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

Phase 2

Not yet recruiting

• Conditions: Advanced Non-Small Cell Lung Cancer
• Interventions: Drug: Trilaciclib+Envafolimab+Docetaxel; Drug: Envafolimab+Docetaxel; Drug: Docetaxel

• Registration Number: NCT05910034
• Lead Sponsor: Fudan University

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.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-10
• Study First Submitted QC: 2023-06-16
• Last Update Submitted: 2023-06-16
• Study First Posted: 2023-06-18
• Last Update Posted: 2023-06-18
• Study Start: 2023-07-01
• Primary Completion: 2025-12-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
PFS	12 months after the last subject participating in	Progression-free survival (PFS per RECIST 1.1) is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
DoR	12 months after the last subject participating in	DoR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
ORR	12 months after the last subject participating in	The proportion of subjects with complete response (CR) and partial response (PR) in total subjects.
DCR	12 months after the last subject participating in	The proportion of subjects with complete response (CR), partial response (PR)and stable disease in(SD) in total subjects.
OS	24 months after the last subject participating in	Defined as the time from randomization to all-cause death.
QOL	24 months after the last subject participating in	Quality of life was assessed using the EQ-5D-5L scale
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	24 months after the last subject participating in	TEAEs will be defined as the adverse events (AEs) that occur between first dose of study drug administration and 28 days after the last dose of study drug administration