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Efficacy and Safety Evaluation of Sintilimab in Patients With Advanced or Recurrent Squamous NSCLC

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. Read our disclaimer for details. Identifier: NCT03629925
Recruitment Status : Active, not recruiting
First Posted : August 14, 2018
Last Update Posted : April 14, 2020
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary:
Efficacy and Safety Evaluation of IBI308 in Patients with Advanced or Recurrent Squamous NSCLC

Condition or disease Intervention/treatment Phase
Squamous NSCLC Drug: Sintilimab Drug: Gemcitabine Drug: Placebo Drug: Platinum Phase 3

Detailed Description:
The anti-tumor activity of anti-PD-1 therapy in previously untreated Chinese squamous NSCLC patients will be investigated in this clinical trial. Sintilimab is expected to increase the PFS from 5.5 months to 7.9 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Phase III Study of Gemcitabine +Carboplatin/Cisplatin Chemotherapy With or Without Sintilimab in First Line Metastatic Squamous Non-small Cell Lung Cancer Subjects (Orient-12)
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sintilimab+ gemcitabine plus platinum
Experimental: Sintilimab Injection (Dosage form:10ml:100mg; Frequency: 200mg Q3W; Duration: until first documented tumor progression per RECIST v1.1 criteria) Sintilimab 200mg + gemcitabine plus platinum for 4 cycles followed by Sintilimab 200mg Q3W until first documented tumor progression per RECIST v1.1 criteria
Drug: Sintilimab
10 mL:100 mg,200mg,Q3W, day1, I.V.
Other Name: IBI308

Drug: Gemcitabine
1000mg/m^2,D1D8/Q3W;first 4 cycles.

Drug: Platinum
Q3W, day1, I.V.; first 4 cycles.

Placebo Comparator: Placebo+gemcitabine plus platinum
Placebo + gemcitabine plus platinum Q3W for 4 cycles followed by placebo (Conditional crossover to sintilimab 200mg Q3W)
Drug: Gemcitabine
1000mg/m^2,D1D8/Q3W;first 4 cycles.

Drug: Placebo
10 mL:100 mg,200mg,Q3W, day1, I.V.

Drug: Platinum
Q3W, day1, I.V.; first 4 cycles.

Primary Outcome Measures :
  1. PFS(progression free survival) [ Time Frame: up to 24 months after randomization ]
    PFS was defined as the time from the date of randomization to the date of the first documented tumor progression per RECIST v1.1 criteria

Secondary Outcome Measures :
  1. OS (overall survival) [ Time Frame: up to 24 months after randomization ]
    OS was defined as the time between the date of randomization and the date of death from any cause.

  2. ORR(objective response rate) [ Time Frame: up to 24 months after randomization ]
    Objective response is defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment(per RECIST v1.1).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Signed written informed consent before any trial-related processes;
  2. Age ≥ 18 years and <75 years;
  3. Life expectancy exceeds 3 months;
  4. The investigator confirms at least one measurable lesion according to RECIST 1.1.

    A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if progression is confirmed;

  5. Has a histologically or cytologically confirmed stage IIIB/IIIC (American Joint Committee on Cancer [AJCC] 8th edition) NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic / recurrent squamous NSCLC;
  6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
  7. Has not received any systematic anti-tumor treatment for advanced disease. The patient may have received adjuvant chemotherapy as long as the disease progresses at least 6 months after the last dose of chemotherapy;
  8. Adequate hematologic function, defined as absolute neutrophil count ≥1.5×109 /L, platelet count ≥100 ×109 /L, hemoglobin ≥9g/dL (no blood transfusion within 7 days);
  9. Adequate liver function, defined as total bilirubin levels ≤ 1.5 times normal upper limit (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN, or AST and ALT levels ≤ 5 times ULN for patients with hepatic metastasis;
  10. Adequate renal function, defined as serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 50 ml / min (Cockcroft-Gault formula);
  11. Coagulation function is adequate, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times normal upper limit (ULN). If the subject is receiving anticoagulant therapy, the INR/PT level is required to be within the therapeutic scope;
  12. Urine or serum pregnancy test should be negative for female subjects of childbearing age. If the urine pregnancy test results are positive or cannot be confirmed, a blood pregnancy test is required;
  13. Male and female patients with childbearing potential are required to use high-efficiency contraception until at least 180 days after stopping the trial treatment;

Exclusion Criteria:

  1. Non-squamous cell-dominated NSCLC. If small cell types are present, the subject is not eligible for inclusion;
  2. Patients with known EGFR-sensitive mutations or ALK rearrangements;
  3. Currently participating in or has participated in other interventional clinical study within 4 weeks;
  4. Has previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or any other stimulatory or inhibitory agents of T cell receptors (eg CTLA-4, OX-40, CD137);
  5. Has received a traditional Chinese medicine with anti-tumor effect, or any immunomodulatory drug (thymosin, interferon, interleukin) within 2 weeks, or received major surgery within 3 weeks;
  6. Clinical active diverticulitis, abdominal abscess, gastrointestinal obstruction and peritoneal metastasis;
  7. Has received a organ or blood system transplantation;
  8. Clinically uncontrollable pleural effusion/peritoneal effusion;
  9. Known to have severe allergic reactions (≥3 grade) to Sintilimab, gemcitabine, cisplatin or carboplatin;
  10. Active autoimmune diseases requiring systemic treatment (eg, using a disease-modifying drug, corticosteroid or immunosuppressant) within 2 years prior to the first study treatment. Hormone replacement (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered as systemic treatments;
  11. Diagnosed of immunodeficiency or has received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drugs. Physiological doses of corticosteroids (≤10 mg/day of prednisone or equivalent) are permitted;
  12. Has not fully recovered from the toxicity and/or complications caused by any intervention before starting treatment (ie, CTCAE v4.03 Grade ≤1 or recovering to baseline, except for fatigue or alopecia);
  13. Other malignancies diagnosed within 5 years prior to the first dose of study drugs, with the exception of radically resected cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and carcinoma in situ;
  14. Active central nervous system (CNS) metastasis and/or cancerous meningitis. Patients with treated brain metastases who were clinically stable for at least 2 weeks and have no new or advanced brain metastases may be enrolled. Patients with known untreated, asymptomatic brain metastases can be enrolled provided cerebral imaging assessment be regularly performed.
  15. History of pneumonitis requiring steroid therapy or the presence of interstitial lung disease within 1 year prior to the first dose of study drugs;
  16. Presence of active infections that require systemic treatment;
  17. Any known mental illness or substance abuse that may have an impact on compliance with the test requirements;
  18. History of human immunodeficiency virus (HIV) infection (ie, HIV 1/2 antibody positive).
  19. Untreated active hepatitis B;
  20. Active HCV infection (HCV antibody positive and HCV-RNA levels above the lower limit of detection);
  21. Vaccination with live attenuated vaccines within 30 days prior to first dose of study drug; Note: Inactivated virus vaccines for seasonal influenza, injectable drugs are permitted; however, live attenuated influenza vaccines (such as FluMist®) are not allowed;
  22. Any illness or disease evidence, treatment or laboratory abnormalities that may interfere with the subject's full participation in the study, or any condition that, in the investigator opinion, is not in the best interest of the subject.

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): NCT03629925

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Shanghai Pulmonary Hospital
Shanghai, China
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd. Identifier: NCT03629925    
Other Study ID Numbers: CIBI308C303
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs