Trial of Chidamide in Combination With Envafolimab in Patients With PD-1 Inhibitor Resistant Advanced NSCLC.

NCT05068427 | Completed Phase 2 DMC

• 1 other identifier: CDM205
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 12

Brief Summary

This study is to evaluate the preliminary efficacy and safety of Chidamide combined with Envafolimab in patients with PD-1 inhibitor resistant advanced NSCLC.

Conditions

Non Small Cell Lung Cancer

Keywords

Chidamide; Envafolimab; Non Small Cell Lung Cancer; Immunotherapy Resistance

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.

  Response is assessed once every 8 weeks, assessed up to 24 weeks.

Secondary Outcomes (7)

• disease control rate (DCR)

  From the first date of response until the date of first documented progression, assessed up to 24 weeks

• duration of response (DOR)

  From the first date of response until the date of first documented progression, assessed up to 24 months

• time to progression (TTP)

  From date of randomization until the date of first documented progression, assessed up to 24 months

• time to response (TTR)

  From date of randomization until the date of first documented response, assessed up to 24 months

• progression-free survival (PFS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Study Arms (1)

Chidamide + Envafolimab

EXPERIMENTAL

Patients receive Chidamide 20mg or 30mg orally twice per week and Envafolimab 400mg subcutaneous infusions every 4 weeks untile disease progression or unacceptable toxicity.

Drug: Chidamide; Drug: Envafolimab

Interventions

Chidamide DRUG

20mg or 30mg orally twice per week(BIW)

Also known as: CS055

Chidamide + Envafolimab

Envafolimab DRUG

400mg subcutaneous infusions every 4 weeks

Also known as: KN035

Chidamide + Envafolimab

Eligibility Criteria

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

You may qualify if:

• Male or female, age ≥ 18 years.
• Histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic (stage IIIB-IV) NSCLC.
• Previously treated with a PD-1 inhibitor, alone or in combination with another systemic therapy, and have unequivocal progressive disease confirmed by imaging or pathology. The PD-1 inhibitor must be the products already in the market.
• Previously received at least 2 systemic chemotherapy regimens (containing platinum is required).
• Tumor tissue can be provided for research.
• ECOG performance status of 0 or 1.
• Have at least one measurable target lesion as defined by RECIST v.1.1.
• The following laboratory results within 7 days prior to study drug administration: Hemoglobin ≥90g/L independent of transfusion, Neutrophils ≥1.5×109/L, Platelets ≥90×109/L, Creatinine ≤1.5×ULN, Bilirubin ≤1.5×ULN (unless known Gilbert's disease where it must be ≤3×ULN), AST and ALT ≤2.5×ULN (unless known hepatic metastasis where it must be ≤5×ULN); INR≤1.5×ULN, PT and aPTT ≤1.5×ULN.
• Life expectancy ≥12 weeks.
• Have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Prior use of a PDL1 or PDL2, anti-CTLA4 antibody or any other antibody or drug that specifically targets immune checkpoint pathway.
• Prior use of HDAC inhibitor.
• Known history of intolerance to PD-1 inhibitor treatment.
• Known driver genes mutation (EGFR, ALK, ROS1 or RET).
• Use of any anti-tumor therapy or investigational agent and device within 28 days before the first dose of study drug; or received thoracic radiation \>30Gy within 6 months before the first dose.
• Use of systemic immunosuppressive therapy within 28 days before the first dose of study drug. Inhaled or topical steroids and physiological dose of systemic glucocorticoid (≤10 mg daily prednisone equivalents) are permitted.
• Received a live vaccine within 28 days before the first dose of study drug or planned to receive during the study period. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; and COVID-19 vaccine also are allowed.
• Received major surgery (craniotomy, thoracotomy or laparotomy) within 28 days before the first dose of study drug, or there are still serious and unhealed wounds, ulcers or fractures judged by the investigator during the screening period.
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• Before the first dose of study drug, subjects who has not recovered ( ≤ Grade 1 defined by CTCAE V5.0) from AEs due to prior anti-cancer therapy. Except for hair loss, or laboratory test abnormalities assessed by the investigator as clinically insignificant.
• Subjects with obvious clinical symptoms or need drainage of pleural effusion, ascites and pericardial effusion, or who received drainage for the purpose of treatment within 1 month before the first dose of study drug.
• Active autoimmune disease that has required systemic treatment in past 2 years (i.e., corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and are allowed.
• Known central nervous system (CNS) metastases and/or carcinomatous meningitis. Previously treated brain metastases may be an exception if stable and specific other criteria are met.
• Uncontrollable or major cardiovascular and cerebrovascular diseases, including, but not limited to:
• )Congestive heart failure (New York Heart Association Grade II or above); unstable angina or myocardial infarction within the previous 6 months; or cardiac arrhythmia requiring treatment; or left ventricular ejection fraction (LVEF)\<50%; 2)Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, amorphous cardiomyopathy); 3)History of clinically significant QTcF interval prolongation, or a QTcF interval \> 470 msec(female) or \> 470 msec(male) during the screening period.

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (12)

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Southern Medical University Affiliated Nanfang Hospital

Guangzhou, Guangdong, 510515, China

Location

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, 530021, China

Location

Baoding No.2 Central Hospital

Baoding, Hebei, 072750, China

Location

Henan Cancer Center

Zhengzhou, Henan, 450008, China

Location

Nantong Tumor Hospital

Nantong, Jiangsu, 226361, China

Location

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

Location

Linyi Cancer Hospital

Linyi, Shandong, 276002, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; envafolimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Li Zhang

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 5, 2021
• Study Start: November 23, 2021
• Primary Completion: February 23, 2023
• Study Completion: May 16, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)