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

NCT04171284 | Terminated Phase 3 DMC

• 1 other identifier: SCT-I10A-D301
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous-cell Non-Small-cell Lung Cancer

Keywords

Non-small cell lung cancer; Squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

  OS is the time from the date of randomization to death due to any cause.

  Up to approximately 3 years

Secondary Outcomes (9)

• 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

Study Arms (4)

SCT-I10A plus Docetaxel

EXPERIMENTAL

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; Drug: Docetaxel

Placebo puls docetaxel

ACTIVE COMPARATOR

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; Drug: Placebo

Maintenance therapy of SCT-I10A

EXPERIMENTAL

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

Maintenance therapy of Placebo

PLACEBO COMPARATOR

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

Interventions

SCT-I10 DRUG

200 mg, Q3W, maximum treatment up to six cycles

Also known as: human PD-1 monoclonal antibody

Maintenance therapy of SCT-I10A; SCT-I10A plus Docetaxel

Docetaxel DRUG

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

Placebo puls docetaxel; SCT-I10A plus Docetaxel

Placebo DRUG

200 mg, Q3W, maximum treatment up to six cycles

Maintenance therapy of Placebo; Placebo puls docetaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients should be voluntarily sign the written informed consent.
• Histologically or cytologically confirmed diagnosis of locally advanced or metastatic squamous NSCLC. Or recurrent squamous NSCLC according UICC/AJCC 8th edition.
• 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.
• 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.
• Progression after EGFR-TKIs in patients with driver gene mutation.
• Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.

You may not qualify if:

• Patient who is allergic to recombinant humanized PD-1 monoclonal antibody or the components of the drug.
• Patient who is allergic to taxane.
• 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.
• Previously treated with docetaxel.
• The histopathological subtype is not squamous cell non-small cell lung cancer, or squamous cell \< 90% in a mixed carcinoma.

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (1)

• Han B, Wu L, Yang R, Wu H, Li W, Yu Y, Zhang M, Sun H, Chu T, Zhong F, Fang Y, Wu R, Bian T, Guo X, Sun M, Zhang Y, Liu L, Liu X, Pan Y, Jiang O, Wei Z, Lin H, Guo W, Fang J, Wang J, Ding C, Hu Y, Ye F, Zhuang W, Ye S, Wang L, Huang Z, Liu C, Yang L, Wang J, Xie L. Efficacy and safety of finotonlimab plus docetaxel vs. docetaxel in previously treated advanced squamous cell non-small-cell lung cancer: a randomized, double-blinded, phase III trial. Transl Lung Cancer Res. 2025 Apr 30;14(4):1231-1241. doi: 10.21037/tlcr-24-1042. Epub 2025 Apr 16.

  PMID: 40386729 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous Cell

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Han Baohui, M.D.

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 20, 2019
• Study Start: October 22, 2019
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)