Carcinoma, Non-Small-Cell LungPhase 2NCT04255836
Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Durvalumab, the first line chemotherapy for metastatic NSCLC and stereotactic body radiotherapy (SBRT) in people with Carcinoma, Non-Small-Cell Lung, run by Zhejiang Cancer Hospital.
Trial summary
This is a Phase II, multi-center pilot study assessing the efficacy and safety of durvalumab combined with chemotherapy and stereotactic body radiotherapy (SBRT) in patients with oligo-metastatic non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Durvalumab, the first line chemotherapy for metastatic NSCLC and stereotactic body radiotherapy (SBRT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2020to 30 Jul 2023
- Phase
- Phase 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed non-small cell lung cancer
- ≤3 metastatic organs and ≤5 metastatic lesions (supraclavicular and mediastinal lymph nodes are not classified as distant metastasis; other lymph node
- metastasis一group lymph node region will be classified as one metastatic lesion）
- Tissue biopsy prior to treatment
- ECOG performance score 0-1
Who cannot join
- EGFR mutation or ALK positive.
- Evidence on pulmonary interstitial disease or symptoms of active non-infectious pneumonia.
- Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
- Previous treatment with antibody against pd -1, pd - L1, pd - L2, CD137 or CTLA-4 (including ipilimumab or any antibody or drug against T cell co-stimulation or checkpoint pathway).
About this study
Official title: A Pilot Study of Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)
This is a Phase II, multi-center pilot study assessing the efficacy and safety of durvalumab combined with chemotherapy and stereotactic body radiotherapy (SBRT) in patients with oligo-metastatic non-small cell lung cancer (NSCLC).
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Durvalumab, the first line chemotherapy for metastatic NSCLC, stereotactic body radiotherapy (SBRT)
- 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
Also called IMFINZI
Durvalumab 1500mg q3w combined with chemotherapy for 4 cycles, then 1500mg q4w combined with SBRT, then 1500mg q4w for PD or up to 24 months
the first line chemotherapy for metastatic NSCLCDrug
paclitaxel+carboplatin or pemetrexed+cisplatin
stereotactic body radiotherapy (SBRT)Radiation
SBRT total doses of 50-60Gy/≤10F
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab therapy | Experimental | Chemo+Durvalumab (PD-L1 monoclonal antibody)1500 mg every 3 weeks [q3w] intravenously [iv] for 4 cycles, then SBRT 50-60 Gy/≤10f + Durvalumab 1500 mg q4w, then Durvalumab 1500 mg q4w for up to 24 months or until progression or other discontinuation criteria are met. Receives: Drug: Durvalumab; Drug: the first line chemotherapy for metastatic NSCLC; Radiation: stereotactic body radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-Free Survival (PFS) assessed according to RECIST 1.1 in subpopulation of patients with oligometastatic NSCLC
Measured: up to 2 years
Secondary outcomes (4)
Safety (AESI, AEs/SAEs)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured: up to 2 years
To assess the treat failure patterns
Treat failure patterns including local failure and distant metastasis
Measured: up to 2 years
Objective response rate(ORR)
ORR was defined as the proportion of participants with partial response (PR) or complete response (CR) to treatment as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Measured: up to 2 years
and OS Overall Survival(OS)
OS was defined as the time from the date of enrollment until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start30 Sep 2020 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255836
- Sponsor's protocol ID
- ESR-19-20392
- Status last verified
- Jan 2020
- First submitted
- 29 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT04255836
- Acronym / sponsor ID
- ESR-19-20392
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 30 Sep 2020 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 5 Feb 2020 (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 is a Phase II, multi-center pilot study assessing the efficacy and safety of durvalumab combined with chemotherapy and stereotactic body radiotherapy (SBRT) in patients with oligo-metastatic non-small cell lung cancer (NSCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durvalumab therapy | Experimental | Drug: Durvalumab, Drug: the first line chemotherapy for metastatic NSCLC, Radiation: stereotactic body radiotherapy (SBRT)Chemo+Durvalumab (PD-L1 monoclonal antibody)1500 mg every 3 weeks [q3w] intravenously [iv] for 4 cycles, then SBRT 50-60 Gy/≤10f + Durvalumab 1500 mg q4w, then Durvalumab 1500 mg q4w for up to 24 months or until progression or other discontinuation criteria are met. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed non-small cell lung cancer
- ≤3 metastatic organs and ≤5 metastatic lesions (supraclavicular and mediastinal lymph nodes are not classified as distant metastasis; other lymph node
- metastasis一group lymph node region will be classified as one metastatic lesion）
- Tissue biopsy prior to treatment
- ECOG performance score 0-1
Key exclusion criteria (4 listed)
- EGFR mutation or ALK positive.
- Evidence on pulmonary interstitial disease or symptoms of active non-infectious pneumonia.
- Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
- Previous treatment with antibody against pd -1, pd - L1, pd - L2, CD137 or CTLA-4 (including ipilimumab or any antibody or drug against T cell co-stimulation or checkpoint pathway).
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 |
|---|---|---|
| DurvalumabAlso: IMFINZIDurvalumab 1500mg q3w combined with chemotherapy for 4 cycles, then 1500mg q4w combined with SBRT, then 1500mg q4w for PD or up to 24 months | Drug | Durvalumab therapy |
| the first line chemotherapy for metastatic NSCLCpaclitaxel+carboplatin or pemetrexed+cisplatin | Drug | Durvalumab therapy |
| stereotactic body radiotherapy (SBRT)SBRT total doses of 50-60Gy/≤10F | Radiation | Durvalumab therapy |
Primary outcome
PFS
Time frame: up to 2 years
Progression-Free Survival (PFS) assessed according to RECIST 1.1 in subpopulation of patients with oligometastatic NSCLC
4 secondary outcomes
Safety (AESI, AEs/SAEs)
Time frame: up to 2 years
To assess the treat failure patterns
Time frame: up to 2 years
Objective response rate(ORR)
Time frame: up to 2 years
and OS Overall Survival(OS)
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab, the first line chemotherapy for metastatic NSCLC and stereotactic body radiotherapy (SBRT) in people with Carcinoma, Non-Small-Cell Lung, run by Zhejiang Cancer Hospital.
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 5 inclusion and 4 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 5 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: up to 2 years). 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 Feb 2020.