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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04056949
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Information provided by (Responsible Party):
Junling Li, Peking Union Medical College

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.

Condition or disease Intervention/treatment Phase
Extensive-Stage Small Cell Lung Cancer Drug: Paclitaxel/Albumin-Bound Paclitaxel Drug: IBI308 Phase 2

Detailed Description:

Primary objective :

To estimate progression free survival (PFS) probability of patient who recurrent SCLC treated with IBI308 combined with paclitaxel/abumin-bound paclitaxel following progression on platinum-etoposide chemotherapy.

Secondary Objectives:

I.To evaluate the objective remission rate (ORR), disease control rate. (DCR),durative time of remission ( DoR)and overall survival (OS) of IBI308 combined with paclitaxel/abumin-bound paclitaxel following progression on platinum-etoposide chemotherapy.

II.To evaluate the safety of IBI308 combined with paclitaxel/abumin-bound paclitaxel following progression on platinum-etoposide chemotherapy.

Exploratory Objectives To evaluate the correlation of biomarkers with efficacy and toxicity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: SCLC patients who have failed platinum-etoposide chemotherapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of IBI308 Combined With Paclitaxel/Albumin-Bound Paclitaxel as Second-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer That Relapsed After Failing to Platinum-Etoposide Chemotherapy
Actual Study Start Date : August 5, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
IBI308 + Paclitaxel/Albumin-Bound Paclitaxel
IBI308 Combined with Albumin-Bound Paclitaxe
Drug: Paclitaxel/Albumin-Bound Paclitaxel
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;

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

Primary Outcome Measures :
  1. progression-free survival (PFS) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. overall survival (OS) [ Time Frame: 12 months ]
  2. disease control rate (DCR) [ Time Frame: 12 months ]
  3. durative time of remission ( DoR) [ Time Frame: 12 months ]
  4. objective remission rate (ORR) [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Signed informed consent;
  2. Over 18 years old and below 70 years old;
  3. Histologically confirmed small-cell lung cancer;
  4. 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.);
  5. ED-SCLC treated with platinum-etoposide chemotherapy ,followed by disease progression or recurrence.
  6. Availability of a biomarker detection tissue biopsy is required;
  7. Eastern Cooperative Oncology Group (ECOG) performance status 0~1;
  8. Life expectancy of greater than 12 weeks;
  9. 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;
  10. 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;
  11. White blood cell ≥ 3.5 × 109/L, absolute neutrophil count ≥1.5 × 109/L, platelet ≥100× 109/L and hemoglobin ≥9.0 g/dL;
  12. 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;
  13. Serum creatinine ≤1.5×ULN OR creatinine clearance≥40 mL/min;
  14. 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;

Exclusion Criteria:

  1. Mixed lung cancer or other types of lung cancer;
  2. 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;
  3. Received high-dose radiation therapy in thoracic field within the past 6 months, Dt (> 30 Gy);
  4. Active or untreated central nervous system (CNS) metastases;
  5. Patients with cytologically positive pleural, peritoneal or pericardial fluid are not eligible;
  6. 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;
  7. Corticosteroid with a daily dose over 10 mg prednisolone or other immunosuppressive agents were used within 14 days before the first cycle;
  8. 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;
  9. 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;
  10. History of active Bacillus Tuberculosis;
  11. 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;
  12. 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;
  13. 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;
  14. 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;
  15. Severe uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100mmHg);
  16. Tumors compress surrounding vital organs, such as the esophagus, with associated symptoms;
  17. Uncontrolled hypercalcemia;
  18. History of allergic reactions attributed to compounds of similar chemical or biologic composition to monoclonal antibody;
  19. Prior malignancy. Note: Patients who have had another malignancy and were treated more than 5 years ago and have since been considered cured, or patients with a history of basocellular skin carcinoma or in situ carcinoma of the uterine cervix are eligible;
  20. Mental illness, alcoholism, inability to quit smoking, drug abuse or drug abuse;
  21. History of human immunodeficiency virus infection or has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C Virus (HCV) (e.g., HCV RNA is detected).
  22. Pregnant or lactating female;
  23. Any type of systemic anticancer therapy (chemotherapy or experimental drugs) within 4 weeks of starting treatment on protocol;
  24. Other situations judged by researchers;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04056949

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Contact: Junling Li, doctor +86 13801178891

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China, Beijing
Junling Li Recruiting
Beijing, Beijing, China, 100021
Contact: Junling Li, Doctor    +86 13801178891   
Sponsors and Collaborators
Junling Li
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Principal Investigator: Junling Li, doctor Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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Responsible Party: Junling Li, Clinical Professor, Peking Union Medical College Identifier: NCT04056949     History of Changes
Other Study ID Numbers: NCC1977
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Junling Li, Peking Union Medical College:
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors