Lung Cancer, Small CellPhase 2NCT06698965
Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin
A Phase 2 study testing Chemotherapy （Etoposide and Carboplatin）, Immunotherapy （Envafolimab） and Trilaciclib in people with Lung Cancer, Small Cell, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
This prospective, randomized, controlled phase II study aims to evaluate the efficacy of combination therapy with Envafolimab and chemotherapy in first-line extensive stage SCLC, as well as the impact of Trilaciclib on the incidence of myelosuppression and anti-tumor effects in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Small Cell
- What is being tested?
- Chemotherapy （Etoposide and Carboplatin）, Immunotherapy （Envafolimab） and Trilaciclib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2024to 31 Oct 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, regardless of gender;
- Small cell lung cancer (SCLC) confirmed by histology or cytology;
- Extensive-stage small cell lung cancer, classified as stage IV (any T, any N, M1a/b/c) according to the 8th edition of the AJCC, or T3-4 due to multiple pulmonary nodules or tumor/nodule volume too large to be included in a tolerable radiotherapy plan;
- At least one measurable lesion on imaging（RECIST 1.1）;
- Have not received any systemic anti-tumor treatment for extensive-stage diseases in the past. For patients who have received adjuvant/neoadjuvant chemotherapy in the past, or have received curative radiotherapy and chemotherapy for advanced diseases, if there is a gap of at least 6 months between disease progression or recurrence and the end of the last chemotherapy drug treatment, they are eligible to be included in this study;
- Patients with asymptomatic brain metastases or brain metastases whose symptoms have stabilized after treatment;
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- Subjects are allowed to receive palliative radiation therapy (including cranial radiation therapy for symptomatic brain metastases), but the radiation therapy must be completed at least one week before enrollment;
- The laboratory test results meet the following criteria: Hemoglobin ≥ 90 g/L, neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L; Creatinine clearance rate (CrCl) ≥ 60 mL/min (as calculated using the Cockcroft-Gault formula); Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN or ≤ 5 × ULN (for patients with liver metastases); albumin ≥ 30 g/L; International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; Thyroid stimulating hormone (TSH) is within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; The myocardial enzyme profile is within the normal range (simple laboratory abnormalities that are deemed clinically insignificant by the researchers are also allowed to be included).;
- ECOG PS score 0 or 1;
- Expected survival time ≥ 3 months;
- For Female Participants: All Female Participants with potential fertility must have a negative serum pregnancy test result during the screening period, and must take reliable contraceptive measures from signing the informed consent form until 3 months after the last dose;
- Understand and sign the informed consent form.
Who cannot join
- Diagnosed with malignant diseases other than SCLC within 5 years prior to the first administration (excluding curative basal cell carcinoma, squamous cell carcinoma, and/or excised carcinoma in situ);
- Mixed SCLC and NSCLC confirmed by histology or cytology;
- Currently participating in interventional clinical research treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first administration;
- Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors (such as CTLA-4, OX-40, CD137);
- Within 2 weeks before the first administration, the individual has received systematic systemic treatment with traditional Chinese patent medicines and simple preparations with anti lung cancer indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion and pleural effusion);
- Within 2 years prior to the first administration, the individual has been an active autoimmune disease requiring systemic treatment (such as the use of disease relieving drugs, corticosteroids, or immunosuppressants). Alternative therapies (such as thyroid hormone, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) are not considered systemic treatments;
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- Within 7 days prior to the first administration of the study, the individual was receiving systemic corticosteroid therapy (excluding topical corticosteroids via nasal spray, inhalation, or other routes) or any other form of immunosuppressive therapy; Note: Physiological doses of glucocorticoids (≤ 10 mg/day of prednisone or equivalent) are allowed to be used;
- Individuals who are known to be allergic to the active ingredients or excipients of the investigational drugs, such as trilaciclib, envafolimab, etoposide, carboplatin, etc;
- Patients with clinically uncontrollable pleural/peritoneal effusion (those who do not require drainage or have no significant increase in effusion after stopping drainage for 3 days can be enrolled);
- Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive) or untreated active HBV, HCV;
- Pregnant or lactating female participants;
- Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Hua Zhong, MD, 18017321320, eddiedong8@hotmail.com
About this study
Official title: A Randomized, Controlled Phase II Clinical Study on the Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin
This prospective, randomized, controlled phase II study aims to evaluate the efficacy of combination therapy with Envafolimab and chemotherapy in first-line extensive stage SCLC, as well as the impact of Trilaciclib on the incidence of myelosuppression and anti-tumor effects in patients.
- Conditions
- Lung Cancer, Small Cell
- Being tested
- Chemotherapy （Etoposide and Carboplatin）, Immunotherapy （Envafolimab）, Trilaciclib
- Keywords
- SCLC, first-line treatment, immunotherapy, myelosuppression
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy （Etoposide and Carboplatin）Drug
Also called Etoposide+Carboplatin
Etoposide: 80-100mg/m2, Q3W, intravenous infusion is administered on day 1, 2 and 3 of each cycle.
Carboplatin: AUC=5, Q3W, intravenous infusion is administered on day 1 of each cycle.
Immunotherapy （Envafolimab）Drug
Also called Envafolimab
Envafolimab: 300mg, Q3W, subcutaneous injection is administered on day 1 of each cycle.
TrilaciclibDrug
Trilaciclib: 240mg/m2, Q3W, intravenous infusion should be completed within 4 hours before daily chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Trilaciclib+Envafolimab+Chemotherapy Group（TEC Group） | Experimental | TEC Group received received treatment with Envafolimab in combination with Etoposide and Carboplatin for 6 cycles. Prior to each chemotherapy cycle, they were given Trilaciclib before each chemotherapy session. After 6 cycles, they were treated with Trilaciclib in combination with Envafolimab as maintenance therapy until disease progression, intolerable adverse reactions, or withdrawal of informed consent by the patient occurred, with a maximum duration not exceeding 2 years. Receives: Drug: Chemotherapy （Etoposide and Carboplatin）; Drug: Immunotherapy （Envafolimab）; Drug: Trilaciclib |
| Envafolimab+Chemotherapy Group（EC Group） | Active comparator | EC Group received received treatment with Envafolimab in combination with Etoposide and Carboplatin for 6 cycles. After 6 cycles, they were treated with Envafolimab as maintenance therapy until disease progression, intolerable adverse reactions, or withdrawal of informed consent by the patient occurred, with a maximum duration not exceeding 2 years. Receives: Drug: Chemotherapy （Etoposide and Carboplatin）; Drug: Immunotherapy （Envafolimab） |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of grade ≥ 3 neutropenia during chemotherapy treatment
According to CTCAE5.0
Measured: From enrollment to the end of Cycle 6 (each cycle is 21 days)
Secondary outcomes (16)
The incidence of ≥ grade 3 thrombocytopenia or anemia during chemotherapy
Measured: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The duration of severe neutropenia in the first treatment cycle
Measured: From enrollment to the end of Cycle 1 (each cycle is 21 days)
The incidence of febrile neutropenia during chemotherapy
Measured: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The usage rate of granulocyte colony-stimulating factor (PEG-G-CSF/G-CSF) during chemotherapy
Measured: From enrollment to the end of Cycle 6 (each cycle is 21 days)
Disease burden of patients during chemotherapy
Based on EQ-5D-5L scales scores（The score range is from 5 to 25 points, with higher scores indicating better outcomes）
Measured: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The usage rate of erythropoietin (ESA) during chemotherapy
Measured: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The usage rate of recombinant human interleukin-11 during chemotherapy
Measured: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The usage rate of thrombopoietin (TPO) during chemotherapy
Measured: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The usage rate of iron supplement during chemotherapy
Measured: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The incidence of platelet transfusion during chemotherapy
Measured: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The incidence of red blood cell transfusion during chemotherapy
Measured: From enrollment to the end of Cycle 6 (each cycle is 21 days)
ORR
Objective response rate
Measured: From enrollment to the end of Cycle 6 (each cycle is 21 days)
DCR
disease control rate
Measured: From enrollment to the end of Cycle 6 (each cycle is 21 days)
DOR
Duration of response
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
PFS
Progression-Free-Survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
OS
Overall survival
Measured: From date of randomization until the date of death from any cause, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start13 Oct 2024
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Small CellStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Hua Zhong, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698965
- Sponsor's protocol ID
- IS24047
- Status last verified
- Nov 2024
- First submitted
- 18 Oct 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Phase II Clinical Study on the Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin
- ClinicalTrials.gov ID
- NCT06698965
- Acronym / sponsor ID
- IS24047
- Conditions
- Lung Cancer, Small Cell
- Keywords
- SCLC, first-line treatment, immunotherapy, myelosuppression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Study start
- 13 Oct 2024 (actual)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 21 Nov 2024 (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 prospective, randomized, controlled phase II study aims to evaluate the efficacy of combination therapy with Envafolimab and chemotherapy in first-line extensive stage SCLC, as well as the impact of Trilaciclib on the incidence of myelosuppression and anti-tumor effects in patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trilaciclib+Envafolimab+Chemotherapy Group（TEC Group） | Experimental | Drug: Chemotherapy （Etoposide and Carboplatin）, Drug: Immunotherapy （Envafolimab）, Drug: TrilaciclibTEC Group received received treatment with Envafolimab in combination with Etoposide and Carboplatin for 6 cycles. Prior to each chemotherapy cycle, they were given Trilaciclib before each chemotherapy session. After 6 cycles, they were treated with Trilaciclib in combination with Envafolimab as maintenance therapy until disease progression, intolerable adverse reactions, or withdrawal of informed consent by the patient occurred, with a maximum duration not exceeding 2 years. |
| Envafolimab+Chemotherapy Group（EC Group） | Active comparator | Drug: Chemotherapy （Etoposide and Carboplatin）, Drug: Immunotherapy （Envafolimab）EC Group received received treatment with Envafolimab in combination with Etoposide and Carboplatin for 6 cycles. After 6 cycles, they were treated with Envafolimab as maintenance therapy until disease progression, intolerable adverse reactions, or withdrawal of informed consent by the patient occurred, with a maximum duration not exceeding 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years, regardless of gender;
- Small cell lung cancer (SCLC) confirmed by histology or cytology;
- Extensive-stage small cell lung cancer, classified as stage IV (any T, any N, M1a/b/c) according to the 8th edition of the AJCC, or T3-4 due to multiple pulmonary nodules or tumor/nodule volume too large to be included in a tolerable radiotherapy plan;
- At least one measurable lesion on imaging（RECIST 1.1）;
- Have not received any systemic anti-tumor treatment for extensive-stage diseases in the past. For patients who have received adjuvant/neoadjuvant chemotherapy in the past, or have received curative radiotherapy and chemotherapy for advanced diseases, if there is a gap of at least 6 months between disease progression or recurrence and the end of the last chemotherapy drug treatment, they are eligible to be included in this study;
Key exclusion criteria (12 listed)
- Diagnosed with malignant diseases other than SCLC within 5 years prior to the first administration (excluding curative basal cell carcinoma, squamous cell carcinoma, and/or excised carcinoma in situ);
- Mixed SCLC and NSCLC confirmed by histology or cytology;
- Currently participating in interventional clinical research treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first administration;
- Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors (such as CTLA-4, OX-40, CD137);
- Within 2 weeks before the first administration, the individual has received systematic systemic treatment with traditional Chinese patent medicines and simple preparations with anti lung cancer indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion and pleural effusion);
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 |
|---|---|---|
| Chemotherapy （Etoposide and Carboplatin）Also: Etoposide+CarboplatinEtoposide: 80-100mg/m2, Q3W, intravenous infusion is administered on day 1, 2 and 3 of each cycle. Carboplatin: AUC=5, Q3W, intravenous infusion is administered on day 1 of each cycle. | Drug | Envafolimab+Chemotherapy Group（EC Group）, Trilaciclib+Envafolimab+Chemotherapy Group（TEC Group） |
| Immunotherapy （Envafolimab）Also: EnvafolimabEnvafolimab: 300mg, Q3W, subcutaneous injection is administered on day 1 of each cycle. | Drug | Envafolimab+Chemotherapy Group（EC Group）, Trilaciclib+Envafolimab+Chemotherapy Group（TEC Group） |
| TrilaciclibTrilaciclib: 240mg/m2, Q3W, intravenous infusion should be completed within 4 hours before daily chemotherapy | Drug | Trilaciclib+Envafolimab+Chemotherapy Group（TEC Group） |
Primary outcome
The incidence of grade ≥ 3 neutropenia during chemotherapy treatment
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
According to CTCAE5.0
16 secondary outcomes
The incidence of ≥ grade 3 thrombocytopenia or anemia during chemotherapy
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The duration of severe neutropenia in the first treatment cycle
Time frame: From enrollment to the end of Cycle 1 (each cycle is 21 days)
The incidence of febrile neutropenia during chemotherapy
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The usage rate of granulocyte colony-stimulating factor (PEG-G-CSF/G-CSF) during chemotherapy
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
Disease burden of patients during chemotherapy
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The usage rate of erythropoietin (ESA) during chemotherapy
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The usage rate of recombinant human interleukin-11 during chemotherapy
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The usage rate of thrombopoietin (TPO) during chemotherapy
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The usage rate of iron supplement during chemotherapy
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The incidence of platelet transfusion during chemotherapy
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The incidence of red blood cell transfusion during chemotherapy
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
ORR
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
DCR
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
DOR
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
OS
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 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 21 Nov 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemotherapy （Etoposide and Carboplatin）, Immunotherapy （Envafolimab） and Trilaciclib in people with Lung Cancer, Small Cell, run by Shanghai Chest Hospital 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 12 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 21 Nov 2024. 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 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 Hua Zhong, MD (18017321320, eddiedong8@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of grade ≥ 3 neutropenia during chemotherapy treatment (time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)). 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 21 Nov 2024.