Nonsmall Cell Lung Cancer Stage IIIPhase 2NCT05696782
Quick Start Durvalumab Following Chemoradiation for Stage III Nonsmall Cell Lung Cancer
A Phase 2 study testing Durvalumab, the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) and COPD Assessment Test (CAT) in people with Nonsmall Cell Lung Cancer Stage III and Unresectable Non-Small Cell Lung Carcinoma, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
This research study aims to determine what effects (good and bad) Durvalumab has on participants and their cancer with a "quick start" of Durvalumab within 14 days of finishing chemotherapy and radiation. The study will also determine the logistic barriers to the quick start of Durvalumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonsmall Cell Lung Cancer Stage III, Unresectable Non-Small Cell Lung Carcinoma, Nonsmall Cell Lung Cancer, Stage II
- What is being tested?
- Durvalumab, the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) and COPD Assessment Test (CAT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jul 2023to Apr 2027
- 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
- Patients must have stage II or stage III NSCLC confirmed by histologic or cytologic documentation and by clinical assessment. Staging is defined according to the AJCC Cancer Staging Manual, 8th Edition (2017).
- Unresectable or medically inoperable as determined by the investigator.
- The patient has definitive radiation therapy (e.g., 54 Gy to 66 Gy in 30 to 35 fractions) for lung cancer that is either (a) planned to start within the next 28 days, or (b) currently being administered, or (c) has been completed within the last 14 days.
- Platinum-based chemotherapy for lung cancer that is either (a) planned to start within the next 28 days, (b) currently being administered, or (c) has been completed within the last 14 days. Chemotherapy must be for at least two cycles and be administered either before radiation therapy ("induction" or "sequential") or during radiation therapy ("concurrent").
- Consolidation durvalumab is planned for NSCLC after radiation and chemotherapy.
- Eighteen years old or greater.
Show all 10Show fewer
- ECOG performance status of 0-2.
- Life expectancy of greater than three months.
- Patients with sexual relationships in which either they or their partner may become pregnant must use contraception during the study treatment period.
- Ability to understand and be willing to sign an IRB-approved informed consent document directly or via a legally authorized representative.
Who cannot join
- Uncontrolled respiratory symptoms (i.e., cough, dyspnea, fevers, chest pain, or an increase from baseline oxygen requirements) that are interfering with activities of daily living.
- Nonsmall cell lung cancer is known to have a tumor with a mutation in EGFR associated with sensitivity to first-line therapy with a tyrosine kinase inhibitor (i.e., Ex19del or L858R). Testing for EGFR mutation must have been attempted for study enrollment. If EGFR testing is inconclusive (e.g., the biopsy's quantity or quality is not sufficient for testing to be performed) and there is low clinical suspicion for the presence of an EGFR mutation as determined by the investigator, then the patient is eligible.
- Prior exposure to an immune checkpoint inhibitor targeting CTLA-4, PD-1, or PD-L1.
- Active autoimmune disease requiring systemic immunosuppression at the time of enrollment.
- History of autoimmune pneumonitis requiring high-dose systemic steroids (equivalent prednisone >20 mg/day for more than one week).
- Uncontrolled intercurrent illness includes ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients who are pregnant or breastfeeding.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Atrium Health Levine Cancer
Charlotte, North Carolina, 28204
Melani Terry, 704-574-2933, Melani.Terry@advocatehealth.org
Kathryn Mileham, MD
- Recruiting
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Jada Kluttz, 336-713-0901, Jada.Kluttz@Advocatehealth.org
Thomas Lycan, MD
About this study
Official title: Phase II Pilot Study of Quick Start Durvalumab Following Chemoradiation for Stage III Nonsmall Cell Lung Cancer
This research study aims to determine what effects (good and bad) Durvalumab has on participants and their cancer with a "quick start" of Durvalumab within 14 days of finishing chemotherapy and radiation. The study will also determine the logistic barriers to the quick start of Durvalumab.
Read the detailed description
Primary Objective: Assess the treatment fidelity for early Durvalumab initiation (i.e., within 14 days after the last day of radiation therapy) following chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer.
Secondary Objectives:
- Assess the treatment fidelity for very early Durvalumab initiation (i.e., within seven days after the last day of radiation therapy) following chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer.
- Assess barriers to earlier Durvalumab initiation following chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer.
- Describe the toxicity of Durvalumab when initiated quickly after chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer as compared to historical controls.
- Describe the efficacy of Durvalumab when initiated quickly after chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer as compared to historical controls.
- Conditions
- Nonsmall Cell Lung Cancer Stage III, Unresectable Non-Small Cell Lung Carcinoma, Nonsmall Cell Lung Cancer, Stage II
- Being tested
- Durvalumab, the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30), COPD Assessment Test (CAT), Modified Medical Research Council (mMRC) dyspnea scale
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Participants will receive Durvalumab 1500 mg intravenously every two weeks for 60 minutes. Each treatment is called a cycle and lasts for four weeks (or 28 days).
the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)Other
Participants will be asked to answer all 30 items on the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30). This patient-reported outcome measure is designed to measure cancer patients' physical, psychological and social functions. The measure can be completed using a paper form, by verbally providing answers to the study team, or by entering the answers online into REDCap using a computer or mobile device. The total time to complete the questionnaire is approximately 11 minutes (
COPD Assessment Test (CAT)Diagnostic test
Participants will be asked to answer all items on the COPD assessment test (8 items) and the patient-reported outcome measures designed to measure respiratory function. The measures can be completed using a paper form, by verbally providing answers to the study team, or by entering the answers online into REDCap using a computer or mobile device. The total time to complete the questionnaire is less than 5 minutes.
Modified Medical Research Council (mMRC) dyspnea scaleDiagnostic test
Participants will be asked to answer the modified medical research council dyspnea scale (1 item), and the patient-reported outcome measures designed to measure respiratory function. The measures can be completed using a paper form, by verbally providing answers to the study team, or by entering the answers online into REDCap using a computer or mobile device. The total time to complete the questionnaire is less than 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Quick Start Durvalumab | Experimental | Standard of care test and procedures for cancer treatments along with Durvalumab treatment at physician's discretion Receives: Drug: Durvalumab; Other: the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30); Diagnostic Test: COPD Assessment Test (CAT); Diagnostic Test: Modified Medical Research Council (mMRC) dyspnea scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants to Achieve Fidelity to Early Treatment with Durvalumab - Early Initiation (1-14 days)
Fidelity is defined as a dichotomous composite indicator (yes/no) that describes whether the patient received very early (1-7 days) or early (days 8-14 days) initiation of Durvalumab as per protocol with all four of the following criteria having been met: (i) CT chest obtained after the last day of radiation therapy and before the first infusion of Durvalumab, (ii) first infusion within 14 days of completing radiation therapy, (iii) second and third doses received within 63 days of the first dose, and (iv) all infusions at least 28 days apart.
Measured: 48 weeks
Secondary outcomes (10)
Number of Participants to Achieve Fidelity to Early Treatment with Durvalumab - Very Early (1-7 days)
Fidelity is defined as a dichotomous composite indicator (yes/no) that describes whether the patient received very early (1-7 days) initiation of Durvalumab as per protocol with all four of the following criteria having been met: (i) CT chest obtained after the last day of radiation therapy and before the first infusion of Durvalumab, (ii) first infusion within 7 days of completing radiation therapy, (iii) second and third doses received within 63 days of the first dose, and (iv) all infusions at least 28 days apart.
Measured: Up to 13 months
Number of Barriers to Initiation of Durvalumab - Very Early (Days 1-7)
Assess the barriers to the very early (1-7 days) initiation of durvalumab using a survey and free text reporting by study personnel and participants. Descriptive frequencies of participant survey answers will be examined to conduct qualitative analyses and determine appropriate categories of answers on the free text responses. We will examine barriers/obstacles for everyone in the sample, even those who achieve fidelity; such patients could have experienced delays even if they were still able to achieve fidelity. We will stratify answers/responses by fidelity status.
Measured: Up to 13 months
Number of Barriers to Initiation of Durvalumab - Early (Days 8-14)
Assess the barriers to the early (8-14 days) initiation of durvalumab using a survey and free text reporting by study personnel and participants. Descriptive frequencies of participant survey answers will be examined to conduct qualitative analyses and determine appropriate categories of answers on the free text responses. We will examine barriers/obstacles for everyone in the sample, even those who achieve fidelity; such patients could have experienced delays even if they were still able to achieve fidelity. We will stratify answers/responses by fidelity status.
Measured: Up to 13 months
Number of Participants with All Adverse Events
The number of participants with adverse events, serious adverse events, and immune-related adverse events (irAEs) within 85 days (i.e., 1-3 cycles) of the first infusion of durvalumab.
Measured: Within 85 days of intervention (Cycles 1-3)
Number of Participants Who Have Immune-Mediated Pneumonitis
The proportion of patients who have immune-mediated pneumonitis (i.e., excluding pneumonitis due to radiation), any grade, and early onset (i.e., within 85 days [1-3 cycles]).
Measured: Within 85 days of intervention (Cycles 1-3)
Number of Participants Who Have All-Cause Any Grade Pneumonitis
Participants with all-cause any-grade pneumonitis and early onset.
Measured: Within 85 days of intervention (Cycles 1-3)
Number of Participants to Discontinue Durvalumab Due to Adverse Events
Participants who discontinue Durvalumab at any point due to an adverse event of any cause.
Measured: One year
Overall Survival
Using Kaplan-Meier life table methods, overall survival is defined as the number of participants alive at 12 months after the first dose of Durvalumab.
Measured: One year
Progression-Free Survival
Using Kaplan-Meier methods, progression-free survival is defined as the number of participants alive and without disease progression as documented by the treating provider at 12 months after the first dose of Durvalumab.
Measured: One year
Response Rate
Best objective response rate (ORR) to Durvalumab is defined by either a complete response (CR) or partial response (PR) as per RECIST 1.1 criteria by investigator assessment and confirmed on at least two sequential imaging studies that are at least four weeks apart.
- Complete Response (CR): Disappearance of all target lesions.
- Partial Response (PR): Decrease by ≥ 30% in sum of longest diameter of target lesions.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start26 Jul 2023
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsmall Cell Lung Cancer Stage IIIStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Thomas Lycan, MD, Principal investigator, Wake Forest Baptist Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696782
- Sponsor's protocol ID
- IRB00092850
- Other IDs
- WFBCCC 62422, P30CA012197
- Status last verified
- Jul 2026
- First submitted
- 12 Jan 2023
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Study of Quick Start Durvalumab Following Chemoradiation for Stage III Nonsmall Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05696782
- Acronym / sponsor ID
- IRB00092850
- Conditions
- Nonsmall Cell Lung Cancer Stage III, Unresectable Non-Small Cell Lung Carcinoma, Nonsmall Cell Lung Cancer, Stage II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 25 Jan 2023 (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.
This research study aims to determine what effects (good and bad) Durvalumab has on participants and their cancer with a "quick start" of Durvalumab within 14 days of finishing chemotherapy and radiation. The study will also determine the logistic barriers to the quick start of Durvalumab.
Detailed description
Primary Objective: Assess the treatment fidelity for early Durvalumab initiation (i.e., within 14 days after the last day of radiation therapy) following chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer.
Secondary Objectives:
- Assess the treatment fidelity for very early Durvalumab initiation (i.e., within seven days after the last day of radiation therapy) following chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer.
- Assess barriers to earlier Durvalumab initiation following chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer.
- Describe the toxicity of Durvalumab when initiated quickly after chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer as compared to historical controls.
- Describe the efficacy of Durvalumab when initiated quickly after chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer as compared to historical controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quick Start Durvalumab | Experimental | Drug: Durvalumab, Other: the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30), Diagnostic Test: COPD Assessment Test (CAT), Diagnostic Test: Modified Medical Research Council (mMRC) dyspnea scaleStandard of care test and procedures for cancer treatments along with Durvalumab treatment at physician's discretion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have stage II or stage III NSCLC confirmed by histologic or cytologic documentation and by clinical assessment. Staging is defined according to the AJCC Cancer Staging Manual, 8th Edition (2017).
- Unresectable or medically inoperable as determined by the investigator.
- The patient has definitive radiation therapy (e.g., 54 Gy to 66 Gy in 30 to 35 fractions) for lung cancer that is either (a) planned to start within the next 28 days, or (b) currently being administered, or (c) has been completed within the last 14 days.
- Platinum-based chemotherapy for lung cancer that is either (a) planned to start within the next 28 days, (b) currently being administered, or (c) has been completed within the last 14 days. Chemotherapy must be for at least two cycles and be administered either before radiation therapy ("induction" or "sequential") or during radiation therapy ("concurrent").
- Consolidation durvalumab is planned for NSCLC after radiation and chemotherapy.
Key exclusion criteria (7 listed)
- Uncontrolled respiratory symptoms (i.e., cough, dyspnea, fevers, chest pain, or an increase from baseline oxygen requirements) that are interfering with activities of daily living.
- Nonsmall cell lung cancer is known to have a tumor with a mutation in EGFR associated with sensitivity to first-line therapy with a tyrosine kinase inhibitor (i.e., Ex19del or L858R). Testing for EGFR mutation must have been attempted for study enrollment. If EGFR testing is inconclusive (e.g., the biopsy's quantity or quality is not sufficient for testing to be performed) and there is low clinical suspicion for the presence of an EGFR mutation as determined by the investigator, then the patient is eligible.
- Prior exposure to an immune checkpoint inhibitor targeting CTLA-4, PD-1, or PD-L1.
- Active autoimmune disease requiring systemic immunosuppression at the time of enrollment.
- History of autoimmune pneumonitis requiring high-dose systemic steroids (equivalent prednisone >20 mg/day for more than one week).
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 |
|---|---|---|
| DurvalumabParticipants will receive Durvalumab 1500 mg intravenously every two weeks for 60 minutes. Each treatment is called a cycle and lasts for four weeks (or 28 days). | Drug | Quick Start Durvalumab |
| the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)Participants will be asked to answer all 30 items on the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30). This patient-reported outcome measure is designed to measure cancer patients' physical, psychological and social functions. The measure can be completed using a paper form, by verbally providing answers to the study team, or by entering the answers online into REDCap using a computer or mobile device. The total time to complete the questionnaire is approximately 11 minutes ( | Other | Quick Start Durvalumab |
| COPD Assessment Test (CAT)Participants will be asked to answer all items on the COPD assessment test (8 items) and the patient-reported outcome measures designed to measure respiratory function. The measures can be completed using a paper form, by verbally providing answers to the study team, or by entering the answers online into REDCap using a computer or mobile device. The total time to complete the questionnaire is less than 5 minutes. | Diagnostic test | Quick Start Durvalumab |
| Modified Medical Research Council (mMRC) dyspnea scaleParticipants will be asked to answer the modified medical research council dyspnea scale (1 item), and the patient-reported outcome measures designed to measure respiratory function. The measures can be completed using a paper form, by verbally providing answers to the study team, or by entering the answers online into REDCap using a computer or mobile device. The total time to complete the questionnaire is less than 5 minutes. | Diagnostic test | Quick Start Durvalumab |
Primary outcome
Number of Participants to Achieve Fidelity to Early Treatment with Durvalumab - Early Initiation (1-14 days)
Time frame: 48 weeks
Fidelity is defined as a dichotomous composite indicator (yes/no) that describes whether the patient received very early (1-7 days) or early (days 8-14 days) initiation of Durvalumab as per protocol with all four of the following criteria having been met: (i) CT chest obtained after the last day of radiation therapy and before the first infusion of Durvalumab, (ii) first infusion within 14 days of completing radiation therapy, (iii) second and third doses received within 63 days of the first dose, and (iv) all infusions at least 28 days apart.
10 secondary outcomes
Number of Participants to Achieve Fidelity to Early Treatment with Durvalumab - Very Early (1-7 days)
Time frame: Up to 13 months
Number of Barriers to Initiation of Durvalumab - Very Early (Days 1-7)
Time frame: Up to 13 months
Number of Barriers to Initiation of Durvalumab - Early (Days 8-14)
Time frame: Up to 13 months
Number of Participants with All Adverse Events
Time frame: Within 85 days of intervention (Cycles 1-3)
Number of Participants Who Have Immune-Mediated Pneumonitis
Time frame: Within 85 days of intervention (Cycles 1-3)
Number of Participants Who Have All-Cause Any Grade Pneumonitis
Time frame: Within 85 days of intervention (Cycles 1-3)
Number of Participants to Discontinue Durvalumab Due to Adverse Events
Time frame: One year
Overall Survival
Time frame: One year
Progression-Free Survival
Time frame: One year
Response Rate
Time frame: One year
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 22 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Thomas Lycan, MD principal investigator
Wake Forest Baptist Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab, the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) and COPD Assessment Test (CAT) in people with Nonsmall Cell Lung Cancer Stage III and Unresectable Non-Small Cell Lung Carcinoma, run by Wake Forest University Health Sciences at 2 sites in United States.
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 10 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jada Kluttz (336-713-0901, Jada.Kluttz@Advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants to Achieve Fidelity to Early Treatment with Durvalumab - Early Initiation (1-14 days) (time frame: 48 weeks). 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 22 Sep 2026.