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SCT-I10A or Placebo Plus Docetaxel With Previously Treated Squamous Cell Non-small Cell Lung Cancer

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.
 
ClinicalTrials.gov Identifier: NCT04171284
Recruitment Status : Active, not recruiting
First Posted : November 20, 2019
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Sinocelltech Ltd.

Brief Summary:
This is a phase 3 double-blinded randomized multicenter clinical trial of SCT-I10A or placebo plus docetaxel with previously treated squamous cell non-small cell lung cancer patients. The main endpoint is to compare the overall survival (OS) of these two regimens above.

Condition or disease Intervention/treatment Phase
Squamous-cell Non-Small-cell Lung Cancer Drug: SCT-I10 Drug: Docetaxel Drug: Placebo Phase 3

Detailed Description:
In 2015, there were near 787,000 patients diagnosed with lung cancer in China. And in the very same year, 631,000 lung cancer patients died of the disease. Lung cancer still causes most cancer related death in here. Approximately 85% of lung cancer is non-small cell lung cancer (NSCLC) compared with small cell lung cancer (~15%) pathologically. NSCLC include squamous cell NSCLC, adenocarcinoma and large cell carcinoma. Although there are therapies developed to treat the condition, patients with advanced squamous-cell (NSCLC) who have disease progression during or after first-line chemotherapy have limited treatment options in China. Hence, we developed a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor monoclonal antibody (SCT-I10A) which inhibits the interaction between PD-1 and its ligands results in the reactivation of active T cell and finally leads to caner immunotherapy. We are now carrying out a phase 3 clinical trial to determine whether SCT-I10A plus docetaxel surpass docetaxel monotherapy with previously treated squamous-cell NSCLC patients. As designed in the protocol, 360 eligible subjects would be randomized into two arms in a ratio of 2:1. 240 subjects would be treated with SCT-I10A plus docetaxel in the experimental arm while 120 subjects would be treated with placebo plus docetaxel in the active comparator arm. Both of these arms will be treated with maintenance therapy after planed treatments. Our primary endpoint is overall survival, secondary endpoints are PFS, OSR, ORR, DOR, DCR and other efficacy and safety index.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Double-blinded Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of SCT-I10A or Placebo Plus Docetaxel in Treating Advanced Squamous Non-small Cell Lung Cancer
Actual Study Start Date : October 22, 2019
Estimated Primary Completion Date : October 22, 2022
Estimated Study Completion Date : May 22, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: SCT-I10A plus Docetaxel
SCT-I10A 200mg, I.V., Q3W; Docetaxel 70-75 mg per square meters of body surface area,I.V., Q3W. Maximum of 6 cycles
Drug: SCT-I10
200 mg, Q3W, maximum treatment up to six cycles
Other Name: human PD-1 monoclonal antibody

Drug: Docetaxel
70-75mg per square meters of body surface area, Q3W, maximum treatment up to six cycles

Active Comparator: Placebo puls docetaxel
Placebo 200mg, I.V., Q3W; Docetaxel 70-75 mg per square meters of body surface area,I.V., Q3W Maximum of 6 cycles
Drug: Docetaxel
70-75mg per square meters of body surface area, Q3W, maximum treatment up to six cycles

Drug: Placebo
200 mg, Q3W, maximum treatment up to six cycles

Experimental: Maintenance therapy of SCT-I10A
Subjects complete 2-6 cycles of combined therapies, when the evaluation result is CR, PR or SD (RECIST 1.1), the subjects will enter maintain therapy: SCT-I10A 200mg, I.V., Q3W, till progression, loss to follow-up, new antineoplastic therapy or intolerable toxicity.
Drug: SCT-I10
200 mg, Q3W, maximum treatment up to six cycles
Other Name: human PD-1 monoclonal antibody

Placebo Comparator: Maintenance therapy of Placebo
Subjects complete 2-6 cycles of combined therapies, when the evaluation result is CR, PR or SD (RECIST 1.1), the subjects will enter maintain therapy: Placebo 200mg, I.V., Q3W, till progression, loss to follow-up, new antineoplastic therapy or intolerable toxicity.
Drug: Placebo
200 mg, Q3W, maximum treatment up to six cycles




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Up to approximately 3 years ]
    OS is the time from the date of randomization to death due to any cause.


Secondary Outcome Measures :
  1. PFS [ Time Frame: Up to approximately 3 years ]
    PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).

  2. OSR of 6 months, 12 months and 18 moths [ Time Frame: Each subject that randomized will be followed up for 18 months to measure the OSR. ]
    overall survival rate from the date of randomization till the 6 months,12 months and 18 months

  3. ORR [ Time Frame: Up to approximately 3 years ]
    ORR is the proportion of subjects with CR or PR based on RECIST v1.1.

  4. DOR [ Time Frame: Up to approximately 3 years ]
    DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.

  5. DCR [ Time Frame: Up to approximately 3 years ]
    DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST v1.1.

  6. The concentration of anti-SCT-I10A antibodies in the serum of subjects [ Time Frame: Up to approximately 3 years ]
    The concentration of anti-SCT-I10A antibodies in the serum of subjects during or after the study treatments will be measured, its level could indicate the immunogenicity of SCT-I10A.

  7. The expression level of PD-L1 of subjects' specimens [ Time Frame: Up to approximately 3 years ]
    The expression level of PD-L1 of the subjects would be measure by immunohistochemical detection. The results would be used to analyze the correlation of PD-L1 level and outcomes including primary and secondary endpoints including OS, PFS, OSR, ORR, DOR and DCR.

  8. Cancer-specific quality of life of the regimens treated subjects [ Time Frame: Up to approximately 3 years ]
    European Organisation for Research and Treatment of Cancer (EORTC) cancer-specific quality of life questionnaire (EORTC QLQ-C30) will be applied in all subjects to collect the score of 30 items of subjects before and after study treatments. For the items from one to twenty-eight, the minimum and maximum scores are 28 and 112 respectively and the higher score means a worse outcome. For the items from twenty-nine to thirty, the minimum and maximum raw scores are 2 and 14 respectively and the higher score means a better outcome. Further analysis could be done based on the calculation.

  9. Lung cancer-specific quality of life of the regimens treated subjects [ Time Frame: Up to approximately 3 years ]
    European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) will be applied in all subjects to collect the score of 13 specific typical symptoms of lung cancer patients before and after study treatments. The minimum and maximum raw scores are 12 and 52 respectively, the higher score means a worse outcome.



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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
Criteria

Inclusion Criteria:

  1. Patients should be voluntarily sign the written informed consent.
  2. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic squamous NSCLC. Or recurrent squamous NSCLC according UICC/AJCC 8th edition.
  3. At least one measurable tumor lesion per RECIST 1.1 criteria. A lesion previously irradiated could be considered as a target lesion only in the condition that progression occurred at the time of 3 months after the end of radiotherapy.
  4. Previously treated with one platinum based regimen (including platinum and endostar regimen) and progression occur during or after treatment or unbearable treatment related adverse events.
  5. Progression after EGFR-TKIs in patients with driver gene mutation.
  6. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.

Exclusion Criteria:

  1. Patient who is allergic to recombinant humanized PD-1 monoclonal antibody or the components of the drug.
  2. Patient who is allergic to taxane.
  3. Previously treated with any of the antibodies targeted on PD-1, PD-L1, PD-2, CD137, CTLA-4, T cell, co-stimulation or drugs targeted on the checkpoint signal pathway.
  4. Previously treated with docetaxel.
  5. The histopathological subtype is not squamous cell non-small cell lung cancer, or squamous cell < 90% in a mixed carcinoma.

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 ClinicalTrials.gov identifier (NCT number): NCT04171284


Locations
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China, Shanghai
Shanghai Chest Hospital
Shanghai, Shanghai, China, 200030
Sponsors and Collaborators
Sinocelltech Ltd.
Investigators
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Principal Investigator: Han Baohui, M.D. Shanghai Chest Hospital
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Responsible Party: Sinocelltech Ltd.
ClinicalTrials.gov Identifier: NCT04171284    
Other Study ID Numbers: SCT-I10A-D301
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sinocelltech Ltd.:
Non-small cell lung cancer
Squamous cell carcinoma
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action