A Study Comparing the Efficacy and Safety Between IBI308 and Docetaxel in Patients With Advanced or Metastatic NSCLC

NCT03150875 | Completed Phase 3 Results DMC

• 1 other identifier: CIBI308C301
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 2

Brief Summary

Clinical trial results demonstrate that anti-PD-1 antibodies prolonged OS to approximately 9 months compared with 6 months in docetaxel group. Anti-PD-1 therapy in Chinese squamous NSCLC patients will be investigated in this clinical trial. Additionally, the correlation between PD-L1 expression and the response to IBI308 treatment in Chinese squamous cell NSCLC patients as well as the role of irRECIST in immune checkpoint inhibitor treatment evaluation will also be assessed

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival was defined as the time from randomization to death due to any cause.

  Through database cutoff date of 31-July-2020 (up to approximately 35 months)

Secondary Outcomes (4)

• Progression-free Survival by Investigators' Assessment

  Through database cutoff date of 31-July-2020 (up to approximately 35 months)

• Overall Response Rate (ORR) Per RECIST v1.1 as Assessed by Investigators

  Through database cutoff date of 31-July-2020 (up to approximately 35 months)

• Duration of Response (DOR) Per RECIST v1.1 as Assessed by Investigators

  Through database cutoff date of 31-July-2020 (up to approximately 35 months)

• Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE)

  Through database cutoff date of 31-July-2020 (up to approximately 35 months)

Study Arms (2)

IBI308

EXPERIMENTAL

injection; dosage form: 10ml:100mg; frequency: 200mgQ3W; duration: randomization to the date of the first documented tumor progression per RECIST v1.1 criteria

Drug: IBI308

docetaxel

ACTIVE COMPARATOR

injection; dosage form: 1ml:40mg; Frequency: 75mg/m2 Q3W; duration: randomization to the date of the first documented tumor progression per RECIST v1.1 criteria

Drug: Docetaxel

Interventions

IBI308 DRUG

Anti-PD-1 therapy in Chinese squamous NSCLC patients will be investigated in this clinical trial.

IBI308

Docetaxel DRUG

As 2nd line treatment to subjects with squamous NSCLC

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:

• Subjects with Histologically or cytologically confirmed squamous cell NSCLC
• Subjects with stage IIIB/stage IV or recurrent disease (not suitable for definitive concurrent chemoradiotherapy) (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) after failure of first-line platinum-based therapy; Subjects who developed recurrent disease \<6 months after platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy also could also be eligible.
• At lease one measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
• Age ≥ 18 and ≤ 75
• ECOG performance status 0-1
• Life expectancy of at least 12 weeks
• Adequate organ and bone marrow function
• CBC: absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; platelet count (PLT) ≥ 100 × 109 / L; hemoglobin content (HGB) ≥ 9.0 g / dL.
• Liver function: serum total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; serum albumin ≥ 28 g / L.
• Renal function: serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate (Ccr) ≥ 40 mL / min (calculated using Cockcroft / Gault equation) Female:CrCl= (140-Age) x Weight(kg) x 0.85 72 x Serum creatinine (mg/dL) Male:CrCl= (140-Age) x Weight(kg) x 1.00 72 x Serum creatinine (mg/dL)
• Subjects of reproductive potential must be willing to use adequate contraception during the course of the study and through 6 months after the last dose of study treatment.
• Voluntarily signed written informed consent form, willing and able to comply with scheduled visits and other requirements of the study

You may not qualify if:

• EGFR mutation and ALK rearrangement
• Mixed adeno-squamous carcinoma or other pathological type
• Prior therapy with anti-PD-1,anti-PD-L1,anti-CTLA4 antibody or docetaxel
• Have received following treatment:
• Received any investigational agent within 4 weeks of the first dose of study treatment.
• Received any anti-tumor therapy (chemotherapy, targeted therapy, tumor immunotherapy or arterial embolization) within 3 weeks of the first dose of study treatment.
• Received radiotherapy within 4 weeks of the first dose of study treatment.
• Received systemic treatment with high-dose corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive drugs within 4 weeks of first dose. Inhaled or topical steroids and adrenal replacement steroid are permitted in the absence of active autoimmune disease.
• Received attenuated live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during study period.
• Received major surgery (such as craniotomy, thoracotomy or laparotomy) within 4 weeks of the first dose of study drugs or open wound, ulcer or fracture.
• Unrecovered toxicity (grade \>1, according to NCI CTCAE 4.03) due to prior anti-tumor therapy before the first dose of study treatment.
• Subjects with active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis. Subjects with cured childhood asthma, type I diabetes mellitus and hypothyroidism only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment.
• Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation
• Known allergic or hypersensitive to docetaxel, any monoclonal antibody or any other components used in their preparation.
• Hemoptysis within 4 weeks of randomization (≥ 1/2 spoon per time).

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (2)

The First Affiliated Hospital Zhejiang University

Hangzhou, Zhejiang, China

Location

Jiangsu Cancer Hospital

Nanjing, China

Location

Related Publications (1)

• Shi Y, Wu L, Yu X, Xing P, Wang Y, Zhou J, Wang A, Shi J, Hu Y, Wang Z, An G, Fang Y, Sun S, Zhou C, Wang C, Ye F, Li X, Wang J, Wang M, Liu Y, Zhao Y, Yuan Y, Feng J, Chen Z, Shi J, Sun T, Wu G, Shu Y, Guo Q, Zhang Y, Song Y, Zhang S, Chen Y, Li W, Niu H, Hu W, Wang L, Huang J, Zhang Y, Cheng Y, Wu Z, Peng B, Sun J, Mancao C, Wang Y, Sun L. Sintilimab versus docetaxel as second-line treatment in advanced or metastatic squamous non-small-cell lung cancer: an open-label, randomized controlled phase 3 trial (ORIENT-3). Cancer Commun (Lond). 2022 Dec;42(12):1314-1330. doi: 10.1002/cac2.12385. Epub 2022 Nov 6.

  PMID: 36336841 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sintilimab; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Yi Bo
• Organization: Innovent Biologics (Suzhou) Co., Ltd. (seal)

jessica.yi@innoventbio.com

+86 13382419112

Study Officials

• Yuankai Shi, Doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2017
• First Posted: May 12, 2017
• Study Start: September 1, 2017
• Primary Completion: February 22, 2023
• Study Completion: February 22, 2023
• Last Updated: February 28, 2023
• Results First Posted: June 23, 2021

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)