Clinical trial NCT05910034: Envafolimab Plus Docetaxel In Combination With or Without Trilaciclib Versus Docetaxel in Advanced NSCLC
Official title: The Study of Envafolimab Plus Docetaxel in Combination With or Without Trilaciclib Versus Docetaxel in Advanced NSCLC Previously Treated With a PD-1 Inhibitor Combined With Chemotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Advanced Non-Small Cell Lung Cancer
Keywords: Trilaciclib
Envafolimab
NSCLC
Second-line Treatment
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of Envafolimab Plus Docetaxel in combination with or without Trilaciclib versus docetaxel IN patients with advanced non-small cell lung cancer previously treated with a PD-1 inhibitor combined with chemotherapy

Detailed description: Trilaciclib indication: Trilaciclib, a CDK4/6 inhibitor, was used before chemotherapy to reduce the incidence of bone marrow suppression, approved by FDA and NMPA for small cell lung cancer in 2021 and in 2022.

Envafolimab indication: Envafolimab, a PD-L1 inhibitor, was used for unresectable or metastatic, MSI-H or dMMR, Adult patients with advanced solid tumors, approved by NMPA in 2021.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged≥ 18 years old
* Metastatic or advanced (stage IV) NSCLC confirmed by tissue or pathology
* Patients with advanced NSCLC who had previously failed treatment with platinum-containing chemotherapy combined with PD-1 inhibitor
* Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).,and has at least one measurable lesion
* Patients with asymptomatic brain metastasis or whose symptoms are stable after treatment
* Patients who responded to initial therapy or whose disease was stable for at least 3 months
* Laboratory tests met the following criteria:

  1. Hemoglobin (Hb)≥100 g/L(female), ≥110g/L(male)
  2. Neutrophils (ANC)≥1.5×109/L
  3. platelet count (PLT)≥100×109/L
  4. Cr≤ 15mg/L or CrCl≥ 60 mL/min
  5. TBIL≤ 1.5×ULN
  6. ALT and AST ≤ 3 × ULN or ≤5× ULN(patients with liver metastases)
  7. Albumin ≥ 30 g/L
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1
* Estimated life expectancy of more than 12 weeks
* Women: All women with potential fertility must have negative serum pregnancy tests during the screening period and must have reliable contraception after signing the informed consent form until 3 months after the last dose
* Already signed an informed consent form

Exclusion Criteria:

* Diagnosis of other malignancies than NSCLC within 5 years prior to the first dose administration (excluding radically treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ)
* Toxicity not recovered to ≤ Grade 1 from prior anticancer therapy
* Previous treatment with PD-L1 inhibitors
* ≥grade 3 immune-related adverse reactions have occurred during previous PD-1 inhibitors treatment
* Patients with known or suspected interstitial pneumonia
* Patients with known positive driving genes(EGFR,ALK,ROS1)
* Have used or requirement of treatment with prednisone \> 10 mg/day or equivalent systemic corticosteroids within 14 days prior to the first dose of study drug
* Administration of live attenuated vaccines within 28 days prior to the first study drug treatment or planned administration during the study
* Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA grade III or IV)
* Have stroke or cardiovascular events within 6 months prior to enrollment
* QTcF\>480 msec or QTcF\>500 msec(patients with ventricular pacemakers)
* Patients who have received hematopoietic stem cell or bone marrow transplants
* Allergic to the study drug or its ingredients
* Any other circumstances in which the researcher believes that the patient is not suitable to participate in this study

Primary outcomes:
measure: PFS
timeFrame: 12 months after the last subject participating in
Secondary outcomes:
measure: ORR
timeFrame: 12 months after the last subject participating in
measure: DCR
timeFrame: 12 months after the last subject participating in
measure: DoR
timeFrame: 12 months after the last subject participating in
measure: OS
timeFrame: 24 months after the last subject participating in
measure: QOL
timeFrame: 24 months after the last subject participating in
measure: The incidence of Subjects With Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
timeFrame: 24 months after the last subject participating in
Other outcomes:
Locations:
Study officials:
affiliation: Fudan University
name: Wang Jialei, doctor
role: STUDY_CHAIR
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