Lung CancerPhase 4RELIEFNCT04613284
Rh-Endostatin Combined With CCRT(50 Gy) Followed by Durvalumab Maintenance for the Treatment of Specific Phase III NSCLC
A Phase 4 study testing Recombinant human endostatin (Endostar) and Thoracic irradiation of 50 Gy with 3DCRT or IMRT in people with Lung Cancer, run by Shanghai Chest Hospital.
Trial summary
A Study to Assess the Effects of Durvalumab following Rh-Endostatin combined with reduced-dose CCRT(50 Gy) in Patients with Stage III Unresectable Non-Small Cell Lung Cancer who can not tolerate 60 Gy irradiation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Recombinant human endostatin (Endostar) and Thoracic irradiation of 50 Gy with 3DCRT or IMRT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to Aug 2023
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at 18-75 years.
- Documented evidence of NSCLC (locally advanced, unresectable, Stage III)
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
- Eastern Cooperative Oncology Group performance status score (ECOG PS) of 0 to 1.
- Estimated life expectancy of more than 12 weeks.
Who cannot join
- Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.
- Active or prior autoimmune disease or history of immunodeficiency.
- Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
- Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.
- Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.
- Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
About this study
Official title: Rh-Endostatin Combined With Low-dose CCRT(50 Gy) Followed by Durvalumab Maintenance for the Treatment of Specific Phase III NSCLC Who Can Not Tolerate 60 Gy Irradiation
A Study to Assess the Effects of Durvalumab following Rh-Endostatin combined with reduced-dose CCRT(50 Gy) in Patients with Stage III Unresectable Non-Small Cell Lung Cancer who can not tolerate 60 Gy irradiation.
Read the detailed description
A Phase II, Single-arm, Multi-centre Study of Durvalumab as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Rh-Endostatin combined with reduced-dose CCRT(50 Gy) Therapy (Relief)
- Conditions
- Lung Cancer
- Being tested
- Recombinant human endostatin (Endostar), Thoracic irradiation of 50 Gy with 3DCRT or IMRT
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human endostatin (Endostar)Drug
Also called Durvalumab
Continuous intravenous infusion of endostar (Simcere Pharma- ceutical, Nanjing, China) was made over 120 h before the begin- ning of radiotherapy, and then repeated every two weeks. The dose was 7.5 mg/m2/24 h 120 h, 14 days/cycle. ECG monitoring was performed during the first delivery of endostar.
Thoracic irradiation of 50 Gy with 3DCRT or IMRTRadiation
Concurrent thoracic chemoradiotherapy with reduced irradiation dose of 50 Gy will be given to patients with unresectable stage III NSCLC who can not tolerate irradiation dose to 60 Gy.
| Study group | Role | What they receive |
|---|---|---|
| Endostar combined Radiation | Experimental | Not described Receives: Drug: Recombinant human endostatin (Endostar); Radiation: Thoracic irradiation of 50 Gy with 3DCRT or IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
PFS was defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression).
Measured: up to approximately 3 years
adverse events (AE)
Number of participants with adverse events as assessed by CTCAE v5.0
Measured: 5 years from patient enrollment
Secondary outcomes (2)
Overall Survival
OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using the Kaplan-Meier technique.
Measured: up to 5 years from patient enrollment
Objective Response Rate
ORR was defined as the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.
Measured: Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter up to 3 three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionAug 2023 (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.
- More trials run by Shanghai Chest 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan University
- Responsible party
- Principal investigator, Xuwei Cai, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613284
- Sponsor's protocol ID
- CXW001
- Acronym
- RELIEF
- Status last verified
- Oct 2020
- First submitted
- 18 Aug 2020
- Last updated
- 3 Nov 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 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rh-Endostatin Combined With Low-dose CCRT(50 Gy) Followed by Durvalumab Maintenance for the Treatment of Specific Phase III NSCLC Who Can Not Tolerate 60 Gy Irradiation
- ClinicalTrials.gov ID
- NCT04613284
- Acronym / sponsor ID
- RELIEF / CXW001
- Conditions
- Lung Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Wuhan University
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 3 Nov 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.
A Study to Assess the Effects of Durvalumab following Rh-Endostatin combined with reduced-dose CCRT(50 Gy) in Patients with Stage III Unresectable Non-Small Cell Lung Cancer who can not tolerate 60 Gy irradiation.
Detailed description
A Phase II, Single-arm, Multi-centre Study of Durvalumab as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Rh-Endostatin combined with reduced-dose CCRT(50 Gy) Therapy (Relief)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endostar combined Radiation | Experimental | Drug: Recombinant human endostatin (Endostar), Radiation: Thoracic irradiation of 50 Gy with 3DCRT or IMRT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age at 18-75 years.
- Documented evidence of NSCLC (locally advanced, unresectable, Stage III)
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
- Eastern Cooperative Oncology Group performance status score (ECOG PS) of 0 to 1.
- Estimated life expectancy of more than 12 weeks.
Key exclusion criteria (6 listed)
- Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.
- Active or prior autoimmune disease or history of immunodeficiency.
- Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
- Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.
- Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.
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 |
|---|---|---|
| Recombinant human endostatin (Endostar)Also: DurvalumabContinuous intravenous infusion of endostar (Simcere Pharma- ceutical, Nanjing, China) was made over 120 h before the begin- ning of radiotherapy, and then repeated every two weeks. The dose was 7.5 mg/m2/24 h 120 h, 14 days/cycle. ECG monitoring was performed during the first delivery of endostar. | Drug | Endostar combined Radiation |
| Thoracic irradiation of 50 Gy with 3DCRT or IMRTConcurrent thoracic chemoradiotherapy with reduced irradiation dose of 50 Gy will be given to patients with unresectable stage III NSCLC who can not tolerate irradiation dose to 60 Gy. | Radiation | Endostar combined Radiation |
Primary outcome
Progression Free Survival
Time frame: up to approximately 3 years
PFS was defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression).
adverse events (AE)
Time frame: 5 years from patient enrollment
Number of participants with adverse events as assessed by CTCAE v5.0
2 secondary outcomes
Overall Survival
Time frame: up to 5 years from patient enrollment
Objective Response Rate
Time frame: Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter up to 3 three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 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 4 study testing Recombinant human endostatin (Endostar) and Thoracic irradiation of 50 Gy with 3DCRT or IMRT in people with Lung Cancer, run by Shanghai Chest 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 6 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 Nov 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Progression Free Survival (time frame: up to approximately 3 years). The study lists 2 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 Nov 2020.