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

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

NCT ID: NCT05910034

Condition: Advanced Non-Small Cell Lung Cancer

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Docetaxel

Conditions: Keywords:
Trilaciclib
Envafolimab
NSCLC
Second-line Treatment

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Trilaciclib+Envafolimab+Docetaxel
Description: This is a multi-arm, randomized, controlled, multicenter, Phase II clinical study. Participants randomly assigned at a 1:1:1 ratio to three groups, and will be treated until disease progression, intolerance, withdrawal of consent or completion determined by the investigator.
Arm group label: Trilaciclib+Envafolimab+Docetaxel

Intervention type: Drug
Intervention name: Envafolimab+Docetaxel
Description: This is a multi-arm, randomized, controlled, multicenter, Phase II clinical study. Participants randomly assigned at a 1:1:1 ratio to three groups, and will be treated until disease progression, intolerance, withdrawal of consent or completion determined by the investigator.
Arm group label: Envafolimab+Docetaxel

Intervention type: Drug
Intervention name: Docetaxel
Description: This is a multi-arm, randomized, controlled, multicenter, Phase II clinical study. Participants randomly assigned at a 1:1:1 ratio to three groups, and will be treated until disease progression, intolerance, withdrawal of consent or completion determined by the investigator.
Arm group label: Docetaxel

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: July 1, 2023

Completion date: June 30, 2026

Lead sponsor:
Agency: Fudan University
Agency class: Other

Source: Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05910034