organs and bone marrow are functioning well.
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My lung cancer type is eligible and lacks targeted treatment options.
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I am using effective birth control and will take a pregnancy test before starting treatment.
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My blood test shows cancer DNA even after surgery.
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I am a man who will use a condom and avoid donating sperm during the study and for 180 days after.
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I haven't had chemotherapy or radiotherapy for my current lung cancer diagnosis.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I weigh at least 35 kilograms.
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My lung cancer was surgically removed and was in the early stages or was a larger, multifocal type.

ctDNA Lung RCT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relapse Free Survival
Secondary outcome measures
Number of adverse events
Overall survival
Rate of ctDNA clearance

ctDNA Lung RCT Trial Design

2Treatment groups
Experimental Treatment
Group I: ObservationExperimental Treatment1 Intervention
All participants will have blood taken for ctDNA testing. Participants will be followed as per standard of care every 3 months.
Group II: Adjuvant chemo-immunotherapy therapyExperimental Treatment6 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670
Nivolumab
2014
Completed Phase 3
~4750
Pemetrexed
2014
Completed Phase 3
~5250

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,463 Previous Clinical Trials
483,465 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,631 Previous Clinical Trials
4,126,602 Total Patients Enrolled
Natasha LeighlPrincipal InvestigatorPrincess Margaret Cancer Centre
3 Previous Clinical Trials
370 Total Patients Enrolled

Media Library

ctDNA blood test Clinical Trial Eligibility Overview. Trial Name: NCT04966663 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Adjuvant chemo-immunotherapy therapy, Observation
Non-Small Cell Lung Cancer Clinical Trial 2023: ctDNA blood test Highlights & Side Effects. Trial Name: NCT04966663 — Phase 2
ctDNA blood test 2023 Treatment Timeline for Medical Study. Trial Name: NCT04966663 — Phase 2
Non-Small Cell Lung Cancer Patient Testimony for trial: Trial Name: NCT04966663 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What purpose does the ctDNA blood test typically fulfill?

"The common urinary bladder ailment is usually treated with a ctDNA blood test, which has also been found to be effective for treating small cell lung cancer (SCLC), advanced testicular cancer, and malignant neoplasms."

Answered by AI

How extensive is the enrollment of individuals for this experiment?

"Affirmative. Clinicaltrials.gov reveals that this experiment is actively seeking participants, which was first posted on March 28th 2022 and updated recently on April 21st 2022. 66 individuals are being sought out by the single trial site."

Answered by AI

Have there been any prior experiences with a ctDNA blood test in clinical trials?

"At present, there are 2048 active trials investigating ctDNA blood tests with 503 at the advanced stage of Phase 3. Most such studies occur in Shanghai; however, they can be found operating in 103733 different sites worldwide."

Answered by AI

Are there still vacancies available in this research project?

"Per the data hosted on clinicaltrials.gov, this trial is open for enrollment at present. The original post date was March 28th 2022 and most recent update occurred April 21st 2022."

Answered by AI

Is there any potential risk associated with a ctDNA blood examination?

"Taking into consideration the lack of efficacy data and presence of safety information, we have assigned ctDNA blood test a score of 2."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Princess Margaret Cancer Centre
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I did not try chemotherapy.
PatientReceived 1 prior treatment
~26 spots leftby Aug 2025