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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

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

Patients with detectable plasma ctDNA before or after complete surgical resection are eligible (RaDaR TM assay, Inivata Morrisville, North Carolina, USA).

Must not have

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;

History of more than one event of infusion related reactions (IRR) requiring permanent discontinuation of IV drug treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer type is eligible and lacks targeted treatment options.

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My blood test shows cancer DNA even after surgery.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not received any immune therapy for cancer, such as drugs targeting CTLA-4, PD-1, or PD-L1.

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I've had to stop IV drug treatments more than once due to bad reactions.

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I am not incarcerated and can consent and follow study rules.

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I have not had major surgery in the last 28 days or am still recovering from one.

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I am recommended to have additional chemotherapy after surgery for my cancer.

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My surgery did not remove all of my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Relapse Free Survival

Secondary study objectives

Number of adverse events

Overall survival

Rate of ctDNA clearance

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Nivolumab

2014

Completed Phase 3

~5220

Pemetrexed

2014

Completed Phase 3

~5550