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

• Status: Not yet recruiting
• Trial end date: 2026-06-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Docetaxel

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