NCT05910034

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P75+ for phase_2

Timeline
1mo left

Started Jul 2023

Typical duration for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jul 2023Jun 2026

First Submitted

Initial submission to the registry

June 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

2.5 years

First QC Date

June 10, 2023

Last Update Submit

June 16, 2023

Conditions

Advanced Non-Small Cell Lung Cancer

Keywords

TrilaciclibEnvafolimabNSCLCSecond-line Treatment

Outcome Measures

Primary Outcomes (1)

  • PFS

    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 Outcomes (6)

  • ORR

    12 months after the last subject participating in

  • DCR

    12 months after the last subject participating in

  • DoR

    12 months after the last subject participating in

  • OS

    24 months after the last subject participating in

  • QOL

    24 months after the last subject participating in

  • +1 more secondary outcomes

Study Arms (3)

Trilaciclib+Envafolimab+Docetaxel

EXPERIMENTAL

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

Drug: Trilaciclib+Envafolimab+Docetaxel

Envafolimab+Docetaxel

EXPERIMENTAL

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

Drug: Envafolimab+Docetaxel

Docetaxel

EXPERIMENTAL

Docetaxel: 75mg/m2 IV d1, Q3W

Drug: Docetaxel

Interventions

Trilaciclib+Envafolimab+DocetaxelDRUG

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.

Trilaciclib+Envafolimab+Docetaxel
Envafolimab+DocetaxelDRUG

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.

Envafolimab+Docetaxel
DocetaxelDRUG

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.

Docetaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Hemoglobin (Hb)≥100 g/L(female), ≥110g/L(male)
  • Neutrophils (ANC)≥1.5×109/L
  • platelet count (PLT)≥100×109/L
  • Cr≤ 15mg/L or CrCl≥ 60 mL/min
  • TBIL≤ 1.5×ULN
  • ALT and AST ≤ 3 × ULN or ≤5× ULN(patients with liver metastases)
  • Albumin ≥ 30 g/L
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1
  • +3 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Morimoto Y, Kishida T, Kotani SI, Takayama K, Mazda O. Interferon-beta signal may up-regulate PD-L1 expression through IRF9-dependent and independent pathways in lung cancer cells. Biochem Biophys Res Commun. 2018 Dec 9;507(1-4):330-336. doi: 10.1016/j.bbrc.2018.11.035. Epub 2018 Nov 14.

    PMID: 30446226BACKGROUND

  • Travis WD, Brambilla E, Nicholson AG, Yatabe Y, Austin JHM, Beasley MB, Chirieac LR, Dacic S, Duhig E, Flieder DB, Geisinger K, Hirsch FR, Ishikawa Y, Kerr KM, Noguchi M, Pelosi G, Powell CA, Tsao MS, Wistuba I; WHO Panel. The 2015 World Health Organization Classification of Lung Tumors: Impact of Genetic, Clinical and Radiologic Advances Since the 2004 Classification. J Thorac Oncol. 2015 Sep;10(9):1243-1260. doi: 10.1097/JTO.0000000000000630.

    PMID: 26291008RESULT

  • Boyero L, Sanchez-Gastaldo A, Alonso M, Noguera-Ucles JF, Molina-Pinelo S, Bernabe-Caro R. Primary and Acquired Resistance to Immunotherapy in Lung Cancer: Unveiling the Mechanisms Underlying of Immune Checkpoint Blockade Therapy. Cancers (Basel). 2020 Dec 11;12(12):3729. doi: 10.3390/cancers12123729.

    PMID: 33322522RESULT

  • Herbst RS, Garon EB, Kim DW, Cho BC, Gervais R, Perez-Gracia JL, Han JY, Majem M, Forster MD, Monnet I, Novello S, Gubens MA, Boyer M, Su WC, Samkari A, Jensen EH, Kobie J, Piperdi B, Baas P. Five Year Survival Update From KEYNOTE-010: Pembrolizumab Versus Docetaxel for Previously Treated, Programmed Death-Ligand 1-Positive Advanced NSCLC. J Thorac Oncol. 2021 Oct;16(10):1718-1732. doi: 10.1016/j.jtho.2021.05.001. Epub 2021 May 26.

    PMID: 34048946RESULT

  • Law AMK, Valdes-Mora F, Gallego-Ortega D. Myeloid-Derived Suppressor Cells as a Therapeutic Target for Cancer. Cells. 2020 Feb 27;9(3):561. doi: 10.3390/cells9030561.

    PMID: 32121014RESULT

  • Cabrita R, Mitra S, Sanna A, Ekedahl H, Lovgren K, Olsson H, Ingvar C, Isaksson K, Lauss M, Carneiro A, Jonsson G. The Role of PTEN Loss in Immune Escape, Melanoma Prognosis and Therapy Response. Cancers (Basel). 2020 Mar 21;12(3):742. doi: 10.3390/cancers12030742.

    PMID: 32245160RESULT

  • Roselli M, Cereda V, di Bari MG, Formica V, Spila A, Jochems C, Farsaci B, Donahue R, Gulley JL, Schlom J, Guadagni F. Effects of conventional therapeutic interventions on the number and function of regulatory T cells. Oncoimmunology. 2013 Oct 1;2(10):e27025. doi: 10.4161/onci.27025.

    PMID: 24353914RESULT

MeSH Terms

Interventions

Docetaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Wang Jialei, doctor

    Fudan University

    STUDY CHAIR

Central Study Contacts

Wang Jialei, doctor

CONTACT

021-6417 5590luwangjialei@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of medicine

Study Record Dates

First Submitted

June 10, 2023

First Posted

June 18, 2023

Study Start

July 1, 2023

Primary Completion

December 30, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share