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Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin

ConditionLung Cancer, Small Cell
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Chest Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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）;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chemotherapy （Etoposide and Carboplatin）

    Drug

    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

    Envafolimab: 300mg, Q3W, subcutaneous injection is administered on day 1 of each cycle.

  • Trilaciclib

    Drug

    Trilaciclib: 240mg/m2, Q3W, intravenous infusion should be completed within 4 hours before daily chemotherapy

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Trilaciclib+Envafolimab+Chemotherapy Group（TEC Group）Experimental treatment 3 interventions
Group B: Envafolimab+Chemotherapy Group（EC Group）Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

1

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)
2

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)
3

The incidence of febrile neutropenia during chemotherapy

Time frame
From enrollment to the end of Cycle 6 (each cycle is 21 days)
4

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)

Other outcomes

1

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)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Chest Hospital

Lead sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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