Non-small Cell Lung CancerPhase 1/2NCT05451173
Combining ICI With SBRT or HypoFrx-RT for ES NSCLC
A Phase 1/2 study testing Stereotactic body radiotherapy, Hypofractionated radiotherapy and Durvalumab in people with Non-small Cell Lung Cancer and Non-small Cell Carcinoma, run by Alexander Chi at 1 site in China.
Trial summary
This study will explore the best dose of radiation to be used when treating stage I-III non-small cell lung cancer (NSCLC) with stereotactic body radiation therapy (SBRT) or hypo-fractionated radiotherapy (HypoFrx-RT) that is delivered in combination with an immune checkpoint inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-small Cell Lung Cancer, Non-small Cell Carcinoma, Non-small Cell Lung Cancer Stage I
- What is being tested?
- Stereotactic body radiotherapy, Hypofractionated radiotherapy and Durvalumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2023to 31 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed Consent
- Stage I-III NSCLC per AJCC 8th. ed.
- Tumor PD-L1 expression ≥1% preferred
- Tumor sample submission
- Tumor staging prior to registration
- Age ≥ 18 years
Show all 10Show fewer
- WHO/ECOG PS of 0, 1, or 2
- Life expectancy ≥12 weeks
- Adequate organ or bone marrow function
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.
Who cannot join
- Mixed small cell and non-small cell lung cancer histology
- Definitive clinical or radiologic evidence of metastatic disease
- Patients who received systemic therapy for the current cancer prior to enrollment
- Thoracic radiotherapy within 5 years with exceptions
- Major surgery within 28 days prior to enrollment with exception
- Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
Show all 11Show fewer
- History of another primary malignancy with exceptions
- History of idiopathic pulmonary fibrosis, any pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on chest PET/CT or CT scan
- Active or prior documented autoimmune disease with exceptions
- History of primary immunodeficiency
- History of allogenic organ or tissue transplantation
Trial locations and contacts
1 site in 1 country.
China1 site
Capital Medical University Xuanwu Hospital
Beijing, Beijing Municipality, 100053
Alexander Chi, 18701866689
About this study
Official title: Combining an Immune Checkpoint Inhibitor With SBRT or Hypo-fractionated RT in the Treatment of Stage I-III NSCLC: an Exploratory Study on Radiation Dose and Treatment Efficacy.
This study will explore the best dose of radiation to be used when treating stage I-III non-small cell lung cancer (NSCLC) with stereotactic body radiation therapy (SBRT) or hypo-fractionated radiotherapy (HypoFrx-RT) that is delivered in combination with an immune checkpoint inhibitor. Treatments with SBRT or HypoFrx-RT for locally confined NSCLC show positive response which may be further augmented when they are combined with an immune checkpoint inhibitor. Currently, it is not understood what radiation dose is most suitable for such combined treatments and their clinical efficacy in the treatment of early stage (ES) NSCLC. Therefore, this study can help researchers gain insight into what a safe and effective SBRT or HypoFrx-RT dose will be when such radiotherapeutic approaches are combined with concurrent and adjuvant administration of an immune checkpoint inhibitor in the treatment of ES NSCLC.
Read the detailed description
Patients will be assigned to Cohort A or Cohort B based on tumor stage (AJCC 8th Ed.).
Cohort A: cT1-T3, N0, M0 (selected cT1, No, M0)
Cohort B: cT4, N0, M0; cT1-4, N1-3, M0
Phase I:
This portion of the study will utilize a standard 3 + 3 phase I design with three patients enrolled per radiation dose level in each cohort. Enrollment in the two cohorts is independent from one another. In both cohorts, an anti-PD-(L)1 immune checkpoint inhibitor will be given concurrently and adjuvantly with radiotherapy for approximately 1 year.
The radiation dose escalation for each cohort is listed below:
Cohort A (SBRT):
(Optional): 8 Gy x 5 daily fractions
Level 1: 9 Gy x 5 daily fractions
Level 2: 10 Gy x 5 daily fractions
Level 3: 11 Gy x 5 daily fractions
Cohort B (HypoFrx-RT):
(Optional): 3 Gy x 15 daily fractions
Level 1: 3.5 Gy x 15 daily fractions
Level 2: 4 Gy x 15 daily fractions
DLTs will be based on events occurring during the course of radiotherapy.
Concurrent administration of an immune checkpoint inhibitor is defined as:
An anti-PD-(L)1 immune checkpoint inhibitor administered with standard dosing (Durvalumab: 1500 mg every 4 weeks) given within 5 days prior to the beginning of radiotherapy.
Adjuvant administration of an immune checkpoint inhibitor is defined as:
An anti-PD-(L)1 immune checkpoint inhibitor administered with standard dosing (Durvalumab: 1500 mg every 4 weeks) for approximately 1 year or until progression or other discontinuation criteria are met.
Phase II:
Once a maximum tolerated dose (MTD) is defined in each cohort, this dose will be used as the only radiation dose in each corresponding cohort in the phase II portion of this study. Dosing regimen of the immune checkpoint inhibitor will remain the same as that used in the phase I portion of this study.
For this protocol, patients will be followed up to 2 years after the last dose of immune checkpoint inhibitor is administered.
- Conditions
- Non-small Cell Lung Cancer, Non-small Cell Carcinoma, Non-small Cell Lung Cancer Stage I, Non-small Cell Lung Cancer Stage II, Non-small Cell Lung Cancer Stage III
- Being tested
- Stereotactic body radiotherapy, Hypofractionated radiotherapy, Durvalumab
- Keywords
- NSCLC, Stereotactic body radiotherapy, SBRT, Hypofractionated, Radiotherapy
- 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.
Stereotactic body radiotherapyRadiation
Also called SBRT
An ablative dose of radiation is delivered to the primary tumor target over 1-2 week.
Hypofractionated radiotherapyRadiation
Also called HypoFrx-RT
Hypofractionated radiotherapy is delivered to the primary tumor and any involved lymph node target(s) over 3 weeks.
DurvalumabDrug
an anti-PD-(L)1 immune checkpoint inhibitor is administered concurrently and adjuvantly with radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | SBRT to be delivered with concurrent and adjuvant anti-PD-(L)1 immune checkpoint inhibitor. Receives: Radiation: Stereotactic body radiotherapy; Drug: Durvalumab |
| Cohort B | Experimental | Hypo-fractionated radiotherapy to be delivered with concurrent and adjuvant anti-PD-(L)1 immune checkpoint inhibitor. Receives: Radiation: Hypofractionated radiotherapy; Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
MTD in cohort A and cohort B, respectively.
Measured: 2 years
The incidence of any adverse events that is >= grade 3
Adverse events will be graded according to CTCAE v.5.0
Measured: 2 years
Progression-free survival (PFS)
PFS is defined as free from any disease progression or death after combined treatment for NSCLC.
Measured: 2 years
Secondary outcomes (4)
Local control
To report the local control rate along with the rate of regional control and distant metastasis after combined treatment for NSCLC.
Measured: 2 years
Overall survival (OS)
To report OS after combined treatment
Measured: 2 years
Quality of Life (QoL)
To determine the QoL pertaining to any cancer patients before and after treatment using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) scales.
Measured: 2 years
Quality of Life (QoL), Lung cancer specific
To determine the QoL before and after treatment using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire that is specific to lung cancer patients, the Lung Cancer 29(LC 29) scoring scales.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start9 Oct 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexander Chi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexander Chi, Xuanwu Hospital, Beijing
- Investigators
- Alexander Chi, MD, Study chair, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451173
- Sponsor's protocol ID
- SF 2022-2-1042
- Status last verified
- Sep 2023
- First submitted
- 29 Jun 2022
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining an Immune Checkpoint Inhibitor With SBRT or Hypo-fractionated RT in the Treatment of Stage I-III NSCLC: an Exploratory Study on Radiation Dose and Treatment Efficacy.
- ClinicalTrials.gov ID
- NCT05451173
- Acronym / sponsor ID
- SF 2022-2-1042
- Conditions
- Non-small Cell Lung Cancer, Non-small Cell Carcinoma, Non-small Cell Lung Cancer Stage I, Non-small Cell Lung Cancer Stage II, Non-small Cell Lung Cancer Stage III
- Keywords
- NSCLC, Stereotactic body radiotherapy, SBRT, Hypofractionated, Radiotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Alexander ChiUniversity, hospital or other
- Study start
- 9 Oct 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Jul 2022 (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 study will explore the best dose of radiation to be used when treating stage I-III non-small cell lung cancer (NSCLC) with stereotactic body radiation therapy (SBRT) or hypo-fractionated radiotherapy (HypoFrx-RT) that is delivered in combination with an immune checkpoint inhibitor. Treatments with SBRT or HypoFrx-RT for locally confined NSCLC show positive response which may be further augmented when they are combined with an immune checkpoint inhibitor. Currently, it is not understood what radiation dose is most suitable for such combined treatments and their clinical efficacy in the treatment of early stage (ES) NSCLC. Therefore, this study can help researchers gain insight into what a safe and effective SBRT or HypoFrx-RT dose will be when such radiotherapeutic approaches are combined with concurrent and adjuvant administration of an immune checkpoint inhibitor in the treatment of ES NSCLC.
Detailed description
Patients will be assigned to Cohort A or Cohort B based on tumor stage (AJCC 8th Ed.).
Cohort A: cT1-T3, N0, M0 (selected cT1, No, M0)
Cohort B: cT4, N0, M0; cT1-4, N1-3, M0
Phase I:
This portion of the study will utilize a standard 3 + 3 phase I design with three patients enrolled per radiation dose level in each cohort. Enrollment in the two cohorts is independent from one another. In both cohorts, an anti-PD-(L)1 immune checkpoint inhibitor will be given concurrently and adjuvantly with radiotherapy for approximately 1 year.
The radiation dose escalation for each cohort is listed below:
Cohort A (SBRT):
(Optional): 8 Gy x 5 daily fractions
Level 1: 9 Gy x 5 daily fractions
Level 2: 10 Gy x 5 daily fractions
Level 3: 11 Gy x 5 daily fractions
Cohort B (HypoFrx-RT):
(Optional): 3 Gy x 15 daily fractions
Level 1: 3.5 Gy x 15 daily fractions
Level 2: 4 Gy x 15 daily fractions
DLTs will be based on events occurring during the course of radiotherapy.
Concurrent administration of an immune checkpoint inhibitor is defined as:
An anti-PD-(L)1 immune checkpoint inhibitor administered with standard dosing (Durvalumab: 1500 mg every 4 weeks) given within 5 days prior to the beginning of radiotherapy.
Adjuvant administration of an immune checkpoint inhibitor is defined as:
An anti-PD-(L)1 immune checkpoint inhibitor administered with standard dosing (Durvalumab: 1500 mg every 4 weeks) for approximately 1 year or until progression or other discontinuation criteria are met.
Phase II:
Once a maximum tolerated dose (MTD) is defined in each cohort, this dose will be used as the only radiation dose in each corresponding cohort in the phase II portion of this study. Dosing regimen of the immune checkpoint inhibitor will remain the same as that used in the phase I portion of this study.
For this protocol, patients will be followed up to 2 years after the last dose of immune checkpoint inhibitor is administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Radiation: Stereotactic body radiotherapy, Drug: DurvalumabSBRT to be delivered with concurrent and adjuvant anti-PD-(L)1 immune checkpoint inhibitor. |
| Cohort B | Experimental | Radiation: Hypofractionated radiotherapy, Drug: DurvalumabHypo-fractionated radiotherapy to be delivered with concurrent and adjuvant anti-PD-(L)1 immune checkpoint inhibitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Informed Consent
- Stage I-III NSCLC per AJCC 8th. ed.
- Tumor PD-L1 expression ≥1% preferred
- Tumor sample submission
- Tumor staging prior to registration
Key exclusion criteria (11 listed)
- Mixed small cell and non-small cell lung cancer histology
- Definitive clinical or radiologic evidence of metastatic disease
- Patients who received systemic therapy for the current cancer prior to enrollment
- Thoracic radiotherapy within 5 years with exceptions
- Major surgery within 28 days prior to enrollment with exception
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 |
|---|---|---|
| Stereotactic body radiotherapyAlso: SBRTAn ablative dose of radiation is delivered to the primary tumor target over 1-2 week. | Radiation | Cohort A |
| Hypofractionated radiotherapyAlso: HypoFrx-RTHypofractionated radiotherapy is delivered to the primary tumor and any involved lymph node target(s) over 3 weeks. | Radiation | Cohort B |
| Durvalumaban anti-PD-(L)1 immune checkpoint inhibitor is administered concurrently and adjuvantly with radiotherapy. | Drug | Cohort A, Cohort B |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: 2 years
MTD in cohort A and cohort B, respectively.
The incidence of any adverse events that is >= grade 3
Time frame: 2 years
Adverse events will be graded according to CTCAE v.5.0
Progression-free survival (PFS)
Time frame: 2 years
PFS is defined as free from any disease progression or death after combined treatment for NSCLC.
4 secondary outcomes
Local control
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Quality of Life (QoL)
Time frame: 2 years
Quality of Life (QoL), Lung cancer specific
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- 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. This study is not recruiting at the moment.
Alexander Chi, MD study chair
Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stereotactic body radiotherapy, Hypofractionated radiotherapy and Durvalumab in people with Non-small Cell Lung Cancer and Non-small Cell Carcinoma, run by Alexander Chi at 1 site in China.
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 11 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: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Chi, MD (5718391855, achiaz2010@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: 2 years). The study lists 3 primary outcomes in all. 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 3 Oct 2023.