Envafolimab Combined With Chemotherapy and Recombinant Human Endostatin in the First-line Treatment of Sq-NSCLC

NCT05243355 | Unknown Phase 2

• 1 other identifier: SMA-NSCLC-005
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, single arm, multicenter phase II study aimed at evaluating the efficacy and safety of Envafolimab combined with standard platinum containing dual drug chemotherapy and Recombinant Human Endostatin in patients with advanced (stage IIIB-IV) squamous non-small cell lung cancer.

Conditions

Squamous Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 1 year PFS rate

  12-month progression free survival in ITT population

  12 months after the last subject participating in

Secondary Outcomes (4)

• ORR

  24 months after the last subject participating in

• DOR

  24 months after the last subject participating in

• PFS

  24 months after the last subject participating in

• OS

  24 months after the last subject participating in

Study Arms (1)

"Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin"

EXPERIMENTAL

Envafolimab: 300 mg，D1，Q3W, until PD or intolerable toxicity. Paclitaxel / NAB-Paclitaxel, 175 / 260mg / m2, D1, Q3w. Cisplatin: 75mg / m2, 1-3 days, or carboplatin: AUC 5, D1, Q3w, 4-6 cycles. Recombinant Human Endostatin：210mg，CIV 72h，d1-3，Q3W，4-6 cycles in total.

Drug: "Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin"

Interventions

"Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin" DRUG

Envafolimab: 300 mg，D1，Q3W,until PD or intolerable toxicity Chemotherapy: Paclitaxel / NAB-Paclitaxel, 175 / 260mg / m2, D1, Q3w; Cisplatin: 75mg / m2, 1-3 days, or carboplatin: AUC 5, D1, Q3w, 4-6 cycles in total. Recombinant Human Endostatin：210mg，CIV 72h，d1-3，Q3W，4-6 cycles in total.

"Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin"

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent；
• Aged 18-75 years old；
• Histologically or cytologically confirmed, locally advanced (Stage IIIB/C) not amenable to curative surgery or radiotherapy, or metastatic/recurrent (Stage IV) squamous NSCLC according to American Joint Committee on Cancer, 8th Edition；
• At least 1 measurable lesion as defined by RECIST v1.1；
• ECOG performance status 0-1；
• No systematic antitumor treatment for advanced / metastatic diseases has been received in the past；
• Life expectancy sup 3 months；
• Adequate organ function；
• For female subjects of childbearing age, urine or serum pregnancy test shall be conducted 3 days before receiving the first study drug administration, and the result is negative；
• The subject and the subject's sexual partner need to use a medically approved contraceptive measure during the study treatment period and within 6 months after the end of the study treatment period.

You may not qualify if:

• Histology was non squamous cell NSCLC. Mixed cell types must distinguish the dominant cell morphology (squamous cell carcinoma components \> 50% can be included in the group); If there are small cell carcinoma, neuroendocrine carcinoma and sarcoma, they can not be included in the group;
• EGFR sensitive mutations or ALK rearrangements;
• Imaging (CT or MRI) showed that the tumor invaded large blood vessels or it was judged that the tumor was very likely to invade important blood vessels and cause fatal bleeding during the follow-up study;
• Concurrent participation in another clinical trial;
• Have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or co inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137);
• Received Chinese patent medicine with anti-tumor indications or drugs with immunomodulatory effect (thymosin, interferon, interleukin, etc.) within 2 weeks, or major surgical treatment within 3 weeks before the first administration;
• There are active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction and peritoneal metastasis that need clinical intervention;
• Grade III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmia;
• Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before enrollment;
• Known allergic reactions to PD-1/L1 monoclonal antibodies, taxanes, cisplatin or carboplatin, recombinant human endostatin active ingredients and or any excipients;
• Patients requiring long-term systemic use of corticosteroids;
• Symptomatic central nervous metastasis;
• Active infection requiring treatment or systemic anti infective drugs used within one week before the first administration;
• Not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e. ≤ grade 1 or reaching baseline, excluding fatigue or hair loss);
• Known HIV infection;

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (2)

Qilu hospital of Shandong univertisy

Jinan, Shandong, 250012, China

RECRUITING

Shandong Cancer Hospital

Jinan, China

NOT YET RECRUITING

MeSH Terms

Interventions

envafolimab; Drug Therapy; Endostatins

Intervention Hierarchy (Ancestors)

Therapeutics; Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Central Study Contacts

Lian Liu, Doctor

CONTACT

18560082903; tounao@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: February 17, 2022
• Study Start: December 3, 2021
• Primary Completion: December 3, 2023
• Study Completion: December 3, 2024
• Last Updated: February 17, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)