RecruitingNCT06698965Updated Nov 21, 2024

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 interventional study of Chemotherapy （Etoposide and Carboplatin） and Immunotherapy （Envafolimab） in Lung Cancer, Small Cell, sponsored by Shanghai Chest Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-21.

Sponsored by Shanghai Chest Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

Started Oct 2024; still recruiting 1 year 11 months later.

Phase: Phase 2
Study type: Interventional
Enrollment: 52
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Lung Cancer, Small Cell

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Keywords

SCLC
first-line treatment
immunotherapy
myelosuppression

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 52 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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;
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.

Exclusion criteria

Exclusion Criteria:

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;
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)

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 52 participants (estimated)

Study arms

Experimental
Trilaciclib+Envafolimab+Chemotherapy Group（TEC Group）
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.
Drug: Chemotherapy （Etoposide and Carboplatin） · Drug: Immunotherapy （Envafolimab） · Drug: Trilaciclib
Active comparator
Envafolimab+Chemotherapy Group（EC Group）
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.
Drug: Chemotherapy （Etoposide and Carboplatin） · Drug: Immunotherapy （Envafolimab）

Interventions

DrugChemotherapy （Etoposide and 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.
Also known as: Etoposide+Carboplatin
DrugImmunotherapy （Envafolimab）
Envafolimab: 300mg, Q3W, subcutaneous injection is administered on day 1 of each cycle.
Also known as: Envafolimab
DrugTrilaciclib
Trilaciclib: 240mg/m2, Q3W, intravenous infusion should be completed within 4 hours before daily chemotherapy

What researchers measure

Primary outcomes

The incidence of grade ≥ 3 neutropenia during chemotherapy treatment
According to CTCAE5.0
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)

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
Based on EQ-5D-5L scales scores（The score range is from 5 to 25 points, with higher scores indicating better outcomes）
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
Objective response rate
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
DCR
disease control rate
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
DOR
Duration of response
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
Progression-Free-Survival
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
Overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months

Other outcomes

Dynamic changes of immune cell subsets and cytokines in peripheral blood before and after treatment
Including but not limited to the ratio of CD8+T/Treg and the number of T cell clones
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)

Study locations

1 of 1 sites recruiting

Shanghai Chest Hospital
Shanghai, Shanghai 200030, China
- Hua Zhong, MD · Contact · eddiedong8@hotmail.com · 18017321320
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06698965
Lead sponsor: Shanghai Chest Hospital
Collaborators: Jiangsu Simcere Pharmaceutical Co., Ltd.
Responsible party: Hua Zhong (Zhong Dr., MD, Shanghai Chest Hospital) — Principal investigator
First posted: Nov 21, 2024
Start date: Oct 13, 2024
Primary completion: Oct 31, 2029 (estimated)
Completion: Oct 31, 2029 (estimated)
Last update: Nov 21, 2024

Study contacts

Hua Zhong, MD

Contact

eddiedong8@hotmail.com

18017321320

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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