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CLEAR-Lung III: Circulating Tumor DNA-Guided Consolidation Chemotherapy and Immunotherapy

ConditionLung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnusha Chidharla, MD

About this trial

CLEAR LUNG-III is a single-arm, phase II study evaluating a circulating tumor DNA (ctDNA)-guided treatment strategy in patients with unresectable stage III non-small cell lung cancer who have completed definitive chemoradiation and are receiving consolidation immunotherapy.

Patients with persistent molecular residual disease (MRD) by tumor-informed ctDNA assay will receive consolidation chemotherapy intensification in addition to standard immunotherapy, with the goal of improving molecular response.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability of participant to understand this study, and participant willingness to sign a written informed consent.

Stated willingness to comply with all study procedures / study intervention regimen and availability for the duration of the study

Males and females age ≥ 18 years

Histologically or cytologically confirmed unresectable Stage III NSCLC

Disqualifiers

Prior neoadjuvant chemotherapy.

Concurrent or planned use of other anti-neoplastic or investigational agents during study participation.

Absence of post-chemoradiation ctDNA results

Radiographic evidence of disease progression on CT and/or PET/CT imaging within 6 weeks following completion of definitive concurrent chemoradiation

Trial design

Design model

Single group

Treatments tested in this trial

  • Consolidation Chemotherapy

    Drug

    Consolidation chemotherapy intensification in addition to standard immunotherapy. Carboplatin + pemetrexed for non-squamous histology - up to 3 cycles (9 weeks) Carboplatin + paclitaxel for squamous histology - up to 3 cycles (9 weeks) Durvalumab - for total of 1 year NOTE: Durvalumab administration begins at the same time as chemotherapy (can be started earlier if needed).

Treatment groups

43 Participants
are divided into 1 treatment group
Group A: Treatment ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

MRD (ctDNA) Clearance

Treatment response, defined as MRD (ctDNA) clearance, measured as undetectable ctDNA at 12 weeks(±14 days), after initiation of chemotherapy plus durvalumab in patients with MRD-positive unresectable Stage III NSCLC after definitive chemoradiation. MRD clearance is a validated surrogate for recurrence risk and survival.

Time frame
Approximately 12 weeks after initiation of consolidation chemotherapy (±14 days)

Secondary outcomes

1

Disease Control Rate (DCR)

Disease Control Rate (DCR) is defined as the proportion of enrolled patients who achieve complete response (CR), partial response (PR), or stable disease (SD) as their best overall response, assessed by imaging per RECIST v1.1.

Time frame
Approximately 1 year
2

Progression-Free Survival (PFS)

Progression Free Survival (PFS) will be defined as the time from initiation of treatment to first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first. PFS will be summarized using Kaplan-Meier methods, and the 1-year PFS rate with 95% confidence interval will be estimated.

Time frame
Approximately 1 year
3

Overall Survival (OS)

Overall Survival (OS) is defined as the time from initiation of treatment to death from any cause. Patients who are alive at the time of analysis will be censored at the date of last known follow-up. OS will be summarized using Kaplan-Meier methods, and the 1-year OS rate with 95% confidence interval will be estimated.

Time frame
Approximately 1 year
4

Time to Radiographic Progression

Interval between ctDNA detection and radiographic evidence of disease. Measured by serial ctDNA assessments and radiographic imaging per RECIST 1.1. Kaplan-Meier analysis will be used to estimate time-to-event endpoints.

Time frame
Approximately 1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Anusha Chidharla, MD

Lead sponsor

University of Kansas Medical Center

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: