Lung NeoplasmsPhase 2NCT05904015
The Study of Envafolimab Combined With Concurrent Chemoradiotherapy In LS-SCLC
A Phase 2 study testing Envafolimab combined with concurrent chemoradiotherapy (Hypofractionated radiotherapy) and Envafolimab combined with concurrent chemoradiotherapy (Conventional Radiotherapy) in people with Lung Neoplasms, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
To evaluate the efficacy and safety of envafolimab combined with concurrent chemoradiotherapy in limited stage small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Envafolimab combined with concurrent chemoradiotherapy (Hypofractionated radiotherapy) and Envafolimab combined with concurrent chemoradiotherapy (Conventional Radiotherapy)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 30 Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The result of histopathological or cytological diagnosis is small cell lung cancer.
- Diagnosed as limited stage by imaging examination (lesion limited to half chest and one radiotherapy field, without malignant pleural or pericardial effusion); And at least one measurable lesion that meets the RECIST 1.1 standard.
- Have not received systematic treatment in the past, and initially underwent 2 cycles of etoposide+cisplatin/carboplatin induction therapy.
- Age 18-75 years old, male or non pregnant female.
- The expected survival period is>3 months.
- ECOG score 0-1.
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- Weight>30 kilograms.
- All patients underwent chest CT, head MRI, abdominal CT or MRI, and whole body bone scan before treatment to clarify.
- Hematological indicators: white blood cell (WBC) count ≥ 4 * 109/L, absolute neutrophil count (ANC) ≥ 1.5 * 109/L, hemoglobin (Hb) level>100 g/L, platelet (Plt) count>100 * 109/L, serum creatinine (Cr) level<1.5 times the upper limit of normal value, serum alanine transaminase (AST) and glutamic transaminase (ALT) levels<2.5 times the upper limit of normal value, and serum bilirubin level ≤ 1.5 times the upper limit of normal value.
- The patient has signed an informed notice and is willing and able to comply with the visit, treatment plan, laboratory examination, and other research procedures of the research plan.
Who cannot join
- Patients with non-small cell lung cancer or mixed components of small cell lung cancer in histopathology.
- Patients with extensive stage small cell lung cancer (ES-SCLC).
- Merge malignant pleural effusion and pericardial effusion.
- Pregnant and lactating women.
- Merge patients with more severe underlying diseases.
- Patients who have previously been treated with inhibitors of immune regulatory points (CTLA-4, PD-1, PD-L1, etc.).
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- Patients may require long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive doses for comorbidities.
- Patients with immunodeficiency disorders and a history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, hyperthyroidism, hypothyroidism; vitiligo or childhood asthma. Patients who have completely relieved and do not require any intervention after adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included).
- Those whose laboratory test values during the screening period before enrollment do not meet relevant standards.
- Patients with significantly reduced heart, liver, lung, kidney, and bone marrow function.
- Serious and uncontrolled internal diseases and infections.
- Simultaneously using other investigational drugs or in other clinical trials.
- Refusal or inability to sign informed consent form for participation in the experiment.
- A history of allergies to etoposide, cisplatin, or any excipients.
- Researchers have determined that patients are not suitable to participate in the study and are unlikely to comply with the study procedures, limitations, and requirements.
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: A Prospective, Two Cohort, Multicenter Phase II Clinical Study of Envafolimab Combined With Concurrent Chemoradiotherapy and Immune Maintenance Therapy For Limited Stage Small Cell Lung Cancer
To evaluate the efficacy and safety of envafolimab combined with concurrent chemoradiotherapy in limited stage small cell lung cancer.
Read the detailed description
Envafolimab is the world's first subcutaneous injection of PD-L1 monoclonal antibody. Suitable for adult patients with advanced solid tumors with unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defects (dMMR).
- Conditions
- Lung Neoplasms
- Being tested
- Envafolimab combined with concurrent chemoradiotherapy (Hypofractionated radiotherapy), Envafolimab combined with concurrent chemoradiotherapy (Conventional Radiotherapy)
- Keywords
- Envafolimab/SCLC/Chemoradiotherapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Envafolimab combined with concurrent chemoradiotherapy (Hypofractionated radiotherapy)Drug
Also called Hypofractionated Radiotherapy Group
Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin: Cisplatin: 75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 45Gy at a 95% PTV dose, with a single split dose of 3Gy, once a day, 5 times a week, for a total of 15 times.
Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable.
Envafolimab combined with concurrent chemoradiotherapy (Conventional Radiotherapy)Drug
Also called Conventional Radiotherapy Group
Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin:Cisplatin:75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 60Gy at a 95% PTV dose, with a single split dose of 2Gy, once per day, 5 times per week, for a total of 30 times.
Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable.
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated radiotherapy group | Experimental | Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin: Cisplatin: 75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 45Gy at a 95% PTV dose, with a single split dose of 3Gy, once a day, 5 times a week, for a total of 15 times.
Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable. Receives: Drug: Envafolimab combined with concurrent chemoradiotherapy (Hypofractionated radiotherapy) |
| Conventional Radiotherapy | Experimental | Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin:Cisplatin:75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 60Gy at a 95% PTV dose, with a single split dose of 2Gy, once per day, 5 times per week, for a total of 30 times Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable. Receives: Drug: Envafolimab combined with concurrent chemoradiotherapy (Conventional Radiotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year PFS rate
2-yaer progression-free survival rate
Measured: From date of randomization until the date of first documented progression or date of death from any cause up to 24 months.
Secondary outcomes (5)
ORR
Objective Response Rate
Measured: From date of randomization until the date of first documented progression or date of death from any cause up to 24 months.
DCR
Disease control rate
Measured: From date of randomization until the date of intolerance the toxicity or PD up to 24 months.
DOR
Duration of response
Measured: From date of randomization until the date of intolerance the toxicity or PD up to 24 months.
OS
Overall survival
Measured: From date of randomization until the date of death(up to 24 months)
Adverse event rate Adverse event rate Adverse event rate
Number of participants with adverse events as a measure of safety and tolerability
Measured: From date of randomization until the date of toxicity or PD (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Aug 2023 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LVHUA WANG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- LvHua Wang, Doc, Study chair, Cancer Hospital Chinese Academy of Medical Sciences,ShenZhen Cencer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904015
- Sponsor's protocol ID
- RT-LC03
- Status last verified
- Jun 2023
- First submitted
- 30 Apr 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Govindan R, Page N, Morgensztern D, Read W, Tierney R, Vlahiotis A, Spitznagel EL, Piccirillo J. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol. 2006 Oct 1;24(28):4539-44. doi: 10.1200/JCO.2005.04.4859.
PubMed 17008692Toh CK, Gao F, Lim WT, Leong SS, Fong KW, Yap SP, Hsu AA, Eng P, Koong HN, Thirugnanam A, Tan EH. Differences between small-cell lung cancer and non-small-cell lung cancer among tobacco smokers. Lung Cancer. 2007 May;56(2):161-6. doi: 10.1016/j.lungcan.2006.12.016. Epub 2007 Jan 31.
PubMed 17270313Sun JM, Choi YL, Ji JH, Ahn JS, Kim KM, Han J, Ahn MJ, Park K. Small-cell lung cancer detection in never-smokers: clinical characteristics and multigene mutation profiling using targeted next-generation sequencing. Ann Oncol. 2015 Jan;26(1):161-166. doi: 10.1093/annonc/mdu504. Epub 2014 Oct 29.
PubMed 25355724Sundstrom S, Bremnes RM, Kaasa S, Aasebo U, Hatlevoll R, Dahle R, Boye N, Wang M, Vigander T, Vilsvik J, Skovlund E, Hannisdal E, Aamdal S; Norwegian Lung Cancer Study Group. Cisplatin and etoposide regimen is superior to cyclophosphamide, epirubicin, and vincristine regimen in small-cell lung cancer: results from a randomized phase III trial with 5 years' follow-up. J Clin Oncol. 2002 Dec 15;20(24):4665-72. doi: 10.1200/JCO.2002.12.111.
PubMed 12488411
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Two Cohort, Multicenter Phase II Clinical Study of Envafolimab Combined With Concurrent Chemoradiotherapy and Immune Maintenance Therapy For Limited Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05904015
- Acronym / sponsor ID
- RT-LC03
- Conditions
- Lung Neoplasms
- Keywords
- Envafolimab/SCLC/Chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Jun 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.
To evaluate the efficacy and safety of envafolimab combined with concurrent chemoradiotherapy in limited stage small cell lung cancer.
Detailed description
Envafolimab is the world's first subcutaneous injection of PD-L1 monoclonal antibody. Suitable for adult patients with advanced solid tumors with unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defects (dMMR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated radiotherapy group | Experimental | Drug: Envafolimab combined with concurrent chemoradiotherapy (Hypofractionated radiotherapy)Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin: Cisplatin: 75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 45Gy at a 95% PTV dose, with a single split dose of 3Gy, once a day, 5 times a week, for a total of 15 times. Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable. |
| Conventional Radiotherapy | Experimental | Drug: Envafolimab combined with concurrent chemoradiotherapy (Conventional Radiotherapy)Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin:Cisplatin:75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 60Gy at a 95% PTV dose, with a single split dose of 2Gy, once per day, 5 times per week, for a total of 30 times Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The result of histopathological or cytological diagnosis is small cell lung cancer.
- Diagnosed as limited stage by imaging examination (lesion limited to half chest and one radiotherapy field, without malignant pleural or pericardial effusion); And at least one measurable lesion that meets the RECIST 1.1 standard.
- Have not received systematic treatment in the past, and initially underwent 2 cycles of etoposide+cisplatin/carboplatin induction therapy.
- Age 18-75 years old, male or non pregnant female.
- The expected survival period is>3 months.
Key exclusion criteria (15 listed)
- Patients with non-small cell lung cancer or mixed components of small cell lung cancer in histopathology.
- Patients with extensive stage small cell lung cancer (ES-SCLC).
- Merge malignant pleural effusion and pericardial effusion.
- Pregnant and lactating women.
- Merge patients with more severe underlying diseases.
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 |
|---|---|---|
| Envafolimab combined with concurrent chemoradiotherapy (Hypofractionated radiotherapy)Also: Hypofractionated Radiotherapy GroupEnvafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin: Cisplatin: 75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 45Gy at a 95% PTV dose, with a single split dose of 3Gy, once a day, 5 times a week, for a total of 15 times. Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable. | Drug | Hypofractionated radiotherapy group |
| Envafolimab combined with concurrent chemoradiotherapy (Conventional Radiotherapy)Also: Conventional Radiotherapy GroupEnvafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin:Cisplatin:75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 60Gy at a 95% PTV dose, with a single split dose of 2Gy, once per day, 5 times per week, for a total of 30 times. Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable. | Drug | Conventional Radiotherapy |
Primary outcome
2-year PFS rate
Time frame: From date of randomization until the date of first documented progression or date of death from any cause up to 24 months.
2-yaer progression-free survival rate
5 secondary outcomes
ORR
Time frame: From date of randomization until the date of first documented progression or date of death from any cause up to 24 months.
DCR
Time frame: From date of randomization until the date of intolerance the toxicity or PD up to 24 months.
DOR
Time frame: From date of randomization until the date of intolerance the toxicity or PD up to 24 months.
OS
Time frame: From date of randomization until the date of death(up to 24 months)
Adverse event rate Adverse event rate Adverse event rate
Time frame: From date of randomization until the date of toxicity or PD (up to 24 months)
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 15 Jun 2023.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 17008692Govindan R, Page N, Morgensztern D, Read W, Tierney R, Vlahiotis A, Spitznagel EL, Piccirillo J. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol. 2006 Oct 1;24(28):4539-44. doi: 10.1200/JCO.2005.04.4859.
- Background: PubMed 17270313Toh CK, Gao F, Lim WT, Leong SS, Fong KW, Yap SP, Hsu AA, Eng P, Koong HN, Thirugnanam A, Tan EH. Differences between small-cell lung cancer and non-small-cell lung cancer among tobacco smokers. Lung Cancer. 2007 May;56(2):161-6. doi: 10.1016/j.lungcan.2006.12.016. Epub 2007 Jan 31.
- Background: PubMed 25355724Sun JM, Choi YL, Ji JH, Ahn JS, Kim KM, Han J, Ahn MJ, Park K. Small-cell lung cancer detection in never-smokers: clinical characteristics and multigene mutation profiling using targeted next-generation sequencing. Ann Oncol. 2015 Jan;26(1):161-166. doi: 10.1093/annonc/mdu504. Epub 2014 Oct 29.
- Background: PubMed 12488411Sundstrom S, Bremnes RM, Kaasa S, Aasebo U, Hatlevoll R, Dahle R, Boye N, Wang M, Vigander T, Vilsvik J, Skovlund E, Hannisdal E, Aamdal S; Norwegian Lung Cancer Study Group. Cisplatin and etoposide regimen is superior to cyclophosphamide, epirubicin, and vincristine regimen in small-cell lung cancer: results from a randomized phase III trial with 5 years' follow-up. J Clin Oncol. 2002 Dec 15;20(24):4665-72. doi: 10.1200/JCO.2002.12.111.
- 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.
LvHua Wang, Doc study chair
Cancer Hospital Chinese Academy of Medical Sciences,ShenZhen Cencer
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Envafolimab combined with concurrent chemoradiotherapy (Hypofractionated radiotherapy) and Envafolimab combined with concurrent chemoradiotherapy (Conventional Radiotherapy) in people with Lung Neoplasms, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
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 15 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 15 Jun 2023. 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 LvHua Wang, Doc (0755-66618168, wlhwq@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year PFS rate (time frame: From date of randomization until the date of first documented progression or date of death from any cause up to 24 months.). 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 NCT05904015, 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 15 Jun 2023.