Lung CancerPhase 2NCT07858253
CLEAR-Lung III: Circulating Tumor DNA-Guided Consolidation Chemotherapy and Immunotherapy
A Phase 2 study testing Consolidation Chemotherapy in people with Lung Cancer, run by Anusha Chidharla, MD.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Consolidation Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Oct 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Completion of definitive concurrent chemoradiation (CRT) within 6 weeks prior to enrollment/registration
- MRD-positive status confirmed by a validated circulating tumor DNA (ctDNA) assay within 6 weeks following chemoradiation
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- Eastern Cooperative Oncology Groug (ECOG) Performance Status (PS): 0 - 2 (Appendix A)
- Availability of archival tumor tissue for tumor-informed ctDNA assay, or eligibility for a validated plasma-only ctDNA panel if tumor tissue is unavailable.
- Patients with a prior or concurrent malignancy are eligible provided the malignancy is not expected to interfere with study treatment, safety assessment, or interpretation of study endpoints, in the opinion of the treating investigator
- Females of childbearing potential must have a negative serum or urine pregnancy test 48 hours prior to initiating treatment.
- Females of child-bearing potential and males with partners of child-bearing potential must agree not to donate sperm, to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section for the duration of study participation and :
- Females: for 6 months after the last dose of the study medication.
- Males: for 3 months after the last dose of the study medication.
- Adequate organ function, defined as follows:
- Leukocytes > 1.5 × 10⁹/L
- Absolute Neutrophil Count (ANC) > 1.5 × 10⁹/L Note: Patients with benign neutropenia may be eligible with ANC 1000-1500 if deemed safe by the treating physician.
- Platelets > 100 × 10⁹/L
- Hemoglobin ≥ 9 g/dL
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault)
- Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ 1 × ULN
- AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases present)
Who cannot join
- 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
- Presence of known sensitizing genomic alterations, including EGFR mutations or ALK rearrangements..
- Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
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- Currently pregnant or breastfeeding
- Has a known allergic reaction to any excipient contained in the study drug formulation
- Patients with a prior or concurrent malignancy are eligible provided the malignancy is not expected to interfere with study treatment, safety assessment, or interpretation of study endpoints, in the opinion of the treating investigator
- Any condition, diagnosis, or physical exam finding that, in the opinion of the investigator, would pose excessive risk or interfere with study participation
- Known history of autoimmune disease requiring systemic immunosuppression (if applicable to durvalumab safety profile)
- Has not had ctDNA testing prior to study enrollment
- Known history of interstitial lung disease or pneumonitis requiring steroids (if applicable)
- Known active hepatitis B, hepatitis C, or HIV infection with uncontrolled viral load or clinically significant active disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: CLEAR-Lung III: Circulating Tumor DNA-Guided Consolidation Chemotherapy and Immunotherapy After Chemoradiation in Unresectable Stage III NSCLC
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.
- Conditions
- Lung Cancer
- Being tested
- Consolidation Chemotherapy
- Keywords
- NSCLC, lung cancer, stage III, chemotherapy, immunotherapy, chemoradiation, ctDNA, circulating tumor DNA, MRD, minimum residual disease
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consolidation ChemotherapyDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Drug: Consolidation Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 12 weeks after initiation of consolidation chemotherapy (±14 days)
Secondary outcomes (5)
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.
Measured: Approximately 1 year
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.
Measured: Approximately 1 year
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.
Measured: Approximately 1 year
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.
Measured: Approximately 1 year
Incidence of Adverse Events (AE)
Frequency of Grade ≥3 treatment-related adverse events as assessed by CTCAE v 6.0.
Measured: Approximately 30 days (From start of intensification to 30 days post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anusha Chidharla, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anusha Chidharla, MD, University of Kansas Medical Center
- Investigators
- Anusha Chidharla, MD, Principal investigator, The University of Kansas Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858253
- Sponsor's protocol ID
- STUDY00162742
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLEAR-Lung III: Circulating Tumor DNA-Guided Consolidation Chemotherapy and Immunotherapy After Chemoradiation in Unresectable Stage III NSCLC
- ClinicalTrials.gov ID
- NCT07858253
- Acronym / sponsor ID
- STUDY00162742
- Conditions
- Lung Cancer
- Keywords
- NSCLC, lung cancer, stage III, chemotherapy, immunotherapy, chemoradiation, ctDNA, circulating tumor DNA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Anusha Chidharla, MDUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Consolidation Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
- Completion of definitive concurrent chemoradiation (CRT) within 6 weeks prior to enrollment/registration
Key exclusion criteria (14 listed)
- 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
- Presence of known sensitizing genomic alterations, including EGFR mutations or ALK rearrangements..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consolidation ChemotherapyConsolidation 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). | Drug | Treatment Arm |
Primary outcome
MRD (ctDNA) Clearance
Time frame: Approximately 12 weeks after initiation of consolidation chemotherapy (±14 days)
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.
5 secondary outcomes
Disease Control Rate (DCR)
Time frame: Approximately 1 year
Progression-Free Survival (PFS)
Time frame: Approximately 1 year
Overall Survival (OS)
Time frame: Approximately 1 year
Time to Radiographic Progression
Time frame: Approximately 1 year
Incidence of Adverse Events (AE)
Time frame: Approximately 30 days (From start of intensification to 30 days post-treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anusha Chidharla, MD principal investigator
The University of Kansas Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Consolidation Chemotherapy in people with Lung Cancer, run by Anusha Chidharla, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Mapson ((913) 574-0505, ejennings2@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRD (ctDNA) Clearance (time frame: Approximately 12 weeks after initiation of consolidation chemotherapy (±14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.