A Study of Combination Therapy in NSCLC

NCT04544644 | Unknown Phase 2

• 1 other identifier: IIT-001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial is a single arm, two cohorts, phase II study. All patients are stage IIIB-IV NSCLC, Eastern Cooperative Oncology Group (ECOG) performance status 0-1 and no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the anaplastic lymphoma kinase gene. Cohort 1 includes patients with metastatic or recurrent NSCLC after progression on treatment with platinum-based chemotherapy and PD-1/PD-L1, given concurrently or sequentially. Cohort 2 includes treatment naïve patients with advanced NSCLC. All patients will recieve AK104 15mg/kg every 3 weeks(for up to 2 years) and anlotinib(12mg/d). The primary end point are objective response rate per RECIST1.1 and safety. Secondary end points are progression-free survival and overall survival.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  objective response rate per RECIST1.1

  through study completion, an average of 1 year

Secondary Outcomes (1)

• PFS and OS

  through study completion, an average of 2 years

Study Arms (1)

treatment arm

EXPERIMENTAL

AK104+anlotinib

Drug: AK104+anlotinib

Interventions

AK104+anlotinib DRUG

AK 104 is given by intravenous infusion and anlotinib is given by oral.

treatment arm

Eligibility Criteria

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

You may qualify if:

• Aged 18 to 75 years old (at the time consent is obtained);
• Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures);
• Have histologically- or cytologically-confirmed diagnosis of StageIIIB/C or IV NSCLC;

You may not qualify if:

• EGFR/ALK negative;
• Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy;
• Have a life expectancy of at least 3 months;
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the site study team;
• Has adequate organ function as defined by: (1) Absolute neutrophil count \>= 1,500/uL; (2) Platelets \>= 100,000/uL; (3) Hemoglobin \>= 9 g/dL; (4) Crcl \>= 50ml/min; creatinine clearance may be calculated using the institutional/laboratory standard method; (5) Serum total bilirubin \<= 1.5 ULN; (6) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 2.5 ULN; (7) Albumin \>= 28g/L; (8) International Normalized Ratio (INR) and aPTT \<1.5 ULN; (9) Left ventricular ejection fraction \>= 50%;
• Have recovered from the effects of any prior radiotherapy or surgery;
• All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.
• Is currently participating in a study of an investigational agent or using an investigational device;
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within 2 years prior to the first dose of study treatment;
• Has undergone major surgery within 30 days of Study Day 1;
• Has a known additional malignancy that is progressing or requires systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
• Has known active central nervous system (CNS) metastases;
• Has carcinomatous meningitis;
• Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment NOTE: Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study;

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

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

• weiwei Shi

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

weiwei Shi

CONTACT

+86 01066875308; shiweiwei301@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 10, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: September 10, 2020

Record last verified: 2020-09