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

June 16, 2023 updated by: Jialei Wang, Fudan University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

132

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trilaciclib+Envafolimab+Docetaxel
Trilaciclib:240mg/m2 IV d1,within 4h before chemotherapy; Envafolimab:300mg SC d1,Q3W; Docetaxel:75mg/m2 IV d1, Q3W
Drug: Trilaciclib+Envafolimab+Docetaxel
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.
Experimental: Envafolimab+Docetaxel
Envafolimab:300mg SC d1,Q3W; Docetaxel:75mg/m2 IV d1, Q3W
Drug: Envafolimab+Docetaxel
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.
Experimental: Docetaxel
Docetaxel: 75mg/m2 IV d1, Q3W
Drug: Docetaxel
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 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.
12 months after the last subject participating in

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 12 months after the last subject participating in
The proportion of subjects with complete response (CR) and partial response (PR) in total subjects.
12 months after the last subject participating in
DCR
Time Frame: 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.
12 months after the last subject participating in
DoR
Time Frame: 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.
12 months after the last subject participating in
OS
Time Frame: 24 months after the last subject participating in
Defined as the time from randomization to all-cause death.
24 months after the last subject participating in
QOL
Time Frame: 24 months after the last subject participating in
Quality of life was assessed using the EQ-5D-5L scale
24 months after the last subject participating in
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
Time Frame: 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
24 months after the last subject participating in

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Study Chair: Wang Jialei, doctor, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

June 10, 2023

First Submitted That Met QC Criteria

June 16, 2023

First Posted (Estimated)

June 19, 2023

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMA-NSCLC-012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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