Efficacy and Safety of IBI308 and Paclitaxel/Albumin Paclitaxel for SCLC Patients Who Failed Etoposide Chemotherapy

NCT04056949 | Unknown Phase 2 FDA Drug

• 1 other identifier: NCC1977
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well IBI308 combined with paclitaxel/albumin-bound paclitaxel work in treating participants with small cell lung cancer after failing to platinum-etoposide chemotherapy.

Conditions

Extensive-Stage Small Cell Lung Cancer

Keywords

SCLC

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  12 months

Secondary Outcomes (4)

• overall survival (OS)

  12 months

• disease control rate (DCR)

  12 months

• durative time of remission ( DoR）

  12 months

• objective remission rate (ORR)

  12 months

Study Arms (1)

IBI308 + Paclitaxel/Albumin-Bound Paclitaxel

OTHER

IBI308 Combined with Albumin-Bound Paclitaxe

Drug: Paclitaxel/Albumin-Bound Paclitaxel; Drug: IBI308

Interventions

Paclitaxel/Albumin-Bound Paclitaxel DRUG

Paclitaxel 175mg/m2 IV on day 1of 21 days cycle ;Number of Cycles: 4-6; or Albumin-bound paclitaxel 130mg/m2 IV on day 1 and 8 of 21 days cycle ;Number of Cycles: 4-6;

IBI308 + Paclitaxel/Albumin-Bound Paclitaxel

IBI308 DRUG

IBI308 200mg IV infusion, every 3 weeks,until disease progress or intolerable toxicity,used up to 1 year (or 16 cycles)

IBI308 + Paclitaxel/Albumin-Bound Paclitaxel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent;
• Over 18 years old and below 70 years old;
• Histologically confirmed small-cell lung cancer;
• Extensive disease(ED) according to the criteria of the Veteran's Administration Lung Cancer Group: (disease extended is defined as a disease beyond hemi thorax and supraclavicular lymph node areas.);
• ED-SCLC treated with platinum-etoposide chemotherapy ,followed by disease progression or recurrence.
• Availability of a biomarker detection tissue biopsy is required;
• Eastern Cooperative Oncology Group (ECOG) performance status 0\~1;
• Life expectancy of greater than 12 weeks;
• Participants may have evaluable or measurable disease, defined as at least one lesion（no previous radiotherapy）that can be accurately measured in at least one dimension with spiral CT scan, MRI within the past 28 days;
• Women of child-bearing potential and men must agree to use adequate contraception prior to initiation of therapy and until to 6 month after this study;
• White blood cell ≥ 3.5 × 109/L, absolute neutrophil count ≥1.5 × 109/L, platelet ≥100× 109/L and hemoglobin ≥9.0 g/dL;
• Aspartate transferase,alanine aminotransferase ≤ 2.5 x ULN except in case of liver metastases (5 x ULN); Total bilirubin ≤1.5 x ULN except in case of Gilbert syndrome (3.0 mg/dL); Albumin≥3 g/dL;
• Serum creatinine ≤1.5×ULN OR creatinine clearance≥40 mL/min;
• Lipase \< 1.5 x ULN except in case of having no clinical or imaging evidence of pancreatitis; Amylase ≤1.5 x ULN except in case of having no clinical or imaging evidence of pancreatitis; Alkaline phosphatase (ALP) ≤ 2.5 ULN except in case of bone metastasis;

You may not qualify if:

• Mixed lung cancer or other types of lung cancer;
• Prior immunotherapy, included but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors or other drugs targeting T cells;
• Received high-dose radiation therapy in thoracic field within the past 6 months, Dt (\> 30 Gy);
• Active or untreated central nervous system (CNS) metastases;
• Patients with cytologically positive pleural, peritoneal or pericardial fluid are not eligible;
• History of autoimmune disease.Patients with a history of hypothyroidism origin autoimmune treated with a stable dose replacement therapy may be eligible for this study. Patients with controlled type 1 diabetes treated with insulin are eligible in this study;
• Corticosteroid with a daily dose over 10 mg prednisolone or other immunosuppressive agents were used within 14 days before the first cycle;
• Patients should not receive a vaccine during the four weeks preceding the day 1 of cycle 1, and shall not receive a vaccine during the study;
• Idiopathic pulmonary fibrosis history, radioactive pneumonia requiring steroid therapy, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced lung disease, idiopathic pulmonary or active signs of pneumonia or interstitial lung infiltrate (any cause) detected on the lung scan selection;
• History of active Bacillus Tuberculosis;
• Except hair loss and fatigue, toxicities caused by previous anti-cancer therapies need to be restored to \< CTCAE 4.03 grade 1 before starting treatment on protocol;
• History of any one or more of the following conditions within the past 6 months:symptomatic peripheral vascular disease, pulmonary embolism or untreated deep venous thrombosis (DVT), cerebrovascular accident or transient ischemic attack;
• History of any one or more of the following conditions within the past 6 months: gastrointestinal ulcer, gastrointestinal perforation, corrosive esophagitis or gastritis, inflammatory bowel disease or diverticulitis, abdominal fistula, tracheoesophageal fistula or abdominal abscess;
• History of any one or more of the following cardiovascular conditions: Class III or IV congestive heart failure, as defined by the New York Heart Association; Unstable angina; Myocardial infarction within the past 6 months; Supraventricular or ventricular arrhythmia requires treatment or intervention;
• Severe uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100mmHg);

Sponsors & Collaborators

• Junling Li: lead

Study Sites (1)

Junling Li

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Albumin-Bound Paclitaxel; sintilimab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Junling Li, doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junling Li, doctor

CONTACT

+86 13801178891; lijunling@cicams.ac.cn

Study Design

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

Model Details: SCLC patients who have failed platinum-etoposide chemotherapy

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 14, 2019
• Study Start: August 5, 2019
• Primary Completion: February 1, 2021
• Study Completion: December 31, 2021
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

CN (1)