Envafolimab Plus Docetaxel In Combination With or Without Trilaciclib Versus Docetaxel in Advanced NSCLC

Fudan University

Status and phase: Not yet enrolling; Phase 2

Conditions: Advanced Non-Small Cell Lung Cancer

Treatments: Drug: Envafolimab+Docetaxel; Drug: Docetaxel; Drug: Trilaciclib+Envafolimab+Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT05910034

SMA-NSCLC-012

Details and patient eligibility

About

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

Full 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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 3 patient groups

Trilaciclib+Envafolimab+Docetaxel

Experimental group

Description:

Trilaciclib:240mg/m2 IV d1,within 4h before chemotherapy; Envafolimab:300mg SC d1,Q3W; Docetaxel:75mg/m2 IV d1, Q3W

Treatment:

Drug: Trilaciclib+Envafolimab+Docetaxel

Envafolimab+Docetaxel

Experimental group

Description:

Envafolimab:300mg SC d1,Q3W; Docetaxel:75mg/m2 IV d1, Q3W

Treatment:

Drug: Envafolimab+Docetaxel

Docetaxel

Experimental group

Description:

Docetaxel: 75mg/m2 IV d1, Q3W

Treatment:

Drug: Docetaxel