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

NCT ID: NCT05910034

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2026-06-30

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.

Conditions

Advanced Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trilaciclib+Envafolimab+Docetaxel

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

Group Type: EXPERIMENTAL

Trilaciclib+Envafolimab+Docetaxel

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Envafolimab+Docetaxel

Intervention Type: DRUG

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

Docetaxel: 75mg/m2 IV d1, Q3W

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Jialei Wang

professor of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wang Jialei, doctor

Role: STUDY_CHAIR

Fudan University

Central Contacts

Wang Jialei, doctor

Role: CONTACT

luwangjialei@126.com

021-6417 5590

References

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Other Identifiers

SMA-NSCLC-012

Identifier Type: -

Identifier Source: org_study_id