Using ctDNA to Determine Therapies for Lung Cancer

Sponsor
University Health Network, Toronto
Study ID
NCT04966663
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Antineoplastic agent
  • Pemetrexed — DRUG
    Antineoplastic agent
  • Gemcitabine — DRUG
    Antineoplastic agent
  • Cisplatin — DRUG
    Antineoplastic agent
  • Carboplatin — DRUG
    Antineoplastic agent
  • ctDNA blood test — PROCEDURE
    Blood will be collected for ctDNA testing

Study Details

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.

Key Dates

Start date
Mar 28, 2022
Status verified
Dec 2025
Primary completion
Aug 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • Other: Observation
    All participants will have blood taken for ctDNA testing. Participants will be followed as per standard of care every 3 months.

Primary Outcome Measure

Relapse Free Survival [ Time Frame: 2 years ]

Central Contacts

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