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

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

Patrocinadores

Patrocinador principal: Sinocelltech Ltd.

Fuente Sinocelltech Ltd.
Resumen breve

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.

Descripción detallada

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.

Estado general Active, not recruiting
Fecha de inicio October 22, 2019
Fecha de Terminación May 22, 2023
Fecha de finalización primaria October 22, 2022
Fase Phase 3
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Overall survival Up to approximately 3 years
Resultado secundario
Medida Periodo de tiempo
PFS Up to approximately 3 years
OSR of 6 months, 12 months and 18 moths Each subject that randomized will be followed up for 18 months to measure the OSR.
ORR Up to approximately 3 years
DOR Up to approximately 3 years
DCR Up to approximately 3 years
The concentration of anti-SCT-I10A antibodies in the serum of subjects Up to approximately 3 years
The expression level of PD-L1 of subjects' specimens Up to approximately 3 years
Cancer-specific quality of life of the regimens treated subjects Up to approximately 3 years
Lung cancer-specific quality of life of the regimens treated subjects Up to approximately 3 years
Inscripción 360
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: SCT-I10

Descripción: 200 mg, Q3W, maximum treatment up to six cycles

Otro nombre: human PD-1 monoclonal antibody

Tipo de intervención: Drug

Nombre de intervención: Docetaxel

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

Tipo de intervención: Drug

Nombre de intervención: Placebo

Descripción: 200 mg, Q3W, maximum treatment up to six cycles

Elegibilidad

Criterios:

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.

Género: All

Edad mínima: 18 Years

Edad máxima: 75 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Han Baohui, M.D. Principal Investigator Shanghai Chest Hospital
Ubicación
Instalaciones: Shanghai Chest Hospital
Ubicacion Paises

China

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 4
Grupo de brazo

Etiqueta: SCT-I10A plus Docetaxel

Tipo: Experimental

Descripción: SCT-I10A 200mg, I.V., Q3W; Docetaxel 70-75 mg per square meters of body surface area,I.V., Q3W. Maximum of 6 cycles

Etiqueta: Placebo puls docetaxel

Tipo: Active Comparator

Descripción: Placebo 200mg, I.V., Q3W; Docetaxel 70-75 mg per square meters of body surface area,I.V., Q3W Maximum of 6 cycles

Etiqueta: Maintenance therapy of SCT-I10A

Tipo: Experimental

Descripción: 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.

Etiqueta: Maintenance therapy of Placebo

Tipo: Placebo Comparator

Descripción: 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.

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Double (Participant, Investigator)

Fuente: ClinicalTrials.gov