Lung CancerPhase 2NCT05484583
Durvalumab Combined With Consolidation Radiotherapy After First-line Treatment in Extensive Stage Small Cell Lung Cancer With Oligometastases
A Phase 2 study testing Durvalumab + carboplatin/cisplatin + etoposide, Consolidation radiotherapy and Durvalumab in people with Lung Cancer and Extensive-stage Small-cell Lung Cancer, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University.
Trial summary
In patients with oligometastatic (1-5 lesions) extensive-stage small cell lung cancer, to explore the efficacy and safety of Durvalumab immunotherapy combined with chemotherapy followed by consolidation radiotherapy, to provide scientific basis for the formulation of the best comprehensive treatment plan in the future. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Cancer, Extensive-stage Small-cell Lung Cancer, Radiotherapy
- What is being tested?
- Durvalumab + carboplatin/cisplatin + etoposide, Consolidation radiotherapy and Durvalumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 Aug 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Within 4 weeks before enrollment or within 5 half-lives of the drug (whichever is the longer), systemic immune stimulants (including but not limited to interferon, interleukin-2, tumor necrosis factor) are used (cancer vaccines are allowed in previous treatments)
- Within 14 days before the first administration of the drug, any Chinese herbal medicine used to control cancer was used.
- Any disease that must be treated with corticosteroids (prednisone > 10mg/ days or equivalent) or other immunosuppressive drugs within 14 days before enrollment Note: patients who have used or have used any of the following steroid regimens can be selected: epinephrine replacement steroids (prednisone ≤ 10mg/ days or equivalent). Inhaled corticosteroids with very low local, ocular, articular, nasal or systemic absorption; prophylactic use of prescription corticosteroids in a short course (≤ 7 days) or for the treatment of non-autoimmune diseases (such as delayed anaphylaxis caused by contact allergens)
- Live vaccine is given within 4 weeks before joining the group. Note: seasonal influenza vaccine is usually an inactivated vaccine, and patients who receive such vaccine are allowed to join the group. The intranasal influenza vaccine is a live vaccine, and patients vaccinated with such vaccine are not allowed to enter the group.
- Any major surgery requiring general anesthesia was performed within 28 days before enrollment.
- Previous allogeneic stem cell transplantation or organ transplantation
Show all 17Show fewer
- Clinically uncontrolled pericardial effusion or ascites requiring pleural or abdominal puncture drainage within 2 weeks before randomization. Uncontrolled brain metastasis with active leptomeningeal disease:
- patients with asymptomatic central nervous system (CNS) metastasis during the screening phase can be selected if all of the following conditions are met: brain imaging examinations during the screening phase show that there is no evidence of mid-term progression between completion of immunotherapy combined with chemotherapy induction therapy and enrollment; no continuous use of corticosteroids for CNS disease; and permitting stable doses of anticonvulsant therapy.
- Suffer from active autoimmune diseases or have a history of autoimmune diseases that may recur. Note: patients with the following diseases can be further screened: well-controlled type 1 diabetic hypothyroidism (only thyroid hormone replacement therapy can be controlled); well-controlled celiac disease; any other diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia) that are not expected to recur without external triggers
- Has suffered from interstitial lung disease or non-communicable pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.
- Severe chronic or active infections that require systemic antibacterial, antifungal or antiviral therapy within 2 weeks before enrollment, including, but not limited to, tuberculosis
- Any active malignant tumor less than 2 years before enrollment, except for specific cancers examined in this study and any locally recurrent cancers that have been cured (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ)
- Untreated chronic hepatitis B patients, chronic hepatitis B virus carriers with HBV DNA ≥ 500 IU / mL (2500 copies / mL), active hepatitis C patients: patients with inactive HBsAg carriers and patients with stable active HBV infection (HBVDNA < 500 IU/mL (2500 copies / mL)) after drug treatment can be enrolled. Only patients with positive hepatitis B core antigen (anti-hepatitis B core antigen antibody) were tested for HBVDNA. Patients who were negative for hepatitis C virus (HCV) antibody during screening, or those who were positive for HCV antibody and then negative for HCV RNA test during screening could be included in the study. Only hepatitis C virus (HCV) antibody positive patients will be tested for HCVRNA. Note: patients who can detect hepatitis B surface antigen (HBsAg) or HBVDNA should be treated in accordance with treatment guidelines. Patients who received antiviral therapy at the time of screening should have been treated for more than 2 weeks before joining the group and continued treatment for 6 months after discontinuing the study drug treatment.
- he known history of HIV infection 16. is 16. 5%. There are any of the following cardiovascular risk factors: a. Cardiogenic chest pain occurred ≤ 28 days before randomization, which was defined as moderate pain limiting instrumental activities of daily life b. Symptomatic pulmonary embolism occurred ≤ 28 days before randomization. There was any history of acute myocardial infarction less than 6 months before randomization. There was a history of heart failure in New York Heart Association (NYHA) grade III or IV (Appendix 5) ≤ 6 months before randomization. Ventricular arrhythmias with severity ≥ 2 occurred less than 6 months before randomization. There was a history of cerebrovascular accident less than 6 months before randomization. Uncontrolled hypertension: ≤ 28 days before randomization, despite the use of antihypertensive drugs, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg. Syncope or seizures occurred less than 28 days before randomization.
- Patients with side effects (due to previous anticancer therapy) did not return to baseline or stable levels at the time of admission, except for adverse event (such as hair loss, neuropathy and specific laboratory abnormalities) that could not pose safety risks.
- Has a history of severe hypersensitivity to other monoclonal antibodies. 19.Suffering from underlying diseases (including abnormal laboratory tests) or alcohol or drug abuse or dependence, which are not conducive to the study of drug administration or affect the interpretation of drug toxicity or adverse event, or may lead to insufficient or reduced compliance with research behavior.
- At the same time, he participated in another therapeutic clinical study.
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: Prospective Phase ii Clinical Study of the Efficacy and Safety of Durvalumab Combined With Consolidation Radiotherapy After First-line Treatment With Platinum-containing Chemotherapy in Extensive Stage Small Cell Lung Cancer With Oligometastases (1-5 Lesions)
In patients with oligometastatic (1-5 lesions) extensive-stage small cell lung cancer, to explore the efficacy and safety of Durvalumab immunotherapy combined with chemotherapy followed by consolidation radiotherapy, to provide scientific basis for the formulation of the best comprehensive treatment plan in the future.
Read the detailed description
To explore the efficacy and safety of consolidation radiotherapy after Durvalumab immunotherapy combined with chemotherapy in patients with oligometastatic small cell lung cancer (1-5 lesions), so as to provide scientific basis for making the best comprehensive treatment plan in the future.All subjects will receive the following treatments:
- Induction period (3 weeks as a cycle, 4 cycles of administration): Durvalumab + carboplatin/cisplatin + etoposide, intravenous drip
- Consolidation radiotherapy period: radiotherapy for primary chest lesions + oligometastatic lesions.
- Maintenance phase (administered every 4 weeks): Durvalumab intravenous infusion.
- Being tested
- Durvalumab + carboplatin/cisplatin + etoposide, Consolidation radiotherapy, Durvalumab
- Medical subject headings
- Lung Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durvalumab + carboplatin/cisplatin + etoposideDrug
Induction period (3 weeks as a cycle, 4 cycles of administration): Durvalumab + carboplatin/cisplatin + etoposide, intravenous drip
Consolidation radiotherapyRadiation
Consolidation radiotherapy period: radiotherapy for primary chest lesions + oligometastatic lesions.
DurvalumabDrug
Maintenance phase (administered every 4 weeks): Durvalumab intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy combined with Durvalumab, etoposide, and cisplatin/carboplatin | Experimental | Radiotherapy combined with Durvalumab, etoposide, and cisplatin/carboplatin Receives: Drug: Durvalumab + carboplatin/cisplatin + etoposide; Radiation: Consolidation radiotherapy; Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival time
Time from the date of first dosing of Durvalumab to death from any cause.
Measured: up to 2 years
Secondary outcomes (2)
locoregional recurrence-free survival
The time from the date of first dosing of Durvalumab to the first appearance of objective disease progression or death from any cause (if it occurs before disease progression).
Measured: up to 2 years
distant metastasis-free survival
The time from the date of first dosing of Durvalumab to the first appearance of the tumor had metastasized.
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 posted2 Aug 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484583
- Sponsor's protocol ID
- ITT-2022-007CFL47
- Status last verified
- Jul 2022
- First submitted
- 1 Aug 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olson R, Mathews L, Liu M, Schellenberg D, Mou B, Berrang T, Harrow S, Correa RJM, Bhat V, Pai H, Mohamed I, Miller S, Schneiders F, Laba J, Wilke D, Senthi S, Louie AV, Swaminath A, Chalmers A, Gaede S, Warner A, de Gruijl TD, Allan A, Palma DA. Stereotactic ablative radiotherapy for the comprehensive treatment of 1-3 Oligometastatic tumors (SABR-COMET-3): study protocol for a randomized phase III trial. BMC Cancer. 2020 May 5;20(1):380. doi: 10.1186/s12885-020-06876-4.
PubMed 32370765Mielgo-Rubio X, Garde-Noguera J, Juan O, Counago F. Stereotactic body radiation therapy: A good dance partner of oligometastatic non-small cell lung cancer to the sound of SINDAS study. World J Clin Oncol. 2020 Dec 24;11(12):983-989. doi: 10.5306/wjco.v11.i12.983.
PubMed 33437660Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Griffioen G, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Bauman GS, Warner A, Senan S. Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial. Lancet. 2019 May 18;393(10185):2051-2058. doi: 10.1016/S0140-6736(18)32487-5. Epub 2019 Apr 11.
PubMed 30982687Yee D, Butts C, Reiman A, Joy A, Smylie M, Fenton D, Chu Q, Hanson J, Roa W. Clinical trial of post-chemotherapy consolidation thoracic radiotherapy for extensive-stage small cell lung cancer. Radiother Oncol. 2012 Feb;102(2):234-8. doi: 10.1016/j.radonc.2011.08.042. Epub 2011 Sep 17.
PubMed 21930323Paz-Ares L, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Ozguroglu M, Ji JH, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Kazarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Shire N, Jiang H, Goldman JW; CASPIAN investigators. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet. 2019 Nov 23;394(10212):1929-1939. doi: 10.1016/S0140-6736(19)32222-6. Epub 2019 Oct 4.
PubMed 31590988
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase ii Clinical Study of the Efficacy and Safety of Durvalumab Combined With Consolidation Radiotherapy After First-line Treatment With Platinum-containing Chemotherapy in Extensive Stage Small Cell Lung Cancer With Oligometastases (1-5 Lesions)
- ClinicalTrials.gov ID
- NCT05484583
- Acronym / sponsor ID
- ITT-2022-007CFL47
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 2 Aug 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.
In patients with oligometastatic (1-5 lesions) extensive-stage small cell lung cancer, to explore the efficacy and safety of Durvalumab immunotherapy combined with chemotherapy followed by consolidation radiotherapy, to provide scientific basis for the formulation of the best comprehensive treatment plan in the future.
Detailed description
To explore the efficacy and safety of consolidation radiotherapy after Durvalumab immunotherapy combined with chemotherapy in patients with oligometastatic small cell lung cancer (1-5 lesions), so as to provide scientific basis for making the best comprehensive treatment plan in the future.All subjects will receive the following treatments:
- Induction period (3 weeks as a cycle, 4 cycles of administration): Durvalumab + carboplatin/cisplatin + etoposide, intravenous drip
- Consolidation radiotherapy period: radiotherapy for primary chest lesions + oligometastatic lesions.
- Maintenance phase (administered every 4 weeks): Durvalumab intravenous infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy combined with Durvalumab, etoposide, and cisplatin/carboplatin | Experimental | Drug: Durvalumab + carboplatin/cisplatin + etoposide, Radiation: Consolidation radiotherapy, Drug: DurvalumabRadiotherapy combined with Durvalumab, etoposide, and cisplatin/carboplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- Within 4 weeks before enrollment or within 5 half-lives of the drug (whichever is the longer), systemic immune stimulants (including but not limited to interferon, interleukin-2, tumor necrosis factor) are used (cancer vaccines are allowed in previous treatments)
- Within 14 days before the first administration of the drug, any Chinese herbal medicine used to control cancer was used.
- Any disease that must be treated with corticosteroids (prednisone > 10mg/ days or equivalent) or other immunosuppressive drugs within 14 days before enrollment Note: patients who have used or have used any of the following steroid regimens can be selected: epinephrine replacement steroids (prednisone ≤ 10mg/ days or equivalent). Inhaled corticosteroids with very low local, ocular, articular, nasal or systemic absorption; prophylactic use of prescription corticosteroids in a short course (≤ 7 days) or for the treatment of non-autoimmune diseases (such as delayed anaphylaxis caused by contact allergens)
- Live vaccine is given within 4 weeks before joining the group. Note: seasonal influenza vaccine is usually an inactivated vaccine, and patients who receive such vaccine are allowed to join the group. The intranasal influenza vaccine is a live vaccine, and patients vaccinated with such vaccine are not allowed to enter the group.
- Any major surgery requiring general anesthesia was performed within 28 days before enrollment.
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 |
|---|---|---|
| Durvalumab + carboplatin/cisplatin + etoposideInduction period (3 weeks as a cycle, 4 cycles of administration): Durvalumab + carboplatin/cisplatin + etoposide, intravenous drip | Drug | Radiotherapy combined with Durvalumab, etoposide, and cisplatin/carboplatin |
| Consolidation radiotherapyConsolidation radiotherapy period: radiotherapy for primary chest lesions + oligometastatic lesions. | Radiation | Radiotherapy combined with Durvalumab, etoposide, and cisplatin/carboplatin |
| DurvalumabMaintenance phase (administered every 4 weeks): Durvalumab intravenous infusion | Drug | Radiotherapy combined with Durvalumab, etoposide, and cisplatin/carboplatin |
Primary outcome
overall survival time
Time frame: up to 2 years
Time from the date of first dosing of Durvalumab to death from any cause.
2 secondary outcomes
locoregional recurrence-free survival
Time frame: up to 2 years
distant metastasis-free survival
Time frame: up to 2 years
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 Aug 2022.
- Background: PubMed 32370765Olson R, Mathews L, Liu M, Schellenberg D, Mou B, Berrang T, Harrow S, Correa RJM, Bhat V, Pai H, Mohamed I, Miller S, Schneiders F, Laba J, Wilke D, Senthi S, Louie AV, Swaminath A, Chalmers A, Gaede S, Warner A, de Gruijl TD, Allan A, Palma DA. Stereotactic ablative radiotherapy for the comprehensive treatment of 1-3 Oligometastatic tumors (SABR-COMET-3): study protocol for a randomized phase III trial. BMC Cancer. 2020 May 5;20(1):380. doi: 10.1186/s12885-020-06876-4.
- Background: PubMed 33437660Mielgo-Rubio X, Garde-Noguera J, Juan O, Counago F. Stereotactic body radiation therapy: A good dance partner of oligometastatic non-small cell lung cancer to the sound of SINDAS study. World J Clin Oncol. 2020 Dec 24;11(12):983-989. doi: 10.5306/wjco.v11.i12.983.
- Background: PubMed 30982687Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Griffioen G, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Bauman GS, Warner A, Senan S. Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial. Lancet. 2019 May 18;393(10185):2051-2058. doi: 10.1016/S0140-6736(18)32487-5. Epub 2019 Apr 11.
- Background: PubMed 21930323Yee D, Butts C, Reiman A, Joy A, Smylie M, Fenton D, Chu Q, Hanson J, Roa W. Clinical trial of post-chemotherapy consolidation thoracic radiotherapy for extensive-stage small cell lung cancer. Radiother Oncol. 2012 Feb;102(2):234-8. doi: 10.1016/j.radonc.2011.08.042. Epub 2011 Sep 17.
- Background: PubMed 31590988Paz-Ares L, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Ozguroglu M, Ji JH, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Kazarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Shire N, Jiang H, Goldman JW; CASPIAN investigators. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet. 2019 Nov 23;394(10212):1929-1939. doi: 10.1016/S0140-6736(19)32222-6. Epub 2019 Oct 4.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab + carboplatin/cisplatin + etoposide, Consolidation radiotherapy and Durvalumab in people with Lung Cancer and Extensive-stage Small-cell Lung Cancer, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University.
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 0 inclusion and 17 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 Aug 2022. 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 liao zhiwei (13622876524, vigo310@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival time (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?
On the ClinicalTrials.gov record for NCT05484583, which also lists 5 linked publications.
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 Aug 2022.