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Using ctDNA to Determine Therapies for Lung Cancer

ConditionsNon Small Cell Lung CancerComplete Surgical ResectionCirculating Tumor DNA
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years at the time of screening

Written informed consent obtained from the subject prior to performing any protocol-related procedures

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Weight ≥ 35 kg

Disqualifiers

Participants that should receive adjuvant chemotherapy per standard of care (resected N1 or N2 disease, primary tumour >=4 cm).

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 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;

Incomplete surgical resection;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nivolumab

    Drug

    Antineoplastic agent

  • Pemetrexed

    Drug

    Antineoplastic agent

  • Gemcitabine

    Drug

    Antineoplastic agent

  • Cisplatin

    Drug

    Antineoplastic agent

  • Carboplatin

    Drug

    Antineoplastic agent

  • ctDNA blood test

    Procedure/Surgery

    Blood will be collected for ctDNA testing

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Adjuvant chemo-immunotherapy therapyExperimental treatment 6 interventions
Group B: ObservationOther 1 intervention

Trial outcomes

Primary outcomes

1

Relapse Free Survival

To demonstrate the impact of intensified adjuvant therapy on relapse-free survival (RFS) in patients at high risk of relapse post-resection identified by pre- or post-operative detectable ctDNA plasma levels in patients with resected T1-T4 (T3-4 multifocal only) N0M0 NSCLC.

Time frame
2 years

Secondary outcomes

1

Rate of ctDNA clearance

To estimate and compare the ctDNA detection rates at 12 weeks post-randomization in those receiving adjuvant chemo-immunotherapy versus observation.

Time frame
12 weeks
2

Overall survival

To compare overall survival (OS) of patients receiving adjuvant chemo-immunotherapy versus observation.

Time frame
3 years
3

Number of adverse events

To determine safety and tolerability of adjuvant chemo-immunotherapy with the combination of nivolumab with cisplatin and pemetrexed or nivolumab with cisplatin and gemcitabine.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov
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