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

NCT05910034 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2023-06-18

No results posted yet for this study

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

Conditions

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Wang Jialei, doctor · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2025-12-30
Completion
2026-06-30

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05910034 on ClinicalTrials.gov