Anlotinib Plus Sintilimab for NSCLC Patients With First-generation EGFR-TKIs Drug Resistance Along With T790M Negative

NCT03765775 | Unknown Phase 2 DMC

• 1 other identifier: LC01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is an efficacy and safety study of Anlotinib combined with Sintilimab (IBI 308) in participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have received first-generation EGFR-TKIs resistance along with T790M negative.

Conditions

Carcinoma; Non-small Cell Lung Cancer; Lung Neoplasm

Keywords

Non-small Cell Lung Cancer; Anlotinib; Sintilimab

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent central radiologists' (BICR) review. Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. (Note: the appearance of one or more new lesions was also considered progression). Participants were evaluated every 9 weeks with radiographic imaging to assess their response to treatment.

  6 months

Secondary Outcomes (2)

• Over Survival(OS)

  2years

• Objective Response Rate (ORR)

  2yeas

Study Arms (1)

Anlotinib Hydrochloride+Sintilimab

EXPERIMENTAL

Participants receive Sintilimab (IBI 308) 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle , Anlotinib 12mg, administered as PO on Day1-14 of each 21-day cycle until documented PD

Biological: Sintilimab; Drug: Anlotinib Hydrochloride

Interventions

Sintilimab BIOLOGICAL

Participants receive Sintilimab(IBI 308) 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle

Anlotinib Hydrochloride+Sintilimab

Anlotinib Hydrochloride DRUG

Participants receive Anlotinib 10 mg, administered as PO on Day 1-14 of each 21-day cycle

Also known as: Anlotinib

Anlotinib Hydrochloride+Sintilimab

Eligibility Criteria

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

You may qualify if:

• The subjects volunteered to participate in this study and signed the informed consent form, with good compliance and follow-up.
• Male or female patients aged 18-75 years old.
• Has a histologically-confirmed or cytologically confirmed diagnosis of stage IV nonsquamous NSCLC.
• Has confirmation that epidermal growth factor receptor (EGFR) mutation，with first-generation EGFR-TKIs drug resistance T790M negative .
• Has measurable disease.
• There is at least one target lesion that has not received radiotherapy in the past 3 months, and it can be accurately measured in at least one direction (the maximum diameter needs to be recorded) by magnetic resonance imaging (MRI) or computed tomography (CT), in which conventional CT is greater than 20mm or spiral CT is greater than 10mm.
• Has a life expectancy of at least 3 months.
• Has a performance status of 0 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
• Has adequate organ function.
• Patients with asymptomatic or mild brain metastasis may be enrolled.
• If female of childbearing potential, is willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents.
• If male with a female partner(s) of child-bearing potential, must agree to use adequate contraception starting with the first dose of study medication through 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents.

You may not qualify if:

• \. Squamous cell carcinoma (including adenosquamous carcinoma);Small cell lung cancer (including small cell cancer and non-small cell mixed lung cancer).
• ALK(Anaplastic Lymphoma kinase) positive. 3.Imaging (CT or MRI) showed that the tumor lesion invaded the central tumor of local large blood vessels;Or there is obvious pulmonary cavitation or necrotic tumor.
• History and complications
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.(patients with brain metastasis who have completed treatment 14 days before enrollment and have stable symptoms can be included in the group, but they need to be confirmed as having no symptoms of cerebral hemorrhage by brain MRI, CT).
• Have Participated in other clinical studies or less than 4 weeks before the end of treatment in the previous clinical study.
• Other active malignancies requiring concurrent treatment.
• Known history of prior malignancy except if participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy, except for successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
• Patients who have not recovered to level 1 or lower of NCI-CTCAE4.0 （The Common Terminology Criteria for Adverse Events 4.0）after previous systemic anti-tumor treatment with anti-tumor treatment-related adverse reactions (except hair loss).
• Abnormal coagulation function (INR(international normalized ratio) \>1.5 or PT(prothrombin time) \> ULN+4 s or APTT(activated partial thromboplastin time ) \> 1.5ULN), with bleeding tendency or receiving thrombolytic or anticoagulant treatment.
• Is expected to require any other form of antineoplastic therapy while on study.
• Received a live-virus vaccination within 30 days of planned start of study medication.
• Known sensitivity to any component of Anlotinib or Sintilimab.
• Has active autoimmune disease that has required systemic treatment in past 2 years.
• Is on chronic systemic steroids.
• Has an active infection requiring therapy.

Sponsors & Collaborators

• First Hospital of Shijiazhuang City: lead

Study Sites (1)

The First Hospital of Shijiazhuang

Shijiazhuang, Hebei, 050011, China

RECRUITING

MeSH Terms

Conditions

Carcinoma; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

sintilimab; anlotinib

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yan Zhang, M.D.

  The First Hospital of Shijiazhuang

  STUDY CHAIR

Central Study Contacts

Yan Zhang, M.D.

CONTACT

17603119607; 13315978836@163.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 4, 2018
• First Posted: December 5, 2018
• Study Start: November 20, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2021
• Last Updated: December 6, 2018

Record last verified: 2018-12

Locations

CN (1)